Cholesterol-Lowering Supplements Review
(Sterols/Stanols and Policosanol)
Find the Best
Cholesterol-Lowering Supplement. See Which Plant Sterol and Policosanol
Supplements Passed Our Tests and Are Our Top Picks.
Medically reviewed and
edited by Tod Cooperman, M.D. 
Initially Posted:
04/20/2019
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Table of Contents
Summary
·
Do cholesterol supplements work? Although many types
of supplements are touted for lowering high cholesterol levels, those with the
best evidence of efficacy are sterols/stanols, red yeast rice, and
high-dose niacin. In this Review,
we tested sterols/stanols. There is modest evidence of efficacy for other
supplements such as policosanol (also tested in this Review), fish oil, garlic,
guggulsterone, pantethine,
soy protein, and Sytrinol (see Summary of Evidence table).
·
What did CL's tests find about cholesterol supplements? Tests by ConsumerLab revealed that one sterol product contained less
of a specific sterol than claimed and a policosanol product did not contain the
expected amount of a specific policosanol. Across products, the dose of
sterols/stanols per serving ranged from 400 mg to 900 mg and 10 mg to 20 mg of
policosanol. The cost to obtain 800 mg of sterols/stanols ranged from 16
cents to 74 cents and the cost for 20 mg of policosanol ranged from 11 cents
to 59 cents. (See What CL Found)
·
Top Picks for sterols and policosanol — Among products
Approved in testing, ConsumerLab selected a Top Pick for
sterols/stanols that provided an ample dose at
relatively low cost and its effectiveness is backed by a positive clinical
trial. The Top Pick for
policosanol provided what may be the best form of
policosanol and relatively low cost.
·
How much to take and when? Dosage for sterols is at least 400 mg
with a meal or (1,000 mg for stanols), twice daily. For policosanol, it is 10
to 20 mg daily. See the ConsumerTips™ section
for more about dosage and forms.
·
Safety and side effects of cholesterol supplements: Sterols/stanols may
interfere with absorption of fat-soluble vitamins and, rarely, their use has
been associated with elevations in liver enzymes. A range of side effects,
including migraines and insomnia, have been reported with policosanol and it
should be used with caution in people taking anti-platelet or anti-coagulant
drugs. (For details, see Concerns and Cautions.)
What They Are:
According
to the American Heart Association, 102.2 million Americans age 20 and older
(almost 50 percent of American adults) have elevated blood cholesterol levels,
a key risk factor for heart disease. Lifestyle changes such as improving diet,
losing weight and increasing exercise are often effective. Various supplement
ingredients may be helpful as well in lowering low-density lipoprotein (LDL or
"bad cholesterol"), raising high-density lipoprotein (HDL or
"good cholesterol"), and improving the LDL/HDL ratio. Some
supplements may also reduce triglycerides. Supplement ingredients that have
been used to reduce cholesterol include sterols and sterol esters (also called
phytosterols — or plant sterols, which are produced in the normal refinement of
vegetable oils, or, alternatively, as a byproduct of papermaking from the oil
of pinewood pulp), stanols and stanol esters (substances closely related to
sterols that are derived from the same sources), red yeast rice (a yeast grown
on rice), high doses of niacin (a B-vitamin), policosanol (a waxy substance
from sugar cane, beeswax, wheat germ or rice bran wax), guggulsterone
(a gum resin from a tree sap), garlic, fish oil, and soy protein. Soluble fiber
in the diet as well as moderate intake of alcohol can also improve cholesterol
levels.
What They Do:
The amount of evidence supporting the various
cholesterol-lowering supplements varies. The best evidence is for sterols,
stanols and their esters, red yeast rice and high dose-niacin (sold as a
supplement as well as a prescription drug). Be aware, however, that there are
safety concerns regarding the use of some of them. There is mixed evidence
for whether soy can lower cholesterol.
Below is a summary of information about several of the most popular ingredients
used for cholesterol-lowering. See ConsumerTips™ for
more information about the forms, suggested dosage, and safety considerations.
In addition to the uses indicated above, these ingredients have other potential
actions and uses.
It should be noted that while sterols and stanols can lower cholesterol, no
study has shown a direct reduction in the risk of cardiovascular disease
(see Concerns and Cautions below).
|
Summary of Evidence
for Cholesterol-lowering Ingredients |
||||
|
Ingredient |
Purported Use |
Evidence |
Safety |
Dosage and Tips for
Buying and Using |
|
DHA and EPA (Omega-3
Fish/Marine Oils) |
Does not affect LDL but can to significantly
decrease triglycerides and might raise HDL slightly. (Harris 1997; Woodman 2002) |
Fairly strong. |
Considered safe, but could theoretically cause
blood thinning problems at high doses (3 grams or more). |
|
|
Garlic |
Small reductions in total cholesterol, LDL and
triglycerides in early studies. More recent studies show little
benefit. (Khoo 2009) |
Inconsistent. |
Generally safe, but may thin blood and may
interact with drugs used for HIV infection. |
|
|
Guggulsterone |
Claimed to reduce LDL and triglycerides, but
current balance of evidence does not consistently support efficacy in Western
diet; the most recent and best designed study found that guggulsterones
worsened cholesterol profile by increasing LDL. (Szapary 2003; Ulbricht 2005) |
Weak and Inconsistent. |
May cause skin rash and other mild side
effects. One case report of potential muscle breakdown (rhabdomyolysis). |
May Typical dosage is
75 to 100 mg of guggulsterones in the E and Z
forms, divided into three doses daily. |
|
Niacin |
When taken at very high dose, niacin can
markedly improve cholesterol profile, especially HDL, which it can raise by
about 35%. Also decreases LDL by about 10% and triglycerides by about 25%. (Al-Mohaissen 2010) |
Very strong. |
At recommended dose can cause skin tingling,
flushing and potentially dangerous liver inflammation. |
|
|
Some studies suggest modest decrease in total
cholesterol, LDL, and triglycerides with rise in HDL. (Arsenio 1986) |
Inconsistent. |
May increase risk of bleeding by decreasing
platelet aggregation. |
Typical dosage is 300 mg three to four times
daily. |
|
|
Policosanol |
Studies from Cuba suggest that policosanol
from sugarcane can significantly lower total cholesterol and LDL. However,
all studies outside Cuba failed to find this effect. Other forms of
policosanol, such as beeswax- or wheat germ- derived, have undergone
relatively little study. (Berthold 2006; Kassis 2006; Kassis 2009) |
Inconsistent. |
Blood-thinning effects. Otherwise, generally
thought to be safe, but not well studied. |
|
|
Red Yeast Rice |
Contains naturally occurring lovastatin, a
prescription drug used to lower cholesterol; also contains numerous related
chemicals that may be active. Like statin drugs, red yeast rice appears to
lower total cholesterol, LDL, and triglycerides, while leaving HDL unchanged.
(Liu 2006) |
Fairly strong. Studies have shown over 20%
decline in LDL. But ConsumerLab.com tests show 100-fold variation across
marketed products. |
Presumably carries the same serious risks as
statin drugs, although a recent study showed that only 7% of
statin-intolerant people reported muscle pain when switched to red yeast rice
(Becker 2009). CL also found several products
contaminated with a potential kidney toxin - citrinin. Should not be used in
conjunction with statins, niacin, or drugs in the fibrate family. |
No longer marketed with standardized
lovastatin levels in U.S. due to legal issues. Now sold without lovastatin
levels declared. |
|
Soy Protein |
At best, when taken in adequate doses may
modestly lower total cholesterol and improve LDL/HDL ratio. (Zhan 2005) |
There is inconsistent evidence as to whether
soy lowers total and LDL cholesterol (FDA 2017) |
Generally safe when consumed as a food;
concentrated extracts could cause hormonal effects, particularly in
post-menopausal women. |
A typical dose is 20-50 grams per day. |
|
Sterols and Stanol Esters |
Review of studies found 9% decrease in LDL on
average (up to 15% has been reported) (Demonty 2009).
Do not affect HDL. |
Very strong. Work predominately by reducing
the absorption of dietary cholesterol in the gut, though can also eliminate
cholesterol that the liver recycles through the gut. |
Generally safe. Has additive effect with
statins. |
|
|
SytrinolTM |
Preliminary studies suggest reductions of
20-30% in total cholesterol, 19-27% in LDL, and 24-34% in triglycerides. |
Evidence is preliminary (two open label
studies and one controlled study). (Roza 2007) |
Generally well tolerated. |
Typical dosage is 300 mg per day. |
In this Product Review, testing focused on two of the supplement ingredients
noted above: policosanol and sterols. Reviews for fish oils (DHA and EPA), garlic, niacin, red yeast rice,
and soy protein have
been conducted and are posted elsewhere on this site.
Quality Concerns and
Tests Performed:
Neither
the FDA nor any other federal or state agency routinely tests supplements for
quality prior to sale or on the market. ConsumerLab.com tested each of the
products listed in the table below to confirm the amount of its key ingredient
and other quality parameters as follows: For sterols/stanol: The FDA permits sterol-containing
products to claim that they help reduce the risk of heart disease when used
with a diet low in saturated fat and cholesterol. To make the claim, the
product must provide a total of 800 mg of free sterols (1.3 grams of sterol
esters) divided into at least two servings per day and taken with meals. The
sterols must be comprised of at least 80% beta-sitosterol, campesterol,
and stigmasterol. Products making the "heart disease" health claim
were expected to meet these requirements.
For policosanol: Policosanol is a mixture of long chain alcohols
from sugar cane or rice bran wax. Consistent with amounts used in most clinical
studies, products were expected to contain at least 55% octacosanol
along with certain other long chain alcohols.
All tablet and caplet products were tested for their ability to disintegrate,
i.e., break apart, so that they could properly release their contents for use
by the body. For more information, see How Products were Evaluated.
What CL Found and Top Picks:
Sterols/stanols
All of the supplements contained their claimed total amounts
of sterols and/or stanols. However, Vibrant Health Cholesterol Blockers
Version 2.3 contained only 15.4% of its listed amount of a minor
sterol (brassicasterol) and, therefore, could not be
approved.
As shown in the graph below, as well as the Results table, the amounts of
sterols/stanols in a suggested serving of each product ranged from 400 mg to
900 mg, and most, if not all, of these amounts were sterols. The FDA requires at
least 400 mg per serving of sterols (based on the free form or non-esterified
portion of esterified forms) for a product to claim to help lower cholesterol
and all of the products met this requirement.
Although all of the values in the graph are based on the total sterols and
stanols, none of the products contained large amounts of stanols. Some of the
products provided sterols/stanols in the ester form (which may be preferable)
and these are indicated with an asterisk in the graph to the right of their
values. However, for ease of comparison, all the values are based on just the
amounts of sterols and stanols excluding the weight of the ester portions of
molecules.
Top Pick for Sterols/Stanols
Our clear Top Pick for a sterol/stanol supplement is Nature
Made CholestOff Plus as it provides the
right ingredients at the best price and even has a clinical study to support
its efficacy (see What to Consider When Buying).
Each 2-softgel serving of CholestOff
Plus claims to provide 900 mg of a combination of sterols and stanols.
Our tests showed that it did (actually, it contained 96.5% of this, but this is
within an acceptable range) and the vast majority of this was from sterols. The
FDA requires a minimum of only 400 mg of sterols per serving to make a
cholesterol-lowering claim, so CholestOff
Plus provides more than twice the minimum. CholestOff
Plus is also in the ester form, which may be more effective than the
free form and it is in softgel form, which may be
more effective than a tablet. (Other products in the ester form are Designs
for Health Foresterol and ModuChol.)
As shown in the graph below, CholestOff
Plus was, by far, the least expensive source of sterols/stanols, at
just 16 cents per 800 mg. The cost to obtain the same amount of sterols/stanols
from other products ranged from 47 cents to 74 cents.
It's worth noting that plant sterols, such as beta-sitosterol (the major sterol
in most of the products may also help relieve urinary symptoms of prostate enlargement (BPH).
Typically, much lower doses of beta-sitosterol (about 30 to 91 mg per day) are
used to help with BPH than with cholesterol-lowering, although, for BPH,
sterols are taken without food — to enhance absorption. In the Results table, at the bottom of the second
column for each product, are shown the amounts of beta-sitosterol found per
serving of each sterol/stanols product.
Policosanol:
All of the products contained their claimed total amounts of
policosanol, which ranged from 10 to 20 mg per serving, which is the range used
clinically. However, one product, Piping Rock Ultra Policosanol, contained a
lower percentage of one type of policosanol, octacosanol,
than ConsumerLab would expect from its claimed source
of policosanol, rice bran. Therefore, Piping Rock could not be
approved.
The Vitamin Shoppe Policosanol and Olympian Labs, Inc.
Policosanol 10 mg were the only other policosanol products to label
the source of ingredient — which was sugar cane wax. Although there is more
clinical evidence with policosanol from sugar cane than from rice or other
sources, as discussed below, not all evidence with sugar
cane is positive, so it is difficult to say which source, if any, is
preferable.
Comparing the cost to obtain an equivalent amount of policosanol (20 mg) from
the Approved products, the lowest cost was 25 cents from Solgar Policosanol 20, followed by 28 cents
for The Vitamin Shoppe Policosanol. For the other Approved
products, the cost was 40 cents or higher.
Top Pick for Policosanol
Based on its relatively low cost and the fact that it is made from sugar cane
wax, our Top Pick for policosanol is The Vitamin
Shoppe Policosanol, which provides 10 mg of policosanol per tablet. Its
label indicates that this is to be taken with meals twice daily.
See Testing Methods and Passing Score for
more information about the testing and criteria.
Test Results by Product:
Listed
below are the test results for ten supplements. Products are grouped by type of
ingredient(s) tested and are listed alphabetically within each group. Eight
products were selected by ConsumerLab.com and two others (each with a CL flask
icon) are included for having passed the same evaluation through ConsumerLab.com's Quality Certification Program.
Shown for each product is the claimed amount of the tested ingredient and the
daily serving size recommended on its label. Products listed as
"Approved" met their label claims and ConsumerLab.com's
quality criteria (see Passing Score). Price and cost comparisons are
shown in the third column, notable features are noted in the fourth column, and
the full list of ingredients is found in the last column.
Results of
ConsumerLab.com Testing of CHOLESTEROL-REDUCING SUPPLEMENTS
(Click arrows or swipe left or right to see all columns)
Approval Status 
Product Name
(Suggested Serving on Label)
Claimed Amountⓘ,
Source and Form of Key Ingredients Per Suggested Serving
Suggested Daily Serving on Label
Pill Sizeⓘ
Cost for Suggested Serving
[Cost for 800 mg phytosterols]
{Cost for 20 mg policosanol}
Price
Notable Features
Full List of Ingredients
(Per Serving)
Phytosterol Supplements:
APPROVED
Designs For Health® Foresterol™
Mfd. by Designs for Health, Inc.
1 softgel:
600 mg
sterols/stanols
Form: Ester
(Found 612.4 mg sterols and 24.7 mg stanols per serving)
[Found 462.4 mg beta-sitosterol]
As a
dietary supplement, take one softgel three times per
day with meals, or as directed by your health care practitioner.
Very large softgel
$0.43
[$0.57]
$38.64/90 softgels
Non-GMO
1 softgel:
Plant Sterols/stanols 600 mg.
Other Ingredients: Bovine gelatin, water, and glycerine
(softgel ingredients), curcumin (natural color).
APPROVED
ModuChol®
Dist. by Wakunga of
America Co. Ltd.
1 vegetarian capsule:
650 mg sterol esters (equivalent to 400 mg free plant sterols)
Form: Ester
[Found 162.7 mg beta-sitosterol]
Take one
capsule with a meal twice daily or as directed by a health care professional.
Large vegetarian capsule
$0.37
[$0.74]
$22.23/60 vegetarian capsules
Free Of: Gluten, dairy, sugar, preservatives,
artificial colors or flavors.
Precaution: May contain trace amounts of soy and peanuts.
1 vegetarian capsule:
Plant Sterol Esters 650 mg.
Other Ingredients: Vegetable cellulose and purified water.
APPROVED
Top Pick
Nature Made® CholestOff®
Plus
Dist. by Nature Made Nutritional Products
2 softgels:
900 mg sterol/stanol (from esters)
Form: Ester
(Found 863.6 mg sterols, 4.9 mg stanols per serving)
[Found 751.7 mg beta-sitosterol]
Take two softgels two times daily with your two largest meals.
Large softgel
$0.19
[$0.16]
$19.49/210 softgels
No Synthetic Dyes. No Artificial Flavors. No
Preservatives. No Yeast or Starch. Gluten Free.
Precaution: Contains Soy.
2 softgels:
Calories 10, Total Fat 1 g, Plant sterols/stanols (from esters) 900 mg.
Ingredients: Plant Sterols/Stanols (Pine Tree), Sunflower Oil Esters, Gelatin
(Porcine), Glycerin, Medium Chain Triglycerides, Soy Lecithin, Water, Colors
Added.
APPROVED
ProCaps Laboratories CholestaCare™
Dist. by ProCaps Labs
2 capsules:
800 mg proprietary sterol blend (CholestaCare™)
(Found: 836.3 mg of free sterols per 2 capsule
serving)
Form: Free
[Found 384.3 mg beta-sitosterol]
Consume
one capsule with small meals or snacks and two capsules with larger meals.
Minimum effective dosage is 2 capsules daily. There is no increased benefit
from taking more than 2 capsules per meal or a total of six capsules daily.
Large capsule
$0.60
[$0.60]
$17.90/60 capsules
Contains No Common Allergens Of
Any Kind.
2 capsules:
CholestaCare™ [Proprietary Sterol Blend] 800 mg.
Other Ingredients: Gelatin capsule, Vegetable Magnesium Stearate and Silicon
Dioxide.
Policosanol Supplements:
APPROVED
GNC Policosanol 10 mg
Dist. by General Nutrition Corporation
1 tablet:
10 mg policosanols (source not stated)
As a
dietary supplement, take one tablet daily.
Medium circular tabletⓘ
$0.20
{$0.40}
$11.99/60 tablets
No Sugar, No Artificial Colors, No Artificial
Flavors, No Preservatives, Sodium Free, No Wheat, Gluten Free, No Corn, No Soy,
No Dairy, Yeast Free.
1 tablet:
Policosanol 10 mg.
Other Ingredients: Dicalcium Phosphate, Cellulose.
APPROVED
Olympian Labs, Inc. Policosanol 10 mg
Dist. by Olympian Labs, Inc.
1 vegetarian capsule:
10 mg policosanols (from sugar cane wax)
As a
dietary supplement, take one (1) capsule daily or as directed by a healthcare
professional.
Medium/large vegetarian capsule
$0.21
{$0.42}
$12.58/60 vegetarian capsules
Vegan. Gluten Free. Allergen Free. Non-GMO.
1 vegetarian capsule:
Policosanol (Sugar Cane Wax - (Saccharum officinarum)) 10 mg.
Other Ingredients: Vegetarian Capsule (HPMC), Rice Flour, Microcrystalline
Cellulose (Plant Fiber), Silicon Dioxide, Ascorbyl
Palmitate.
NOT APPROVED
(Low in octacosanol)
Piping Rock Ultra Policosanol
Mfd. by Piping Rock Health Products
1 capsule:
20 mg policosanols (from rice bran)
Found octacosanol to be 18.6% of total policosanols, but should
be at least 30%.
For
adults, take one (1) quick release capsule one to two times daily, preferably
with meals.
Medium/large capsule
$0.11
{$0.11}
$10.69/100 capsules
No Gluten, Wheat, Yeast, Milk, Lactose, Soy,
Artificial Color, Artificial Flavor, Artificial Sweetener, Preservatives.
Non-GMO.
1 capsule:
Policosanol (from rice bran wax) [Contains Naturally Occurring: Octacosanol, Triacontanol, Hexacosanol]
20 mg.
Other Ingredients: Rice Powder, Gelatin Capsule, Vegetable Magnesium Stearate.
APPROVED
Solgar® Policosanol 20 mg
Mfd. by Solgar, Inc.
1 vegetable capsule:
20 mg policosanols (source not stated)
As a
dietary supplement for adults, take one (1) vegetable capsule daily, preferably
with a meal or as directed by a healthcare practitioner.
Medium/large vegetable capsule
$0.25
{$0.25}
$24.83/100 vegetable capsules
Kosher. Gluten, Wheat & Dairy Free. Non-GMO.
Suitable For Vegans. Free Of: Gluten, Wheat, Dairy, Soy, Yeast, Sugar, Sodium,
Artificial Flavor, Sweetener, Preservatives and Color.
1 vegetable capsule:
Policosanol 20 mg.
Other Ingredients: Microcrystalline Cellulose, Vegetable Cellulose, Vegetable
Magnesium Stearate.
APPROVED
Top Pick
The Vitamin Shoppe® Policosanol
Dist. by Vitamin Shoppe, Inc.
1 tablet:
10 mg policosanols (from sugar cane wax)
As a
dietary supplement, take one (1) tablet twice daily with meals.
Medium circular tabletⓘ
$0.14
{$0.28}
$16.99/120 tablets
Does not contain: Yeast, Corn, Wheat, Gluten,
Sugar, Salt, Soy, Starch, Dairy, Citrus, Fish, Nuts, Animal Derivatives,
Preservatives, Artificial Colors and Artificial Flavors.
1 tablet:
Policosanol (from sugar cane wax) 10 mg.
Other Ingredients: Dicalcium phosphate, microcrystalline cellulose, stearic
acid, magnesium stearate, croscarmellose sodium, purified water,
hydroxypropyl-methyl cellulose, polyethylene glycol.
Phytosterol/Policosanol Combination:
NOT APPROVED
(Low in brassicasterol)
Vibrant Health® Cholesterol Blockers™ Version
2.3
Dist. by Vibrant Health
1 chewable tablet:
553 mg soy phytosterols
Form: Free
>210 mg beta-sitosterol
[Found 230 mg beta-sitosterol]
>79 mg stigmasterol
>79 mg campesterol
>45 mg brassicasterol
Found only
6.9 mg brassicasterol (15.4% of listed amount)
10 mg policosanols (from sugar cane)
6 mg octacosanol
As a
dietary supplement, chew one (1) tablet immediately before, during, or
immediately after a meal containing cholesterol.
Large heart-shaped chewable tablet
$0.29
[$0.47]
{$0.59}
$17.60/60 chewable tablets
Suitable for vegetarians.
1 chewable tablet:
Total Carbohydrates 1 g, Total Sugars 1 g, Includes 1 g Added Sugars, Soy 95%
phytosterols extract (anti-nutrient-free, Non-GMO) [providing Total
phytosterols from 500 mg: Beta-Sitosterol (soy) >210 mg, Stigmasterol (soy)
>79 mg, Campesterol (soy) >79 mg, Brassicasterol (soy) >45 mg], Policosanol 60% octocosanol [from sugar can (Saccharum sinensis)
wax] 10 mg.
Other Ingredients:, more...
Unless otherwise noted, information about the
products listed above is based on the samples purchased by ConsumerLab.com (CL)
for this Product Review. Manufacturers may change ingredients and label
information at any time, so be sure to check labels carefully when evaluating
the products you use or buy. If a product's
ingredients differ from what is listed above, it may not necessarily be of the
same quality as what was tested.
The information contained in this report is
based on the compilation and review of information from product labeling and
analytic testing. CL applies what it believes to be the most appropriate
testing methods and standards. The information in this report does not reflect
the opinion or recommendation of CL, its officers or employees. CL cannot
assure the accuracy of information.
Copyright ConsumerLab.com, LLC, 2021 All
rights reserved. Not to be reproduced, excerpted, or cited in any fashion
without the express written permission of ConsumerLab.com LLC
ConsumerTips™:
§ Sterols (and Stanols): Although small
amounts of plant sterols are present in the diet, larger amounts are needed to
reduce cholesterol levels. Look for products that provide a minimum of 1,300 mg
(1.3 grams) of total plant sterol esters (equivalent to about 800 mg free
sterols) [or 3,400 mg of plant stanol esters (equivalent to 2,000 mg of free
stanols] divided over two or more servings per day, e.g., 400 mg of sterols or
1,000 mg of stanols, based on the nonesterified
("free") portions of the molecules. It has been the FDA's position that supplements and foods
that provide at least this amount of sterols may reduce the risk of heart
disease when part of a diet low in saturated fat and cholesterol.
Although it has not come to pass, note that, in 2010 the FDA considered raising this minimum daily
amount required make the above health claim to 2,000 mg of
"phytosterols," with this term representing the weight of the nonesterified (free) portion of plant sterols or plant
stanols, whether or not they are esterified. Recognizing that this amount can
be divided between meals and snacks over the course of the day, the FDA
proposed that products making a coronary heart disease claim deliver a minimum
of 500 mg of phytosterols per serving. The proposed rule would cover all types
of foods -- not just spreads and dressings. For dietary supplements, however, only
those containing esterified phytosterols, as opposed to nonesterified
phytosterols, would be able to make the claim, due to the current strength of
evidence for the former but not the later when supplied as supplements.
As brought to attention by a lawsuit filed in 2012, the popular
product Smart Balance Spreadable Butter (not tested in this
Review) claims to block cholesterol absorption but contains only 100
milligrams of phytosterols per tablespoon serving and an entire 7.5 oz
package contains less than 2 grams of phytosterols. The suit contends that the
health claim on the product is misleading because the amount of plant sterols
in a single serving of the spread has not been shown to block cholesterol
absorption or lower cholesterol levels. In contrast, a similar suit filed against the makers
of Benecol spread
was dismissed in September 2012 largely because Benecol contains 850 mg of phytostanols
per serving, which meets the FDA's proposed minimum of 500 mg.
A clinical study published in 2011 evaluated the
product CholestOff, which provides 1,800
mg daily of mixed free stanols and sterols divided into two servings taken with
meals. Participants in the study, who had elevated LDL levels, were first put
on a low-cholesterol diet (the "TLC Diet") for
several weeks to establish baseline cholesterol levels. Taking CholestOff for six weeks, in addition to the
ongoing diet, lowered LDL cholesterol from the baseline by about 4% and total
cholesterol by about 3% (Maki, 2011). While these reductions were
clinically significant, they are less dramatic than those seen in some other
studies, possibly because the participants were already on a low-cholesterol
diet. Interestingly, a similar study which used esterified (rather
than free) sterols and stanols (2,900 mg of esterified sterols
and stanols equivalent to 1,800 mg of the free type) in a softgel
capsule (rather than a tablet) yielded larger changes: LDL fell 9.2% and total
cholesterol fell 7.4% from baseline levels (Maki, 2012). Triglycerides decreased 9.1% from
baseline in the softgel study (but did not
significantly decrease in the tablet study). HDL levels were not significantly
affected in either the softgel or tablet studies.
This esterified, softgel version of CholestOff is sold as CholestOff
Plus and, based on these studies, it may be more effective than CholestOff. Cholestoff
Plus was tested as part of this Review (see Results table above).
Successful clinical trials have also used doses up to 3 grams of total plant
sterol esters or 1,800 mg of free sterols (Lau 2005; Vanstone 2002). Plant stanol esters may have
the same effect, although at a slightly higher amount — 3.4 grams divided over
two or more servings per day. However, a study in
Spain, which involved advice on diet and exercise, showed that a smaller dose
(2 grams of stanol esters) in a yogurt drink consumed each day after the main
meal reduced LDL cholesterol by slightly more than 10% among people with high
cholesterol. The improvement was apparent after 3 months as well as at one year
when the study was completed. The improvement was significant compared to a 1%
decrease in LDL for those who received the yogurt drink without stanols (Parraga-Martinez, Rev Esp Cardiol 2015).
If a product contains plant sterol esters, the sum of free beta-sitosterol, campesterol and stigmasterol should not be less than 80% of
the total claimed amount.
Using with statins and red yeast rice
Several clinical studies show that adding sterols or stanols, usually
incorporated in a margarine or spread, to statins results in an additional 7%
to 10% reduction in LDL cholesterol (Blair, Am J Cardiol 2000; Cabezas, J Am Diet Assoc 2006). One study
found a greater effect -- the addition of a sterol-containing margarine to a
statin resulted in a similar cholesterol-lowering effect as doubling the statin
dose (Simons, Am J Cardiol 2002).
These data suggest that adding a sterol or stanol to statin therapy may be
appropriate for people who need additional cholesterol-lowering, but cannot
tolerate higher statin doses. It is not known, however, if a lower statin dose
plus a sterol or stanol has the same benefits for reducing heart attack risk as
using a higher statin dose.
Red yeast rice is a supplement which contains natural statins and is sometimes
combined with sterols or stanols (see Red Yeast Rice Supplements Review). The extent to which this combination is more effective than
taking each supplement alone may depend on the dose of each. An 8-week study in
Italy among adults with moderately elevated cholesterol levels found that
taking 800 mg of plant sterols daily lowered LDL cholesterol slightly but not
to a statistically significant degree, while taking red yeast rice (providing 5
mg of monacolins — the specific amount of lovastatin not reported) lowered LDL
by 20.5%, and the combination of both supplements lowered LDL cholesterol by
27% -- which was significantly greater than with red yeast rice alone (Cicero, Nutr
& Metab 2017). However, a clinical
study in the U.S. using more than twice the dose of phytosterols and involving
more lovastatin from red yeast rice found that 900 mg of plant sterols in
tablet form twice daily or 1,800 mg of red yeast rice twice daily (providing 7
mg of lovastatin daily) each reduced LDL cholesterol by about 25%, but the
combination did not further reduce LDL levels (Becker, Am Heart J 2013 --
ConsumerLab.com worked with the researchers in this study to determine the
chemical composition of the sterol and red yeast rice products used). It
appears that, at moderate doses, taking a combination of sterols and red yeast
rice can be worthwhile, but there is less additive effect at higher doses.
Using with fish oil
A well-controlled study in 332 adults with high or border-line high levels of
cholesterol given a spread containing plant sterols and varying amounts of
omega-3 fatty acids from fish oil showed that the addition of fish oil did not
diminish the cholesterol-lowering effect of the sterols and appears to have
provided additional benefit. The spread, which was applied daily to bread and
foods for 4 weeks, contained 2,500 mg of sterols (free form) and 0 mg, 900 mg,
1,300 mg or 1,800 mg of EPA + DHA (2:1 ratio). Compared to those who received a
placebo spread, LDL ("bad") cholesterol levels fell by 11.7% among
those receiving only plant sterols and by 11.5%, 12.7%, and 14.7%, respectively,
among those receiving spreads that included EPA + DHA in the amounts listed
above. A modest, but statistically significant, increase in HDL
("good") cholesterol also occurred in the group receiving the highest
amount of EPA+DHA (Ras,
The J of Nutr 2014). Although
the participants did not have elevated levels of triglycerides, these levels
decreased in the groups receiving spreads with the two highest amounts of EPA +
DHA (an established effect of fish
oil).
Using with curcumin
Some evidence suggests that bioavailability-enhanced forms
of curcumin can modestly lower cholesterol. A study in Australia among older
people with high cholesterol levels found those who took 1,000 mg of a
bioavailability-enhanced curcumin formula (Meriva — providing 200
mg of curcumin) in addition to 25 grams of a phytosterol-enriched fat spread (Logicol Original — providing 2 grams of
phytosterols) had average decreases in total and LDL cholesterol of 11% and
14.4%, respectively, as compared with decreases of 4.8% and 8.1% with only the
phytosterol. Those who took only the curcumin had slight but
non-significant decreases in total or LDL cholesterol. There were no
significant changes in HDL good cholesterol or triglyceride levels (Ferguson, Metabolism 2017).
§ Policosanol: All positive studies have been conducted using policosanol
from sugar cane; other forms of policosanol (such as from rice bran wax) differ
in their composition and none have been found effective in studies; more
recently, the efficacy of sugar cane policosanol has also been placed in doubt.
Policosanol includes a variety of long-chain alcohols, such as octacosanol. A Cuban research group that has done most of
the research on and marketing of sugarcane policosanol claims that you should
look for products that contain no less than 60% (%wt/wt) octacosanol (although current
specifications in the market are approximately 50 to 55%). In addition, they
state that the sum of octacosanol, tetracosanol, hexacosanol, heptacosanol, triacosanol and nonacosanol should represent no less than 85% (%wt/wt). However, research
conducted outside of Cuba on Cuban policosanol and other sugarcane policosanols
with a similar profile have shown no significant benefit.
§ Sterols: Plant sterols should be taken with meals in
order to block cholesterol absorption. Reduction in cholesterol is typically
seen within a few weeks, but the full effect can take about three months. If
you use beta-sitosterol (a sterol) to treat symptoms of enlarged prostate,
realize that, unlike sterols used for cholesterol-lowering that work in the
gut, beta-sitosterol must be absorbed and should be taken on an empty
stomach to increase its absorption.
§ Policosanol: The typical recommended dose is 5-10 mg twice daily;
however even this amount may not be effective, and only sugarcane policosanol
has any supporting evidence for benefit, thought recent studies place this
benefit in doubt.
Concerns
and Cautions:
§ Sterols, Stanols and
their Esters: These substances
are generally considered to be quite safe. As noted above, clinical studies
have generally used 2 to 3 grams of sterols/stanols daily, and a daily dose as
high as 8.8 grams of plant stanol esters taken for 12 weeks was not found to
have adverse effects on liver enzymes or blood cells, or decrease blood levels
of vitamin A, E and D, although it did decrease blood levels of beta-carotene (Gylling, Clin Nutr 2010). However, be aware that
elevated liver enzymes have been reported in individuals taking a particular
sterol supplement (see details below).
Due to the possible inhibition of beta-carotene and other carotenoids (such as
lutein and zeaxanthin) (Baumgartner, Eur J Nutr 2017; Katan, Mayo Clin Proc 2003), consider increasing
intake of fruits and vegetables, or using a nutritional supplement (taken at a
different time than sterols and stanols).
There is some concern about raising the level of plant sterols in the blood
(which occurs with supplementation), because elevated plasma levels have been
associated with increased risk of coronary artery disease in some, but not all,
epidemiologic studies. A 12-week study of plant sterols (3 grams of
sterol esters -- per day from a low-fat spread used with meals), however, found
no impact on arterial function, despite reducing levels of LDL
("bad") cholesterol by 6.7% (Ras, Am J Clin Nutr 2015).
At the same time, the study raises the question of the overall benefit of
sterols if they improve cholesterol levels but do not improve the functioning
of arteries.
Beta-sitosterol is usually well tolerated but, in some patients, it can cause
nausea, indigestion, gas, diarrhea, or constipation. Although rare, erectile
dysfunction and/or loss of libido were reported in 1% of men taking
beta-sitosterol (20 mg three times daily for 6 months) (Berges, Lancet 1995).
Beta-sitosterol is contraindicated in patients with sitosterolemia, a rare
disorder in which total body stores of beta-sitosterol are significantly
increased.
Elevated liver enzymes were associated with the use of a
plant sterol supplement ( Cholestoff ,
Nature Made) in two individuals (a 59 year old woman and a 52 year old man);
enzyme levels returned to normal within two months of stopping supplementation
(Hoang, The Endocrine Society 2012).
Other than these case reports, there do not appear to be other case reports, or
reports from clinical trials, of this adverse effect.
§ Policosanol: A range of side
effects have been reported, including migraines, insomnia, sleepiness,
irritability, dizziness, upset stomach, increased drinking, painful urination,
weight loss, skin rash. According to the Cuban research group whose efficacy
research has been placed in doubt, policosanol can inhibit platelet
aggregation; nose and gum bleeding have been reported. Consequently, it should
be used cautiously with anti-platelet or anti-coagulant drugs.
References:
Al-Mohaissen MA et
al. Niacin: From mechanism of action to therapeutic uses. Mini Rev Med Chem 2010 Feb 19.
Arsenio L, Bodria P, Magnati G, et al. Effectiveness of long-term treatment with
pantethine in patients with dyslipidemia. Clin Ther 1986;8:537-45.
Becker et al. Red yeast rice for dyslipidemia in
statin-intolerant patients. Annals Int Med 2009; 150: 830-839.
Berthold HK et al. Effect of policosanol on lipid levels
among patients with hypercholesterolemia or combined hyperlipidemia: a
randomized controlled trial. JAMA 2006; 295(19): 2262-9.
Demonty I et al. Continuous
dose-response relationship of the LDL-cholesterol-lowering effect of
phytosterol intake. J Nutr
2009; 139(2): 271-84.
Harris WS. N-3 fatty acids and serum lipoproteins: human
studies. Am J Clin Nutr
1997; 65(5 Suppl):1645S-1654S. Review
Kassis A and Jones P. Lack of
cholesterol-lowering efficacy of Cuban sugar cane policosanols in
hypercholesterolemic persons. Am J Clin Nutr 2006; 84: 1003-8.
Kassis A et al. Sugar cane
policosanols do not reduce LDL oxidation in hypercholesterolemic
individuals. Lipids 2009; 44: 391-396.
Khoo YS and Aziz, A. Garlic supplementation and serum
cholesterol: a meta-analysis. J Clin Pharm Ther 2009; 34(2):
133-45.
Lau VW, et al. Plant sterols are efficacious in lowering plasma
LDL and non-HDL cholesterol in hypercholesterolemic type 2 diabetic and
nondiabetic persons. Am J Clin Nutr
2005 81:1351-1358.
Liu J, et al. Chinese red yeast rice (Monascus
purpureus) for primary hyperlipidemia: a
meta-analysis of randomized controlled trials. Chin Med 2006; 1:4.
Maki KC, et al. Lipid-altering effects of a dietary supplement
tablet containing free plant sterols and stanols in men and women with primary hypercholesterolaemia: a randomized, placebo-controlled
crossover trial. Int J Food Sci Nutr.
published online Nov 17 2011.
Maki KC, et al. Lipid effects of a dietary supplement softgel capsule containing plant sterols/stanols in primary
hypercholesterolemia. Nutrition 2013.
Roza JM et al. Effect of citrus flavonoids and
tocotrienols on serum cholesterol levels in hypercholesterolemic
subjects. Altern Ther
Health Med 2007; 13(6): 44-8.
Szapary PO et al. Guggulipid for the treatment of hypercholesterolemia: a
randomized controlled trial. JAMA 2003; 290(6): 765-72.
Ulbricht C et al. Guggul for hyperlipidemia: a review by
the Natural Standard Research Collaboration. Complement Ther
Med 2005; 13(4): 279-90.
Woodman RJ et al. Effects of purified eicosapentaenoic
acid and docosahexaenoic acids on glycemic control, blood pressure, and serum
lipids in type 2 diabetic patients with treated hypertension. Am J Clin Nutr 2002;76:1007-15.
Vanstone CA, et al. Unesterified plant sterols and stanols
lower LDL-cholesterol concnetrations equivalently in
hypercholesterolemic persons. Am J Clin Nutr.
2002; 76:1272-1278.
Zhan S and Ho SC. Meta-analysis of the effects of soy protein
containing isoflavones on the lipid profile. Am J Clin Nutr 2005; 81(2):
397-408.
Information on this site
is provided for informational purposes only. It is not an endorsement of any
product nor is it meant to substitute for the advice provided by physicians or
other healthcare professionals. The information contained herein should not be
used for diagnosing or treating a health problem or disease. Consumers should
inform their healthcare providers of the dietary supplements they take.
Latest Clinical Research Updates for Cholesterol-Lowering
Supplements (Sterols/Stanols and Policosanol)
Lowering Cholesterol with Red Yeast Rice and Phytosterols
9/27/2017
Red yeast rice and
phytosterols help lower cholesterol through different mechanisms. Does
combining them help more? See what two studies found in the ConsumerTips
section of the Cholesterol-Lowerers
Review >>
7/29/2015
Many studies have shown
that plant sterols and stanols can help lower levels of LDL "bad"
cholesterol. A new placebo-controlled study, which involved advice on diet and
exercise, found benefit with a slightly lower dose of stanols than typically
recommended. Get the details in the "What to Consider When Buying"
section of the Cholesterol-Lowering Supplements
Review »
6/10/2015
Many studies have shown
that taking plant sterols with meals can lower levels of LDL "bad"
cholesterol. While that's a good thing, a recent study questions whether this
reduces the risk of cardiovascular disease — the main target of treatment. Get
the details in the "Concerns and Cautions" section of the Cholesterol-Lowering Supplements
(Sterols and Policosanol) Review >>
8/31/2014
A new study found that
adding EPA and DHA from fish oil to a spread containing plant sterols is not a
problem and may provide additional benefit for those with high cholesterol
levels. For more information, including dosage amounts, see the update in
the Review of Cholesterol-Lowerers >>
5/27/2013
It is well known that
taking a red yeast rice supplement can cause large reductions in LDL
"bad" cholesterol and that sterol or stanol esters can lead to modest
reductions. But does combining them result in greater benefits than using
either alone? A new study says no. It's unclear, however, whether this is
always the case. Get details in the updated Red Yeast Rice Supplements Review
>>. Also see the updated, Cholesterol Lowering Supplements
Review >>