CoroWise® (Plant Sterols for Cholesterol — Cargill)

Evidence Level
Strong
3 Clinical Trials
3 Documented Benefits
4/5 Evidence Score

CoroWise is Cargill's brand of plant sterols (phytosterols), compounds that resemble cholesterol and reduce how much cholesterol the gut absorbs. Most evidence is for plant sterols as a class. In one 8-week trial, orange juice with 2 g a day of plant sterols lowered LDL cholesterol by 12.4%, and a 2004 review identifies those sterols as CoroWise. A meta-analysis of 84 randomized trials found an average 2.15 g a day lowered LDL by about 8.8%, and an analysis of 124 studies found 0.6 to 3.3 g a day lowered it by 6 to 12%; Unilever scientists led both. FDA's codified health claim covers plant sterol esters; a 2003 FDA letter to Cargill said FDA would consider enforcement discretion for free plant sterols, and a 2010 proposed update has not been finalized. These trials measured LDL cholesterol, a risk marker, not heart attacks, strokes or deaths. People with the rare condition sitosterolemia should avoid them.

Studied Dose About 2 g a day of plant sterols in pooled trials (mean 2.15 g); 0.6 to 3.3 g a day lowered LDL by 6 to 12%. Best taken with meals, split across the day.
Active Compound Plant sterols (phytosterols), mainly beta-sitosterol, campesterol and stigmasterol.

Benefits

Helps maintain healthy LDL cholesterol

A meta-analysis of 84 randomized trials found that an average 2.15 g a day of plant sterols or stanols lowered LDL cholesterol by about 8.8% (0.34 mmol/L), with larger absolute drops in people starting higher. A later analysis of 124 studies found 0.6 to 3.3 g a day lowered LDL by 6 to 12%. Both were led by Unilever scientists, and neither was specific to CoroWise.

US health claim status for plant sterols

FDA's codified claim (21 CFR 101.83) covers plant sterol esters at 1.3 g a day. In a 2003 letter to Cargill, FDA said it would consider enforcement discretion for foods with at least 400 mg of free or esterified phytosterols per serving and 800 mg a day. A 2010 proposal to set 2 g a day was not finalized. The claim concerns LDL, not proven fewer heart attacks.

LDL lowering in a fortified orange juice trial

In a randomized, placebo-controlled trial in 72 healthy adults with mildly high cholesterol, orange juice providing 2 g a day of plant sterols for 8 weeks lowered LDL cholesterol by 12.4% and apoB by 9.5%, without changing HDL or triglycerides. The abstract does not name the sterol, but a 2004 review identifies it as Cargill's CoroWise in Minute Maid juice.

Mechanism of action

1

Cholesterol absorption inhibition

Plant sterols compete with cholesterol for a place in the mixed micelles that carry it into intestinal cells, so less dietary and biliary cholesterol is absorbed. This is the main proposed mechanism.

2

Structural similarity to cholesterol

Plant sterols are shaped like cholesterol but are themselves absorbed very poorly, which lets them interfere with cholesterol uptake without building up in most people.

3

LDL receptor response

With less cholesterol arriving from the gut, the liver is thought to take up more LDL from the blood, which lowers circulating LDL cholesterol.

Clinical trials

1
Phytosterol dose and LDL cholesterol: meta-analysis of 84 trials
PubMed

Meta-analysis of 84 randomized trials (141 trial arms) in adults, building a continuous dose-response curve; first author from Unilever R&D (Demonty et al. 2009, J Nutr)

Adults in 84 randomized trials of plant sterols or stanols in various foods.

A mean 2.15 g a day lowered LDL cholesterol by 0.34 mmol/L (8.8%). Higher starting LDL gave larger absolute drops; sterols and stanols, and fat-based and non-fat foods, worked similarly. Trials measured LDL, not heart attacks or deaths.

2
Plant sterols and stanols by dose range: meta-analysis of 124 studies
PubMed

Meta-analysis of 124 randomized studies (201 strata) grouped by dose; authors from Unilever R&D and Wageningen University (Ras et al. 2014, Br J Nutr)

Adults in 124 studies; average dose 2.1 g a day (range 0.2 to 9.0 g).

Intakes of 0.6 to 3.3 g a day lowered LDL cholesterol by 6 to 12% on average, with the effect rising up to about 3 g a day. Plant sterols and stanols behaved alike.

3
Plant sterol-fortified orange juice
PubMed

Randomized, placebo-controlled trial of nonfat orange juice providing 2 g a day of plant sterols for 8 weeks after a 2-week run-in; the abstract does not name the sterol, which a 2004 review identifies as Cargill's CoroWise (Devaraj et al. 2004, Arterioscler Thromb Vasc Biol)

72 healthy adults with mildly high cholesterol.

LDL cholesterol fell 12.4%, total cholesterol 7.2% and apoB 9.5% compared with placebo juice and baseline; HDL and triglycerides did not change.

Side effects and drug interactions

Common Potential side effects

Generally well tolerated.
Mild digestive upset is occasionally reported.
People with sitosterolemia, a rare inherited condition in which plant sterols are absorbed and build up, should avoid plant sterol products.

Important Drug interactions

Statins: plant sterols add to LDL lowering; use together only with your prescriber's knowledge, and do not change a statin dose on your own.
Ezetimibe: also reduces cholesterol absorption, so the added benefit may be smaller; ask your prescriber.
Bile acid sequestrants: may bind plant sterols; separate doses.

Frequently asked questions about CoroWise® (Plant Sterols for Cholesterol — Cargill)

What is CoroWise?

CoroWise is Cargill's brand of plant sterols (phytosterols), compounds that resemble cholesterol and reduce how much cholesterol the gut absorbs. Most evidence is for plant sterols as a class. In one 8-week trial, orange juice with 2 g a day of plant sterols lowered LDL cholesterol by 12.

What is CoroWise used for?

CoroWise is researched primarily for Cardiovascular. A meta-analysis of 84 randomized trials found that an average 2.15 g a day of plant sterols or stanols lowered LDL cholesterol by about 8.8% (0.34 mmol/L), with larger absolute drops in people starting higher.

What is the recommended dosage of CoroWise?

The clinically studied dose is About 2 g a day of plant sterols in pooled trials (mean 2.15 g); 0.6 to 3.3 g a day lowered LDL by 6 to 12%. Best taken with meals, split across the day. Always follow the product label and check with a healthcare provider for personal advice.

Is CoroWise safe, and does it have side effects?

Side effects and cautions reported for CoroWise include: Generally well tolerated. Mild digestive upset is occasionally reported. It may also interact with some medications. CoroWise is not right for everyone, so check with a healthcare provider first if you are pregnant or breastfeeding, have a medical condition, or take prescription medication.

Does CoroWise interact with any medications?

Possible interactions include: Statins: plant sterols add to LDL lowering; use together only with your prescriber's knowledge, and do not change a statin dose on your own. Ezetimibe: also reduces cholesterol absorption, so the added benefit may be smaller; ask your prescriber. If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for CoroWise?

NutraSmarts rates the evidence for CoroWise as Strong (4 out of 5). It is backed by 3 study summaries and 6 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(6 citations)

Evidence ratings on NutraSmarts are based on the totality of human clinical research, with emphasis on randomized controlled trials, meta-analyses, and systematic reviews. The references below directly support claims made throughout this page.

  1. Demonty I, Ras RT, van der Knaap HC, Duchateau GS, Meijer L, Zock PL, Geleijnse JM, Trautwein EA. Continuous dose-response relationship of the LDL-cholesterol-lowering effect of phytosterol intake. J Nutr. 2009;139(2):271-84. doi: 10.3945/jn.108.095125.PubMedUsed to support: Meta-analysis of 84 randomized trials of plant sterols and stanols (not CoroWise-specific): a mean 2.15 g a day lowered LDL by 0.34 mmol/L (8.8%), with larger absolute drops at higher starting LDL. First author affiliated with Unilever R&D.
  2. Abumweis SS, Barake R, Jones PJ. Plant sterols/stanols as cholesterol lowering agents: A meta-analysis of randomized controlled trials. Food Nutr Res. 2008;52. doi: 10.3402/fnr.v52i0.1811.PubMedUsed to support: Meta-analysis of 59 randomized trials (not CoroWise-specific): plant sterol products lowered LDL by 0.31 mmol/L versus placebo, with larger effects at higher starting LDL and in fat spreads, dressings, milk and yogurt than in juices or baked goods; a single morning dose had no significant effect.
  3. Devaraj S, Jialal I, Vega-López S. Plant sterol-fortified orange juice effectively lowers cholesterol levels in mildly hypercholesterolemic healthy individuals. Arterioscler Thromb Vasc Biol. 2004;24(3):e25-8. doi: 10.1161/01.ATV.0000120784.08823.99.PubMedUsed to support: Randomized placebo-controlled trial in 72 healthy adults with mildly high cholesterol: nonfat orange juice with 2 g a day of plant sterols for 8 weeks lowered LDL by 12.4% and apoB by 9.5%. The abstract does not name the sterol; a 2004 review in Lipids in Health and Disease identifies the juice as Minute Maid orange juice with Cargill CoroWise plant sterols. LDL is a risk marker; no outcome benefit was tested.
  4. Ras RT, Geleijnse JM, Trautwein EA. LDL-cholesterol-lowering effect of plant sterols and stanols across different dose ranges: a meta-analysis of randomised controlled studies. Br J Nutr. 2014;112(2):214-9. doi: 10.1017/S0007114514000750.PubMedUsed to support: Meta-analysis of 124 studies: plant sterol or stanol intakes of 0.6 to 3.3 g a day lowered LDL by 6 to 12% on average, rising up to about 3 g a day; sterols and stanols had comparable dose responses. Authors from Unilever R&D and Wageningen University.
  5. Food and Drug Administration. Health Claim; Phytosterols and Risk of Coronary Heart Disease (notice of enforcement discretion). Federal Register. 2012;77 FR, February 21, 2012, document 2012-3940..SourceUsed to support: Not PubMed-indexed. Recounts that the 2000 interim rule (21 CFR 101.83) covers plant sterol and stanol esters, that FDA's February 14, 2003 letter to Cargill described enforcement discretion for foods with at least 400 mg of phytosterols per serving, including free forms, and a daily intake of 800 mg, and that a 2010 proposed rule was pending; FDA extended enforcement discretion until a final rule.
  6. Berger A, Jones PJ, Abumweis SS. Plant sterols: factors affecting their efficacy and safety as functional food ingredients. Lipids Health Dis. 2004;3:5. doi: 10.1186/1476-511X-3-5.PubMedUsed to support: Narrative review of plant sterol efficacy and safety. It describes the Devaraj 2004 trial (72 adults, two 8-ounce servings a day of Minute Maid non-fat orange juice providing 2 g a day of Cargill CoroWise plant sterols for 8 weeks, LDL down 12.4%) and lists Minute Maid Heart Wise juice as containing CoroWise sterols. This is the source linking the orange juice trial to the CoroWise brand.