Cardiosmile, Clinically tested

It has been known for over 50 years that plant sterols are the most effective natural substances for lowering plasma cholesterol and their effect on cholesterol reduction is well documented (Ras 2014, Demonty 2009).

What makes Cardiosmile Unique?

The Cardiosmile formulation is micro-dispersion of fat-free plant sterols in a solid state and a spherical configuration with extremely high surface, exposed to enhance interaction with the intestinal micelle, where it produces its effect, and unlike other plant sterols, it leads to a decrease in plasma triglyceride levels. This enhanced effect makes it a good candidate for treating dyslipidemias as it modifies the number and structure of plasma lipoproteins, which leads to less risk by minimizing the possibilities of having LDL cholesterol particles oxidize.
It is currently the only effective formulation of plant sterols providing 2 grams of fat-free sterols in one serving.

Lab tests

Clinical Background

Various randomized, placebo-controlled studies have proven that a daily intake of Cardiosmile significantly contributes to an improvement of cardiovascular health, chiefly:

Participants show good tolerance to experimental treatments and no secondary effects have been reported.

In slightly hypercholesterolemic subjects there is a reduction of LDL cholesterol by 12% in four weeks.

In metabolic syndrome patients there is a reduction of VLDL cholesterol by 10% in four weeks.

In general, all patients show an average reduction of triglycerides of 12—14% in four weeks and an improved Total to HDL cholesterol ratio.

After 6 months of consumption, a reduction in waist size in metabolic syndrome patients, particularly in women, was observed.

Women with constipation issues report improved intestinal transit.

After 6 months of consumption, an improvement in the quality of lipoproteins was observed.

There has been no negative impact on the level of vitamins or fat-soluble carotenoids compared to control.

Results Chart

(*) Shaghaghi M.A., Harding S.V., Jones P.J.H. (2014). Water dispersible plant sterol formulation shows improved effect on lipid profile compared to plant sterol esters. J. Funct. Foods, 6:280-9.
(*) Palmeiro, Y., et al. (2020). Effects of Daily Consumption of an Aqueous Dispersion of Free-Phytosterols Nanoparticles on Individuals with Metabolic Syndrome: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients, 12(8): 2392.

Ongoing Studies

Part of our philosophy is to continue working on innovation, development, and scientific evidence. Therefore, we are permanently conducting new studies to prove the effectiveness of CARDIOSMILE. If your company or research center is interested in using Cardiosmile in a clinical trial please get in touch with us to receive more information.

Therapeutic strategies

Cardiosmile may be used for people with high cholesterol levels, but also for people with an intermediate or low global cardiovascular risk who do not qualify for drug therapy, including adults and children (6+) with familial hypercholesterolemia (FH). 

(*) Atherosclerosis 232 (2014) 346-360 (https://www.atherosclerosis-journal.com/article/S0021-9150(13)00694-1/fulltext)

Combining plant sterols with statins

In addition to primary prevention among the general population, foods with added plant sterols may provide a further reduction of LDL-C for patients with dyslipidemia who have a high cardiovascular risk and who are treated with lipid-lowering medications. It is therefore relevant to define the lipid-modifying effects of plant sterols in the diet (2 to 3 g / day) combined with drug therapies to optimize their clinical use.

In clinical studies, dietary plant sterols lead to an incremental decrease of LDL-C levels by 10% to 15% when combined with treatment with statins, which is higher than 6% when the statin dosage is doubled.

(*) Gylling H., Plat J., Turley S., Ginsberg H. N., Ellegård L., Jessup W., et al. (2014). Plant sterols and plant stanols in the management of dyslipidaemia and prevention of cardiovascular disease. Atherosclerosis 232 346–360.

Lowering statin dosages due to secondary effects

It has been proven that a higher daily intake of statins has various side effects, depending on the clinical history of the consumer and the prescribed amounts. The indiscriminate use of statins has now been questioned by the medical community, the World Health Organization (WHO), and consumers themselves.

Between 10% and 25% of patients who take statins are estimated to have side effects. According to the US Food and Drug Administration (FDA), some of these effects are:

Muscle pain

Liver disorders

Diabetes

Confusion and memory loss

 Increased blood sugar

Among others

Side effects

Statin intake also has restrictions for people under 18 and pregnant women.

Recommendations suggest evaluating the combination of statins and plant sterols, whose additive effect has been widely demonstrated. The potential to reach LDL-C goals can therefore be improved, while reducing the side effects that come with high doses of statins.

Do you want to know more?

Do you want more information about CARDIOSMILE product technology & applications, clinical studies (research agreements or support in the formulation or development of a clinical study of interest), or how to be our business partner in your country to co-create the new health paradigm? Then send us a message and we'll contact you as soon as possible.