Effect of Saccharomyces Cerevisiae in LDL Cholesterol

Study Overview
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Brief Summary
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The aim of the study is to evaluate the effect of the consumption of a food supplement (live saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.

Conditions
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Dyslipidemias

Intervention / Treatment
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* Dietary Supplement: Saccharomyces cerevisiae
* Dietary Supplement: Lynside Wall Basic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate hypercholesterolemia (LDL cholesterol between 1.3 and 1.9 g/L) with maximum 1 associated cardiovascular risk factor. Exclusion Criteria: Total cholesterol > 3.5 g/L (on an empty stomach) Triglycerides > 3 g/L (on an empty stomach) Familial hypercholesterolemia (IIa type) Diabete mellitus treated or not Subjects having consumed drugs known for their impact on lipid metabolism (statines, ezetimibes, colestyramin, fibrate...) in the month before beginning if the study and/or susceptible to consume such drugs during the study Subjects having consumed food supplements or functional foods known for their impact on cholesterolemia (phytosterols, phytostanols, policosanols, beta-glucans...) in the month before the study and/or susceptible to consume such products during the study Subjects having consumed probiotics food supplements in the month before the study and/or susceptible to consume such products during the study Subjects following a low diet regimen (intakes < 1500 kcal/day) in the month before the study and/or susceptible to start such a regimen during the study Food behaviour disorders diagnosed Subjects with rare serious diseases (rare digestive diseases, renal failure, cardiovascular diseases, tumor...) or having endure a serious surgery Subjects having endure bariatric surgery or having a gastric bypass in place Pregnant or lactating women Women willing a pregnancy Excessive alcohol consumption Susceptible to modify their tobacco consumption before the end of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Live Saccharomyces cerevisiae<br>Live Saccharomyces cerevisiae. 2 capsules per day (1 g). | Dietary Supplement: Saccharomyces cerevisiae<br>* Live Saccharomyces cerevisiae<br>|
| Active Comparator: Yeast cell wall<br>Yeast cell wall. 2 capsules a day (700 mg). | Dietary Supplement: Lynside Wall Basic<br>* yeast cell walls<br>|
| Placebo Comparator: Placebo<br>Maize starch and magnesium stearate. 2 capsules a day. | Dietary Supplement: Placebo<br>* Maize starch and magnesium stearate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma LDL cholesterol |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol |  | 4 weeks | 
| Total cholesterol |  | 4 weeks, 8 weeks | 
| Triglycerides |  | 4 weeks, 8 weeks | 
| HDL cholesterol |  | 4 weeks, 8 weeks | 
| Apo B |  | 4 weeks, 8 weeks | 
| Apo A1 |  | 4 weeks, 8 weeks | 
| gamma GT |  | 4 weeks, 8 weeks | 
| ASAT |  | 4 weeks, 8 weeks | 
| ALAT |  | 4 weeks, 8 weeks |