Dyslipidemias
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSaccharomyces cerevisiae
Live Saccharomyces cerevisiae
DIETARY_SUPPLEMENTLynside Wall Basic
yeast cell walls
DIETARY_SUPPLEMENTPlacebo
Maize starch and magnesium stearate
Sponsors
Lesaffre International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma LDL cholesterol | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Total cholesterol | 4 weeks, 8 weeks |
| Triglycerides | 4 weeks, 8 weeks |
| HDL cholesterol | 4 weeks, 8 weeks |
| Apo B | 4 weeks, 8 weeks |
| LDL cholesterol | 4 weeks |
| gamma GT | 4 weeks, 8 weeks |
| ASAT | 4 weeks, 8 weeks |
| ALAT | 4 weeks, 8 weeks |
| Apo A1 | 4 weeks, 8 weeks |
Countries
France
Outcome results
None listed