Effect of Saccharomyces Cerevisiae in LDL Cholesterol

Not Applicable

Completed

• Conditions: Dyslipidemias
• Interventions: Dietary Supplement: Saccharomyces cerevisiae; Dietary Supplement: Placebo; Dietary Supplement: Lynside Wall Basic

• Registration Number: NCT02990260
• Lead Sponsor: Lesaffre International

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-13
• Primary Completion: 2017-11
• Study Completion: 2018-05
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Live Saccharomyces cerevisiae	Saccharomyces cerevisiae	Live Saccharomyces cerevisiae. 2 capsules per day (1 g).
Placebo	Placebo	Maize starch and magnesium stearate. 2 capsules a day.
Yeast cell wall	Lynside Wall Basic	Yeast cell wall. 2 capsules a day (700 mg).

Primary Outcome Measures

Name	Time	Method
Plasma LDL cholesterol	8 weeks

Secondary Outcome Measures

Name	Time	Method
LDL cholesterol	4 weeks
Apo A1	4 weeks, 8 weeks
Triglycerides	4 weeks, 8 weeks
ALAT	4 weeks, 8 weeks
gamma GT	4 weeks, 8 weeks
ASAT	4 weeks, 8 weeks
Total cholesterol	4 weeks, 8 weeks
HDL cholesterol	4 weeks, 8 weeks
Apo B	4 weeks, 8 weeks

Trial Locations

Locations (1)

Institut Pasteur de Lille; 🇫🇷 Lille, France