Effect of Saccharomyces Cerevisiae in LDL Cholesterol (HONEY)

Lesaffre

Status: Completed

Conditions: Dyslipidemias

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Saccharomyces cerevisiae; Dietary Supplement: Lynside Wall Basic

Study type: Interventional

Funder types: Industry

Identifiers

NCT02990260

2016-A011094-47

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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201 participants in 3 patient groups, including a placebo group

Live Saccharomyces cerevisiae

Active Comparator group

Description:

Live Saccharomyces cerevisiae. 2 capsules per day (1 g).

Treatment:

Dietary Supplement: Saccharomyces cerevisiae

Yeast cell wall

Active Comparator group

Description:

Yeast cell wall. 2 capsules a day (700 mg).

Treatment:

Dietary Supplement: Lynside Wall Basic

Placebo

Placebo Comparator group

Description:

Maize starch and magnesium stearate. 2 capsules a day.

Treatment:

Dietary Supplement: Placebo