Effect of Saccharomyces Cerevisiae in LDL Cholesterol

Dyslipidemias Clinical Trial

— HONEY  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990260
• Other study ID #: 2016-A011094-47
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: May 2018

Study information

• Verified date: June 2018
• Source: Lesaffre International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: May 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Dietary Supplement:
• Saccharomyces cerevisiae
Live Saccharomyces cerevisiae
• Lynside Wall Basic
yeast cell walls
• Placebo
Maize starch and magnesium stearate

Locations

Country	Name	City	State
France	Institut Pasteur de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Lesaffre International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma LDL cholesterol		8 weeks
Secondary	LDL cholesterol		4 weeks
Secondary	Total cholesterol		4 weeks, 8 weeks
Secondary	Triglycerides		4 weeks, 8 weeks
Secondary	HDL cholesterol		4 weeks, 8 weeks
Secondary	Apo B		4 weeks, 8 weeks
Secondary	Apo A1		4 weeks, 8 weeks
Secondary	gamma GT		4 weeks, 8 weeks
Secondary	ASAT		4 weeks, 8 weeks
Secondary	ALAT		4 weeks, 8 weeks