Effect of Saccharomyces Cerevisiae in LDL Cholesterol | NCT02990260 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 12, 2018
Effect of Saccharomyces Cerevisiae in LDL Cholesterol
ClinicalTrials.gov ID
NCT02990260
Lead Sponsor
Lesaffre InternationalINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
201Actual
Last Update Posted
Jun 12, 2018Actual
Start Date
Dec 2016
Primary Completion Date
Nov 2017Actual
Completion Date
May 2018Actual
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.
Dyslipidemias
Saccharomyces cerevisiae
Lynside Wall Basic
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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