Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
201 participants
INTERVENTIONAL
2016-12-31
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Live Saccharomyces cerevisiae
Live Saccharomyces cerevisiae. 2 capsules per day (1 g).
Saccharomyces cerevisiae
Live Saccharomyces cerevisiae
Yeast cell wall
Yeast cell wall. 2 capsules a day (700 mg).
Lynside Wall Basic
yeast cell walls
Placebo
Maize starch and magnesium stearate. 2 capsules a day.
Placebo
Maize starch and magnesium stearate
Interventions
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Saccharomyces cerevisiae
Live Saccharomyces cerevisiae
Lynside Wall Basic
yeast cell walls
Placebo
Maize starch and magnesium stearate
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Lesaffre International
INDUSTRY
Responsible Party
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Locations
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Institut Pasteur de Lille
Lille, , France
Countries
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Other Identifiers
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2016-A011094-47
Identifier Type: -
Identifier Source: org_study_id
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