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Trial record 63 of 228 for:    yeast

Effect of Saccharomyces Cerevisiae in LDL Cholesterol (HONEY)

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ClinicalTrials.gov Identifier: NCT02990260
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Dietary Supplement: Saccharomyces cerevisiae Dietary Supplement: Lynside Wall Basic Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : December 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : May 2018


Arm Intervention/treatment
Active Comparator: Live Saccharomyces cerevisiae
Live Saccharomyces cerevisiae. 2 capsules per day (1 g).
Dietary Supplement: Saccharomyces cerevisiae
Live Saccharomyces cerevisiae

Active Comparator: Yeast cell wall
Yeast cell wall. 2 capsules a day (700 mg).
Dietary Supplement: Lynside Wall Basic
yeast cell walls

Placebo Comparator: Placebo
Maize starch and magnesium stearate. 2 capsules a day.
Dietary Supplement: Placebo
Maize starch and magnesium stearate




Primary Outcome Measures :
  1. Plasma LDL cholesterol [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. LDL cholesterol [ Time Frame: 4 weeks ]
  2. Total cholesterol [ Time Frame: 4 weeks, 8 weeks ]
  3. Triglycerides [ Time Frame: 4 weeks, 8 weeks ]
  4. HDL cholesterol [ Time Frame: 4 weeks, 8 weeks ]
  5. Apo B [ Time Frame: 4 weeks, 8 weeks ]
  6. Apo A1 [ Time Frame: 4 weeks, 8 weeks ]
  7. gamma GT [ Time Frame: 4 weeks, 8 weeks ]
  8. ASAT [ Time Frame: 4 weeks, 8 weeks ]
  9. ALAT [ Time Frame: 4 weeks, 8 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990260


Locations
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France
Institut Pasteur de Lille
Lille, France, 59000
Sponsors and Collaborators
Lesaffre International

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Responsible Party: Lesaffre International
ClinicalTrials.gov Identifier: NCT02990260     History of Changes
Other Study ID Numbers: 2016-A011094-47
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases