Effect of Saccharomyces Cerevisiae in LDL Cholesterol (HONEY)

June 11, 2018 updated by: Lesaffre International
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Institut Pasteur de Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma LDL cholesterol
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
LDL cholesterol
Time Frame: 4 weeks
4 weeks
Total cholesterol
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Triglycerides
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
HDL cholesterol
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Apo B
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Apo A1
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
gamma GT
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
ASAT
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
ALAT
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lesaffre International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (ESTIMATE)

December 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2018

Last Update Submitted That Met QC Criteria

June 11, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A011094-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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