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Effect of Saccharomyces Cerevisiae in LDL Cholesterol (HONEY)

Primary Purpose

Dyslipidemias

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Saccharomyces cerevisiae
Lynside Wall Basic
Placebo
Sponsored by
Lesaffre International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dyslipidemias

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institut Pasteur de Lille

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Live Saccharomyces cerevisiae

Yeast cell wall

Placebo

Arm Description

Live Saccharomyces cerevisiae. 2 capsules per day (1 g).

Yeast cell wall. 2 capsules a day (700 mg).

Maize starch and magnesium stearate. 2 capsules a day.

Outcomes

Primary Outcome Measures

Plasma LDL cholesterol

Secondary Outcome Measures

LDL cholesterol
Total cholesterol
Triglycerides
HDL cholesterol
Apo B
Apo A1
gamma GT
ASAT
ALAT

Full Information

First Posted
December 2, 2016
Last Updated
June 11, 2018
Sponsor
Lesaffre International
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1. Study Identification

Unique Protocol Identification Number
NCT02990260
Brief Title
Effect of Saccharomyces Cerevisiae in LDL Cholesterol
Acronym
HONEY
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lesaffre International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Live Saccharomyces cerevisiae
Arm Type
Active Comparator
Arm Description
Live Saccharomyces cerevisiae. 2 capsules per day (1 g).
Arm Title
Yeast cell wall
Arm Type
Active Comparator
Arm Description
Yeast cell wall. 2 capsules a day (700 mg).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maize starch and magnesium stearate. 2 capsules a day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Saccharomyces cerevisiae
Intervention Description
Live Saccharomyces cerevisiae
Intervention Type
Dietary Supplement
Intervention Name(s)
Lynside Wall Basic
Intervention Description
yeast cell walls
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maize starch and magnesium stearate
Primary Outcome Measure Information:
Title
Plasma LDL cholesterol
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
LDL cholesterol
Time Frame
4 weeks
Title
Total cholesterol
Time Frame
4 weeks, 8 weeks
Title
Triglycerides
Time Frame
4 weeks, 8 weeks
Title
HDL cholesterol
Time Frame
4 weeks, 8 weeks
Title
Apo B
Time Frame
4 weeks, 8 weeks
Title
Apo A1
Time Frame
4 weeks, 8 weeks
Title
gamma GT
Time Frame
4 weeks, 8 weeks
Title
ASAT
Time Frame
4 weeks, 8 weeks
Title
ALAT
Time Frame
4 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Institut Pasteur de Lille
City
Lille
ZIP/Postal Code
59000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Saccharomyces Cerevisiae in LDL Cholesterol

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