NCT02990260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 12, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

December 2, 2016

Last Update Submit

June 11, 2018

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

  • Plasma LDL cholesterol

    8 weeks

Secondary Outcomes (9)

  • LDL cholesterol

    4 weeks

  • Total cholesterol

    4 weeks, 8 weeks

  • Triglycerides

    4 weeks, 8 weeks

  • HDL cholesterol

    4 weeks, 8 weeks

  • Apo B

    4 weeks, 8 weeks

  • +4 more secondary outcomes

Study Arms (3)

Live Saccharomyces cerevisiae

ACTIVE COMPARATOR

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

Dietary Supplement: Saccharomyces cerevisiae

Yeast cell wall

ACTIVE COMPARATOR

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

Dietary Supplement: Lynside Wall Basic

Placebo

PLACEBO COMPARATOR

Maize starch and magnesium stearate. 2 capsules a day.

Dietary Supplement: Placebo

Interventions

Saccharomyces cerevisiaeDIETARY_SUPPLEMENT

Live Saccharomyces cerevisiae

Live Saccharomyces cerevisiae
Lynside Wall BasicDIETARY_SUPPLEMENT

yeast cell walls

Yeast cell wall
PlaceboDIETARY_SUPPLEMENT

Maize starch and magnesium stearate

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate hypercholesterolemia (LDL cholesterol between 1.3 and 1.9 g/L) with maximum 1 associated cardiovascular risk factor.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Pasteur de Lille

Lille, 59000, France

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 13, 2016

Study Start

December 1, 2016

Primary Completion

November 1, 2017

Study Completion

May 1, 2018

Last Updated

June 12, 2018

Record last verified: 2018-06

Locations

FR(1)