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Completed

NCT Number: NCT02990260

Effect of Saccharomyces Cerevisiae in LDL Cholesterol

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Pasteur de Lille

Lille, 59000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saccharomyces cerevisiae

Dietary Supplement

Live Saccharomyces cerevisiae

Lynside Wall Basic

Dietary Supplement

yeast cell walls

Placebo

Dietary Supplement

Maize starch and magnesium stearate

Primary outcomes

  1. Plasma LDL cholesterol

    Time frame: 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lesaffre International

Industry

Registry information

Acronym: HONEY

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 13, 2016
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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