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OpenTrials
Completed

NCT Number: NCT01566266

Gut Flora and Lipid Metabolism

It is well known that metabolic responses to diet and drugs are affected by genetic and environmental factors. Still, a large part of differences in responses between individuals remains unexplained. To increase our understanding of individual differences, more and more attention is paid to the role of intestinal microbiota. Not only energy and glucose may be related to the microbiota, but also lipid metabolism. This is not surprising as lipid metabolism, glucose metabolism, and obesity are closely linked.

There is substantial evidence from in particular animal studies that the gut microbiota is related to lipid and lipoprotein metabolism. However, there is less evidence to what extent modulation of the gut microbiota changes lipid and lipoprotein metabolism in humans.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • aged between 18-70 years
  • serum total cholesterol: 5-8mmol/L

Exclusion criteria

  • serum triacylglycerol > 3.0mmol/L
  • use of oral anticonceptives
  • pregnant or breastfeeding women
  • kidney insufficiencies
  • unstable body weight
  • allergy to antibiotics
  • treatment with cholesterol-lowering drugs
  • use of medication or a medically prescribed diet
  • active cardiovascular disease
  • abuse of drugs
  • more than 21 alcohol consumptions per week for men and 14 consumptions for women
  • use of an investigational product within the previous 30 days
  • not willing to stop the consumption of products rich in plant stanol or sterol esters 3 weeks before start of the study
  • use of gastric acid inhibitors, laxantia, prebiotica, probiotica and antibiotica for at least one month before the start of the study and during the study

Treatment and study plan

Amoxicillin

Drug

2 capsules of 250mg, 3 times per day during 1 week

Placebo capsule

Drug

2 capsules of 250mg, 3 times per day during 1 week

Primary outcomes

  1. LDL-cholesterol

    Time frame: Measure change between day 1 and day 8

Secondary outcomes

  1. Lipid metabolism

    Time frame: Measure change between day 1 and day 8 (HDL-cholesterol, triglycerides)

  2. Glucose metabolism

    Time frame: Measure change between day 1 and day 8

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 29, 2012
Registry last updated
May 14, 2013

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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