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Gut Flora and Lipid Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01566266
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : May 14, 2013
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Amoxicillin Drug: Placebo capsule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Study Start Date : March 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Amoxicillin Drug: Amoxicillin
2 capsules of 250mg, 3 times per day during 1 week

Placebo Comparator: Placebo capsules Drug: Placebo capsule
2 capsules of 250mg, 3 times per day during 1 week

Primary Outcome Measures :
  1. LDL-cholesterol [ Time Frame: Measure change between day 1 and day 8 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01566266

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Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
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Principal Investigator: Ronald Mensink, Prof. Dr. Ir. Maastricht University Medical Center
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Responsible Party: Maastricht University Medical Center Identifier: NCT01566266    
Other Study ID Numbers: METC 12-3-011
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013
Keywords provided by Maastricht University Medical Center:
gut flora
lipid metabolism
LDL cholesterol
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Anti-Bacterial Agents
Anti-Infective Agents