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Gut Flora and Lipid Metabolism

This study has been completed.
Information provided by (Responsible Party):
Maastricht University Medical Center Identifier:
First received: March 27, 2012
Last updated: May 13, 2013
Last verified: May 2013

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 Intervention
Hypercholesterolemia Drug: Amoxicillin Drug: Placebo capsule

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

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

Secondary Outcome Measures:
  • Lipid metabolism [ Time Frame: Measure change between day 1 and day 8 (HDL-cholesterol, triglycerides) ]
  • Glucose metabolism [ Time Frame: Measure change between day 1 and day 8 ]

Enrollment: 77
Study Start Date: March 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01566266

Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Principal Investigator: Ronald Mensink, Prof. Dr. Ir. Maastricht University Medical Center
  More Information

Responsible Party: Maastricht University Medical Center Identifier: NCT01566266     History of Changes
Other Study ID Numbers: METC 12-3-011
Study First Received: March 27, 2012
Last Updated: May 13, 2013

Keywords provided by Maastricht University Medical Center:
gut flora
lipid metabolism
LDL cholesterol

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on August 18, 2017