Gut Flora and Lipid Metabolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01566266
First received: March 27, 2012
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipid metabolism [ Time Frame: Measure change between day 1 and day 8 (HDL-cholesterol, triglycerides) ] [ Designated as safety issue: No ]
  • Glucose metabolism [ Time Frame: Measure change between day 1 and day 8 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566266

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

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01566266     History of Changes
Other Study ID Numbers: METC 12-3-011
Study First Received: March 27, 2012
Last Updated: May 13, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014