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

March 27, 2012
May 13, 2013
March 2012
April 2013   (final data collection date for primary outcome measure)
LDL-cholesterol [ Time Frame: Measure change between day 1 and day 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01566266 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Gut Flora and Lipid Metabolism
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Hypercholesterolemia
  • Drug: Amoxicillin
    2 capsules of 250mg, 3 times per day during 1 week
  • Drug: Placebo capsule
    2 capsules of 250mg, 3 times per day during 1 week
  • Experimental: Amoxicillin
    Intervention: Drug: Amoxicillin
  • Placebo Comparator: Placebo capsules
    Intervention: Drug: Placebo capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01566266
METC 12-3-011
No
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Ronald Mensink, Prof. Dr. Ir. Maastricht University Medical Center
Maastricht University Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP