Gut Flora and Lipid Metabolism

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Placebo capsule; Drug: Amoxicillin

• Registration Number: NCT01566266
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo capsules	Placebo capsule	-
Amoxicillin	Amoxicillin	-

Primary Outcome Measures

Name	Time	Method
LDL-cholesterol	Measure change between day 1 and day 8

Secondary Outcome Measures

Name	Time	Method
Lipid metabolism	Measure change between day 1 and day 8 (HDL-cholesterol, triglycerides)
Glucose metabolism	Measure change between day 1 and day 8

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands