Gut Flora and Lipid Metabolism

NCT ID: NCT01566266

Last Updated: 2013-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-04-30

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Amoxicillin

Group Type: EXPERIMENTAL

Amoxicillin

Intervention Type: DRUG

2 capsules of 250mg, 3 times per day during 1 week

Placebo capsules

Group Type: PLACEBO_COMPARATOR

Placebo capsule

Intervention Type: DRUG

2 capsules of 250mg, 3 times per day during 1 week

Interventions

Amoxicillin

2 capsules of 250mg, 3 times per day during 1 week

Intervention Type: DRUG

Placebo capsule

2 capsules of 250mg, 3 times per day during 1 week

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Mensink, Prof. Dr. Ir.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

METC 12-3-011

Identifier Type: -

Identifier Source: org_study_id