Gut Flora and Lipid Metabolism

NCT01566266 | Completed

• 1 other identifier: METC 12-3-011
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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

Keywords

gut flora; antibiotics; lipid metabolism; LDL cholesterol

Outcome Measures

Primary Outcomes (1)

• LDL-cholesterol

  Measure change between day 1 and day 8

Secondary Outcomes (2)

• Lipid metabolism

  Measure change between day 1 and day 8 (HDL-cholesterol, triglycerides)

• Glucose metabolism

  Measure change between day 1 and day 8

Study Arms (2)

Amoxicillin

EXPERIMENTAL

Drug: Amoxicillin

Placebo capsules

PLACEBO COMPARATOR

Drug: Placebo capsule

Interventions

Amoxicillin DRUG

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

Amoxicillin

Placebo capsule DRUG

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

Placebo capsules

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 18-70 years
• serum total cholesterol: 5-8mmol/L

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ronald Mensink, Prof. Dr. Ir.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

NL (1)