Gut Flora and Lipid Metabolism

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01566266

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: Amoxicillin Drug: Placebo capsule	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

77 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

LDL-cholesterol [Measure change between day 1 and day 8]

Secondary Outcome Measures

Lipid metabolism [Measure change between day 1 and day 8 (HDL-cholesterol, triglycerides)]
Glucose metabolism [Measure change between day 1 and day 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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