Gut Flora and Lipid Metabolism

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566266
• Other study ID #: METC 12-3-011
• Status: Completed
• Phase: N/A
• First received: March 27, 2012
• Last updated: May 13, 2013
• Start date: March 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Amoxicillin
2 capsules of 250mg, 3 times per day during 1 week
• Placebo capsule
2 capsules of 250mg, 3 times per day during 1 week

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-cholesterol		Measure change between day 1 and day 8	No
Secondary	Lipid metabolism		Measure change between day 1 and day 8 (HDL-cholesterol, triglycerides)	No
Secondary	Glucose metabolism		Measure change between day 1 and day 8	No