search
Back to results

Gut Flora and Lipid Metabolism

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Amoxicillin
Placebo capsule
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypercholesterolemia focused on measuring gut flora, antibiotics, lipid metabolism, LDL cholesterol

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Amoxicillin

Placebo capsules

Arm Description

Outcomes

Primary Outcome Measures

LDL-cholesterol

Secondary Outcome Measures

Lipid metabolism
Glucose metabolism

Full Information

First Posted
March 27, 2012
Last Updated
May 13, 2013
Sponsor
Maastricht University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01566266
Brief Title
Gut Flora and Lipid Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
gut flora, antibiotics, lipid metabolism, LDL cholesterol

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amoxicillin
Arm Type
Experimental
Arm Title
Placebo capsules
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
2 capsules of 250mg, 3 times per day during 1 week
Intervention Type
Drug
Intervention Name(s)
Placebo capsule
Intervention Description
2 capsules of 250mg, 3 times per day during 1 week
Primary Outcome Measure Information:
Title
LDL-cholesterol
Time Frame
Measure change between day 1 and day 8
Secondary Outcome Measure Information:
Title
Lipid metabolism
Time Frame
Measure change between day 1 and day 8 (HDL-cholesterol, triglycerides)
Title
Glucose metabolism
Time Frame
Measure change between day 1 and day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Mensink, Prof. Dr. Ir.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Gut Flora and Lipid Metabolism

We'll reach out to this number within 24 hrs