Gut Flora and Lipid Metabolism

Study Overview
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Brief Summary
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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
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Amoxicillin
* Drug: Placebo capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amoxicillin<br> | Drug: Amoxicillin<br>* 2 capsules of 250mg, 3 times per day during 1 week<br>|
| Placebo Comparator: Placebo capsules<br> | Drug: Placebo capsule<br>* 2 capsules of 250mg, 3 times per day during 1 week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol |  | Measure change between day 1 and day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid metabolism |  | Measure change between day 1 and day 8 (HDL-cholesterol, triglycerides) | 
| Glucose metabolism |  | Measure change between day 1 and day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut flora, antibiotics, lipid metabolism, LDL cholesterol