Completed

Differential Short Chain Fatty Acid Availability Impact on Human Metabolism

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Study Aim

This study aims to measure how your body uses fat and energy when given acetate, a type of short chain fatty acid, both while fasting and after consuming glucose.

What is being tested

acetate or placebo infusion

+ acetate or placebo infusion

Other
Who is being recruted

Body Weight+10

+ Diabetes Mellitus

+ Endocrine System Diseases

From 20 to 50 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorMaastricht University Medical Center
Last updated: September 15, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fibre, is still controversial. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. The investigators hypothesize that the differential availability of SCFA impacts human metabolism differently. In this placebo controlled, double-blind, randomized crossover pilot study the investigators will validate in overweight/obese healthy male volunteers whether rectal administration of SCFA is a good model for studying the acute metabolic effects of SCFA. For this, it will be investigated if site of administration (in distal or proximal colon) of SCFA differentially affects parameters of substrate and energy metabolism and to test the duration of short-term effects of SCFA administration.

Principal SponsorMaastricht University Medical Center
Last updated: September 15, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 20 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightDiabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweightDiabetes Mellitus, Type 2Obesity

Criteria

1 inclusion criteria required to participate
Overweight, obese men

2 exclusion criteria prevent from participating
athletes

diabetes mellitus

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
2 actetate concentrations and 1 placebo are administered in randomized order after clipping a catheter in the proximal colon (sigmoidoscopy)

Group II

Experimental
2 actetate concentrations and 1 placebo are administered in randomized order after clipping a catheter in the distal colon (colonoscopy)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Maastricht University

Maastricht, NetherlandsOpen Maastricht University in Google Maps

Maastricht University

Maastricht, Netherlands
Completed2 Study Centers