Short Chain Fatty Acid Metabolism and Energy Metabolism

Not Applicable

Completed

• Conditions: Obesity; Type 2 Diabetes Mellitus
• Interventions: Other: acetate or placebo infusion

• Registration Number: NCT01826162
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-18
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-08
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-08
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Overweight, obese men

Exclusion Criteria

• athletes
• diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sigmoidoscopy	acetate or placebo infusion	2 actetate concentrations and 1 placebo are administered in randomized order after clipping a catheter in the proximal colon (sigmoidoscopy)
colonoscopy	acetate or placebo infusion	2 actetate concentrations and 1 placebo are administered in randomized order after clipping a catheter in the distal colon (colonoscopy)

Primary Outcome Measures

Name	Time	Method
Fat oxidation, energy expenditure	1 study day for each administration	Fat oxidation and energy expenditure are measured during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load

Secondary Outcome Measures

Name	Time	Method
Plasma SCFA content	1 study day for each administration	Plasma SCFA content (acetate, butyrate and propionate) are measured during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load
Hormones that influence substrate and energy metabolism	1 study day for each administration	Insulin, Glucagon, GLP-1, PYY and Leptin are measured during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load
Inflammatory markers	1 study day for each administration	LBP, TNF-α, IL-6, IL-1 are measured during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load
Circulating metabolites	1 study day for each administration	Glucose, FFA, TG, Glycerol, FIAF are measured during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load
Appetite VAS scoring	1 study day for each administration	Visual Analogue Scale for hunger and appetite are filled in during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands