Inulin,SCFA Production and Metabolic Response

Not Applicable

Completed

• Conditions: Obesity; Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: 13C inulin; Other: Placebo

• Registration Number: NCT02009670
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

In this placebo controlled, double-blind, randomized crossover study the investigators will investigate in overweight/obese healthy male volunteers whether inulin administration will increase intestinal SCFA production, thereby investigating whether this will lead to acute metabolic effects.

Detailed Description

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 ingested prebiotic inulin is fermented into SCFA and these SCFA have metabolic effects.

Study Timeline

• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-12
• Study Start: 2014-02
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-10
• Last Update Submitted: 2015-11-24
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• Overweight, obese men

Exclusion Criteria

• athletes
• diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
13C inulin	13C inulin	13C inulin combined with an inulin load are administered orally
Placebo	Placebo	A placebo is administered orally

Primary Outcome Measures

Name	Time	Method
Fat oxidation, energy expenditure	1 study day for each administration	Fat oxidation and energy expenditure are measured after inulin ingestion

Secondary Outcome Measures

Name	Time	Method
Appetite VAS scoring	1 study day for each administration	Visual Analogue Scale for hunger and appetite are completed after inulin ingestion
Hormones that influence substrate and energy metabolism	1 study day for each administration	Insulin, GLP-1, PYY will be measured in plasma after inulin ingestion
SCFAs	1 study day for each administration	SCFA content (acetate, butyrate and propionate, unlabeled and 13C-labeled) are measured after inulin ingestion in plasma, faeces
Breath sampling 13CO2	1 study day for each administration	In breath samples 13CO2 will be measured after inulin ingestion
Circulating metabolites	1 study day for each administration	Glucose, FFA, TG will be measured in plasma after inulin ingestion

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands