Inulin,SCFA Production and Metabolic Response

Obesity Clinical Trial

Official title:

SCFA Production and Their Metabolic Effects After Inulin Ingestion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009670
• Other study ID #: Inulin and SCFA production
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: November 24, 2015
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: October 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Overweight, obese men

Exclusion Criteria:

• athletes

• diabetes mellitus

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• 13C inulin
Oral 13C inulin

Other:
• Placebo
Oral maltodextrin

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat oxidation, energy expenditure	Fat oxidation and energy expenditure are measured after inulin ingestion	1 study day for each administration	No
Secondary	Hormones that influence substrate and energy metabolism	Insulin, GLP-1, PYY will be measured in plasma after inulin ingestion	1 study day for each administration	No
Secondary	Circulating metabolites	Glucose, FFA, TG will be measured in plasma after inulin ingestion	1 study day for each administration	No
Secondary	Appetite VAS scoring	Visual Analogue Scale for hunger and appetite are completed after inulin ingestion	1 study day for each administration	No
Secondary	SCFAs	SCFA content (acetate, butyrate and propionate, unlabeled and 13C-labeled) are measured after inulin ingestion in plasma, faeces	1 study day for each administration	No
Secondary	Breath sampling 13CO2	In breath samples 13CO2 will be measured after inulin ingestion	1 study day for each administration	No