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Inulin,SCFA Production and Metabolic Response

Primary Purpose

Type 2 Diabetes Mellitus, Obesity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
13C inulin
Placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Overweight, obese men

Exclusion Criteria:

  • athletes
  • diabetes mellitus

Sites / Locations

  • Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

13C inulin

Placebo

Arm Description

13C inulin combined with an inulin load are administered orally

A placebo is administered orally

Outcomes

Primary Outcome Measures

Fat oxidation, energy expenditure
Fat oxidation and energy expenditure are measured after inulin ingestion

Secondary Outcome Measures

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

Full Information

First Posted
December 9, 2013
Last Updated
November 24, 2015
Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT02009670
Brief Title
Inulin,SCFA Production and Metabolic Response
Official Title
SCFA Production and Their Metabolic Effects After Inulin Ingestion
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
13C inulin
Arm Type
Experimental
Arm Description
13C inulin combined with an inulin load are administered orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A placebo is administered orally
Intervention Type
Dietary Supplement
Intervention Name(s)
13C inulin
Intervention Description
Oral 13C inulin
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral maltodextrin
Primary Outcome Measure Information:
Title
Fat oxidation, energy expenditure
Description
Fat oxidation and energy expenditure are measured after inulin ingestion
Time Frame
1 study day for each administration
Secondary Outcome Measure Information:
Title
Hormones that influence substrate and energy metabolism
Description
Insulin, GLP-1, PYY will be measured in plasma after inulin ingestion
Time Frame
1 study day for each administration
Title
Circulating metabolites
Description
Glucose, FFA, TG will be measured in plasma after inulin ingestion
Time Frame
1 study day for each administration
Title
Appetite VAS scoring
Description
Visual Analogue Scale for hunger and appetite are completed after inulin ingestion
Time Frame
1 study day for each administration
Title
SCFAs
Description
SCFA content (acetate, butyrate and propionate, unlabeled and 13C-labeled) are measured after inulin ingestion in plasma, faeces
Time Frame
1 study day for each administration
Title
Breath sampling 13CO2
Description
In breath samples 13CO2 will be measured after inulin ingestion
Time Frame
1 study day for each administration

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Overweight, obese men Exclusion Criteria: athletes diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHC Dejong, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
ZIP/Postal Code
6229ER
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
29953876
Citation
van der Beek CM, Canfora EE, Kip AM, Gorissen SHM, Olde Damink SWM, van Eijk HM, Holst JJ, Blaak EE, Dejong CHC, Lenaerts K. The prebiotic inulin improves substrate metabolism and promotes short-chain fatty acid production in overweight to obese men. Metabolism. 2018 Oct;87:25-35. doi: 10.1016/j.metabol.2018.06.009. Epub 2018 Jun 25.
Results Reference
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Inulin,SCFA Production and Metabolic Response

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