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Inulin,SCFA Production and Metabolic Response

NCT ID: NCT02009670

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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13C inulin

13C inulin combined with an inulin load are administered orally

Group Type EXPERIMENTAL

13C inulin

Intervention Type DIETARY_SUPPLEMENT

Oral 13C inulin

Placebo

A placebo is administered orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral maltodextrin

Interventions

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13C inulin

Oral 13C inulin

Intervention Type DIETARY_SUPPLEMENT

Placebo

Oral maltodextrin

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Overweight, obese men

Exclusion Criteria

* athletes
* diabetes mellitus
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Top Institute Food and Nutrition

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CHC Dejong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 29953876 (View on PubMed)

Other Identifiers

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Inulin and SCFA production

Identifier Type: -

Identifier Source: org_study_id