Beta Glucan and Acetate Production

NCT ID: NCT03714646

Last Updated: 2020-01-13

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-05

Study Completion Date

2019-05-10

Brief Summary

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Based on our hypothesis that orally administered resistant starch and beta glucan will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:

To investigate the effects of an acute administration of inulin/beta glucan in combination with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.

Detailed Description

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Conditions

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Pre Diabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

isocaloric maltodextrin before the CID

beta glucan

Group Type ACTIVE_COMPARATOR

beta gluten

Intervention Type DIETARY_SUPPLEMENT

12 g beta gluten there day before the CID

beta glucan and Resistant Starch

Group Type EXPERIMENTAL

beta glucan and resistant starch

Intervention Type DIETARY_SUPPLEMENT

12g per day the day before the CID Resistant starch 7.5 g

Interventions

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beta glucan and resistant starch

12g per day the day before the CID Resistant starch 7.5 g

Intervention Type DIETARY_SUPPLEMENT

Placebo

isocaloric maltodextrin before the CID

Intervention Type DIETARY_SUPPLEMENT

beta gluten

12 g beta gluten there day before the CID

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2)
* normoglycemic
* aged 30 - 65 years

OR

* overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2)
* pre-diabetes
* aged between 30 - 65 years.

Exclusion Criteria

* diabetes mellitus
* gastroenterological diseases or major abdominal surgery (allowed i.e.: ---appendectomy, cholecystectomy)
* lactose intolerance and other digestive disorders
* cardiovascular disease, cancer, liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively)
* disease with a life expectancy shorter than 5 years
* Use of antibiotics 3 months prior inclusion
* Use of probiotics or prebiotics
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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Canfora EE, Hermes GDA, Muller M, Bastings J, Vaughan EE, van Den Berg MA, Holst JJ, Venema K, Zoetendal EG, Blaak EE. Fiber mixture-specific effect on distal colonic fermentation and metabolic health in lean but not in prediabetic men. Gut Microbes. 2022 Jan-Dec;14(1):2009297. doi: 10.1080/19490976.2021.2009297.

Reference Type DERIVED
PMID: 34923911 (View on PubMed)

Other Identifiers

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NL63759.068.17

Identifier Type: -

Identifier Source: org_study_id

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