Determination of the Bioavailability of Short Chain Fatty Acids in Healthy Humans

NCT ID: NCT01757379

Last Updated: 2015-01-14

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Brief Summary

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The purpose of the study is to evaluate the bioavailability of acetate, propionate and butyrate in healthy humans using a stable isotope technology.

In addition the level of acetate, propionate and butyrate production from inulin will be determined using the principle of isotope dilution.

Detailed Description

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Conditions

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Short Chain Fatty Acids Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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13C-labeled acetate

Group Type EXPERIMENTAL

13C-labeled Acetate

Intervention Type DIETARY_SUPPLEMENT

400 mg of sodium acetate 1-13C (2 colon delivery capsules with 200 mg)

13C-labeled propionate

Group Type EXPERIMENTAL

13C-labeled propionate

Intervention Type DIETARY_SUPPLEMENT

340 mg of sodium propionate 1-13C (2 colon delivery capsules with 170 mg)

13C-labeled butyrate

Group Type EXPERIMENTAL

13C-labeled butyrate

Intervention Type DIETARY_SUPPLEMENT

990 mg sodium butyrate 1-13C (2 colon delivery capsules with 495 mg)

Inulin

Group Type EXPERIMENTAL

Inulin

Intervention Type DIETARY_SUPPLEMENT

15 g of inulin dissolved in 200 ml of water

Interventions

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13C-labeled Acetate

400 mg of sodium acetate 1-13C (2 colon delivery capsules with 200 mg)

Intervention Type DIETARY_SUPPLEMENT

13C-labeled propionate

340 mg of sodium propionate 1-13C (2 colon delivery capsules with 170 mg)

Intervention Type DIETARY_SUPPLEMENT

13C-labeled butyrate

990 mg sodium butyrate 1-13C (2 colon delivery capsules with 495 mg)

Intervention Type DIETARY_SUPPLEMENT

Inulin

15 g of inulin dissolved in 200 ml of water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Regular dietary pattern (3 meals/day)
* Age: 18-65y
* BMI: 18,5-27 kg/m2

Exclusion Criteria

* Intake of antibiotics 1 month prior to the study
* Abdominal surgery in the past, with the exception of appendectomy
* Intake of medication influencing the gastro-intestinal system 14 days prior to the study
* In treatment at a dietician
* Intake of pre- and/or probiotics
* Exposure to radioactivity 1 year prior to the study
* Serious chronic disease of the gastrointestinal tract
* Use of medication that affects the gastro-intestinal tract during the last 2 weeks prior to the study
* Pregnancy, pregnancy desire or lactation
* Blood donation during the last 3 months prior to the study
* Diabetes (type 1 or 2)
* Aberrant hemoglobin level (Hb) in blood. Normal between 14.0 and 18.0 g/dL for men and between 12.0 and 16.0 g/dL for women
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Kristin Verbeke

Professor K. Verbeke

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin Verbeke, Professor

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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KU Leuven/ UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ML5768

Identifier Type: -

Identifier Source: org_study_id

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