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

January 13, 2015 updated by: Kristin Verbeke, KU Leuven

Evaluation of the Bioavailability and Production of Short Chain Fatty Acids in the Colon. A Stable Isotope Study in Healthy Humans.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • KU Leuven/ UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 13C-labeled acetate
Dietary supplement: 13C-labeled Acetate
400 mg of sodium acetate 1-13C (2 colon delivery capsules with 200 mg)
Experimental: 13C-labeled propionate
Dietary supplement: 13C-labeled propionate
340 mg of sodium propionate 1-13C (2 colon delivery capsules with 170 mg)
Experimental: 13C-labeled butyrate
Dietary supplement: 13C-labeled butyrate
990 mg sodium butyrate 1-13C (2 colon delivery capsules with 495 mg)
Experimental: Inulin
Dietary supplement: Inulin
15 g of inulin dissolved in 200 ml of water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentrations of the short chain fatty acids (acetate, propionate and butyrate) in plasma and urine samples
Time Frame: 12 hours each test day and 4 test days/volunteer
Participants performed each 4 test days and they were followed each test day for 12 hours, with sample collections at regular time points. Blood samples were collected every hour during the first 4 hours and afterwards every 20 minutes during 8 hours. Urine samples were collected during 24h in different fractions: 0-4h, 4-8h, 8-12h, 12-24h.
12 hours each test day and 4 test days/volunteer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Kristin Verbeke, Professor, KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

December 21, 2012

First Posted (Estimate)

December 28, 2012

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ML5768

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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