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OpenTrials
Completed

NCT Number: NCT01757379

Determination of the Bioavailability of Short Chain Fatty Acids 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.

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Key information

Conditions

Short Chain Fatty Acids Bioavailability

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven/ UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

13C-labeled Acetate

Dietary Supplement

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

13C-labeled propionate

Dietary Supplement

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

13C-labeled butyrate

Dietary Supplement

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

Inulin

Dietary Supplement

15 g of inulin dissolved in 200 ml of water

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
First posted
Dec 28, 2012
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.