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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kristin Verbeke, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01757379
First received: December 21, 2012
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Short Chain Fatty Acids Bioavailability
Dietary Supplement: 13C-labeled Acetate
Dietary Supplement: 13C-labeled propionate
Dietary Supplement: 13C-labeled butyrate
Dietary Supplement: Inulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Evaluation of the Bioavailability and Production of Short Chain Fatty Acids in the Colon. A Stable Isotope Study in Healthy Humans.

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: April 2011
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757379

Locations
Belgium
KU Leuven/ UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Kristin Verbeke, Professor KU Leuven
  More Information

No publications provided

Responsible Party: Kristin Verbeke, Professor K. Verbeke, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01757379     History of Changes
Other Study ID Numbers: ML5768
Study First Received: December 21, 2012
Last Updated: January 10, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Katholieke Universiteit Leuven:
Short chain fatty acids
Acetate
Propionate
Butyrate
Bioavailability

ClinicalTrials.gov processed this record on August 21, 2014