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

Not Applicable

Completed

• Conditions: Short Chain Fatty Acids Bioavailability
• Interventions: Dietary Supplement: 13C-labeled butyrate; Dietary Supplement: Inulin; Dietary Supplement: 13C-labeled Acetate; Dietary Supplement: 13C-labeled propionate

• Registration Number: NCT01757379
• Lead Sponsor: KU Leuven

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-04
• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2012-12-21
• Study First Posted: 2012-12-28
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
13C-labeled butyrate	13C-labeled butyrate	-
Inulin	Inulin	-
13C-labeled acetate	13C-labeled Acetate	-
13C-labeled propionate	13C-labeled propionate	-

Primary Outcome Measures

Name	Time	Method
Concentrations of the short chain fatty acids (acetate, propionate and butyrate) in plasma and urine samples	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.

Trial Locations

Locations (1)

KU Leuven/ UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium