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

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ClinicalTrials.gov Identifier: NCT01757379
Recruitment Status : Completed
First Posted : December 28, 2012
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
Kristin Verbeke, 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.


Condition or disease Intervention/treatment Phase
Short Chain Fatty Acids Bioavailability Dietary Supplement: 13C-labeled Acetate Dietary Supplement: 13C-labeled propionate Dietary Supplement: 13C-labeled butyrate Dietary Supplement: Inulin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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.
Study Start Date : April 2011
Actual Primary Completion Date : April 2012

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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757379


Locations
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Belgium
KU Leuven/ UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Kristin Verbeke, Professor KU Leuven
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Responsible Party: Kristin Verbeke, Professor K. Verbeke, KU Leuven
ClinicalTrials.gov Identifier: NCT01757379    
Other Study ID Numbers: ML5768
First Posted: December 28, 2012    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015
Keywords provided by Kristin Verbeke, KU Leuven:
Short chain fatty acids
Acetate
Propionate
Butyrate
Bioavailability