Short Chain Fatty Acids BioavailabilityNCT01757379
Determination of the Bioavailability of Short Chain Fatty Acids in Healthy Humans
A study testing 13C-labeled Acetate, 13C-labeled propionate and 13C-labeled butyrate in people with Short Chain Fatty Acids Bioavailability, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Short Chain Fatty Acids Bioavailability
- What is being tested?
- 13C-labeled Acetate, 13C-labeled propionate and 13C-labeled butyrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2011to Apr 2012
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Regular dietary pattern (3 meals/day)
- Age: 18-65y
- BMI: 18,5-27 kg/m2
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Short Chain Fatty Acids Bioavailability
- Being tested
- 13C-labeled Acetate, 13C-labeled propionate, 13C-labeled butyrate, Inulin
- Keywords
- Short chain fatty acids, Acetate, Propionate, Butyrate, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C-labeled AcetateDietary supplement
400 mg of sodium acetate 1-13C (2 colon delivery capsules with 200 mg)
13C-labeled propionateDietary supplement
340 mg of sodium propionate 1-13C (2 colon delivery capsules with 170 mg)
13C-labeled butyrateDietary supplement
990 mg sodium butyrate 1-13C (2 colon delivery capsules with 495 mg)
InulinDietary supplement
15 g of inulin dissolved in 200 ml of water
| Study group | Role | What they receive |
|---|---|---|
| 13C-labeled acetate | Experimental | Not described Receives: Dietary Supplement: 13C-labeled Acetate |
| 13C-labeled propionate | Experimental | Not described Receives: Dietary Supplement: 13C-labeled propionate |
| 13C-labeled butyrate | Experimental | Not described Receives: Dietary Supplement: 13C-labeled butyrate |
| Inulin | Experimental | Not described Receives: Dietary Supplement: Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of the short chain fatty acids (acetate, propionate and butyrate) in plasma and urine samples
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.
Measured: 12 hours each test day and 4 test days/volunteer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startApr 2011
- Primary completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Chain Fatty Acids BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
- Investigators
- Kristin Verbeke, Professor, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757379
- Sponsor's protocol ID
- ML5768
- Status last verified
- Jan 2015
- First submitted
- 21 Dec 2012
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No