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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06082726
Other study ID # S67256
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 9, 2023
Est. completion date May 2024

Study information

Verified date October 2023
Source KU Leuven
Contact Riet Rosseel, Msc
Phone +3216373428
Email riet.rosseel@kuleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this crossover study is to evaluate the systemic availability of short-chain fatty acids (SCFA) that are either administered in the small intestine or the colon in healthy volunteers. The main question it aims to answer is whether the site of administration affects the amount of SCFA that reaches the systemic circulation. On two test days participants will ingest capsules filled with SCFA that are specifically delivered in the small intestine or the colon. After ingestion, blood samples will be collected at regular time points.


Recruitment information / eligibility

Status Recruiting
Enrollment 13
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - female and male - healthy participants - age within 18 - 50 years - normal BMI (18.5-25 kg/m^2) Exclusion Criteria: - Chronic gastrointestinal disorders such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, chronic constipation (less than 3 stools a week) and chronic frequent diarrhoea (more than 3 stools a day) - Previous abdominal surgery, except from appendectomy - Being on a weight loss, gluten-free, lactose-free, or vegan diet - The donation of blood during the last 3 months or suffering from low blood haemoglobin levels - The use of antibiotics or other medication that affects the gastrointestinal tract 3 months preceding the study and/or during the study - The use of prebiotics or probiotics 2 weeks preceding the study and/or during the study - Pregnancy, lactation or wish to become pregnant during the study period - Previous or current substance/alcohol dependence or abuse (> 2 units per day/14 units per week)

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
SCFA
Participants will ingest the capsules during a standard no fiber breakfast. A primed continuous infusion containing SCFA will run during the whole test day. Blood sampling will continue for 12 hours.

Locations

Country Name City State
Belgium KU Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of 13C-short-chain fatty acids in blood Assessed by analysing SCFA in blood samples collected at regular time points up to 12 hours
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