The Systemic Concentration of Short-Chain Fatty Acids After Delivery in the Small and Large Intestine of Healthy Volunteers

Metabolism Clinical Trial

— Sistine  

Official title:

The Systemic Availability of Short-Chain Fatty Acids After Delivery in the Small Intestine and the Colon

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082726
• Other study ID #: S67256
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Intestinal Absorption
• Metabolism

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