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

NCT06082726 | Completed DMC

• 1 other identifier: S67256
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intestinal Absorption; Short-chain Fatty Acids; Systemic Availability; Metabolism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

small intestinal delivery capsules

EXPERIMENTAL

Participants will ingest small intestinal delivery capsules filled with short-chain fatty acids.

Dietary Supplement: SCFA

Colon-delivery capsules

EXPERIMENTAL

Participants will ingest colon-delivery capsules filled with short-chain fatty acids.

Dietary Supplement: SCFA

Interventions

SCFA DIETARY_SUPPLEMENT

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.

Colon-delivery capsules; small intestinal delivery capsules

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female and male
• healthy participants
• age within 18 - 50 years
• normal BMI (18.5-25 kg/m\^2)

You may not qualify if:

• 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)

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 13, 2023
• Study Start: October 9, 2023
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: February 23, 2026

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)