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

February 20, 2026 updated by: Kristin Verbeke, KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: small intestinal delivery capsules
Participants will ingest small intestinal delivery capsules filled with short-chain fatty acids.
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.
Experimental: Colon-delivery capsules
Participants will ingest colon-delivery capsules filled with short-chain fatty acids.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of 13C-short-chain fatty acids in blood
Time Frame: up to 12 hours
Assessed by analysing SCFA in blood samples collected at regular time points
up to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2023

Primary Completion (Actual)

March 11, 2024

Study Completion (Actual)

March 11, 2024

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • S67256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD data will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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