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Completed

NCT Number: NCT06082726

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

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.

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Key information

Conditions

Systemic Availability Intestinal Absorption Metabolism Short-chain Fatty Acids

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Acronym: Sistine

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 13, 2023
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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