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Completed

NCT Number: NCT06686888

The Impact of Short-Chain Fatty Acids on Gut Hormone Release After Delivery in the Small and Large Intestine of Healthy Volunteers

The goal of this crossover study is to evaluate the impact of short-chain fatty acids (SCFA) on the gut hormone release after administration in the small intestine or colon in healthy participants. The main question it aims to answer is whether the site of administration of SCFA affects the gut hormone release. On test days participants will ingest capsules filled with SCFA that are specifically delivered in the small intestine or the colon. Subsequently, blood samples are collected at regular time points.

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Key information

Conditions

Satiety Hormones Glucose Homeostasis Intestinal Absorption Metabolism Satiety and Appetite 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

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

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

On test days participants will ingest the capsules during a standard no fiber breakfast. Blood samples will be collected at regular time points for 8 hours. A visual analogue scale that questions hunger and satiety will be completed at regular time points.

microcristalline cellulose

Dietary Supplement

On test days participants will ingest the capsules during a standard no fiber breakfast. Blood samples will be collected at regular time points for 8 hours. A visual analogue scale that questions hunger and satiety will be completed at regular time points.

Primary outcomes

  1. The release of gut hormones

    Time frame: 8 hours

    Gut hormone GLP-1 (pmol/l) and PYY (pg/ml) concentrations will be quantified in the blood samples collected at different time points.

Secondary outcomes

  1. The glycemic and insulinemic response

    Time frame: 8 hours

    The glucose (mg/dl) and c-peptide (nmol/l) concentration will be determined in blood samples collected at regular time points during the test day

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

The Impact of Short-Chain Fatty Acids on the Gut Hormone Release After Delivery in the Small Intestine and Colon

Acronym: Histine

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2024
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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