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

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

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.

Study Overview

• Status: Completed
• Conditions: Glucose Homeostasis; Metabolism; Intestinal Absorption; Satiety Hormones; Short-chain Fatty Acids; Satiety and Appetite
• Intervention / Treatment: Dietary supplement: SCFA; Dietary supplement: microcristalline cellulose

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Small intestinal delivery capsules; SCFA	Dietary supplement: SCFA; 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.
Experimental: Colon-delivery capsules; SCFA	Dietary supplement: SCFA; 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.
Placebo Comparator: placebo capsules; Microcristalline cellulose	Dietary supplement: microcristalline cellulose; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The release of gut hormones	Gut hormone GLP-1 (pmol/l) and PYY (pg/ml) concentrations will be quantified in the blood samples collected at different time points.	8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The glycemic and insulinemic response	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	8 hours

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: S67256- study 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD 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
• product manufactured in and exported from the U.S.: No