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

NCT06686888 | Completed DMC

• 1 other identifier: S67256- study 2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Satiety Hormones; Short-chain Fatty Acids; Satiety and Appetite; Intestinal Absorption; Metabolism; Glucose Homeostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The glycemic and insulinemic response

  8 hours

Study Arms (3)

Small intestinal delivery capsules

EXPERIMENTAL

SCFA

Dietary Supplement: SCFA

Colon-delivery capsules

EXPERIMENTAL

SCFA

Dietary Supplement: SCFA

placebo capsules

PLACEBO COMPARATOR

Microcristalline cellulose

Dietary Supplement: microcristalline cellulose

Interventions

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.

Colon-delivery capsules; Small intestinal delivery capsules

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.

placebo capsules

Eligibility Criteria

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

You may qualify if:

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

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: November 12, 2024
• First Posted: November 13, 2024
• Study Start: September 25, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: February 23, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)