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

Not Applicable

Recruiting

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

• Registration Number: NCT06686888
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-25
• Status Verified: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-12
• Study First Posted: 2024-11-13
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The release of gut hormones	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 Outcome Measures

Name	Time	Method
The glycemic and insulinemic response	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

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Belgium