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

Catholic University (KU) of Leuven

Status: Enrolling

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

Treatments: Dietary Supplement: microcristalline cellulose; Dietary Supplement: SCFA

Study type: Interventional

Funder types: Other

Identifiers

NCT06686888

S67256- study 2

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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27 participants in 3 patient groups, including a placebo group

Small intestinal delivery capsules

Experimental group

Description:

SCFA

Treatment:

Dietary Supplement: SCFA

Colon-delivery capsules

Experimental group

Description:

SCFA

Treatment:

Dietary Supplement: SCFA

placebo capsules

Placebo Comparator group

Description:

Microcristalline cellulose

Treatment:

Dietary Supplement: microcristalline cellulose