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

NCT ID: NCT06686888

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-25

Study Completion Date

2025-01-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Small intestinal delivery capsules

SCFA

Group Type EXPERIMENTAL

SCFA

Intervention Type 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

SCFA

Group Type EXPERIMENTAL

SCFA

Intervention Type 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

Microcristalline cellulose

Group Type PLACEBO_COMPARATOR

microcristalline cellulose

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Kristin Verbeke

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KU Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Riet Rosseel, Msc

Role: CONTACT

Phone: +3216373428

Email: [email protected]

Facility Contacts

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Riet Rosseel, Msc

Role: primary

Kristin Verbeke, Prof

Role: backup

Other Identifiers

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S67256- study 2

Identifier Type: -

Identifier Source: org_study_id