Sistine: The Systemic Concentration of Short-Chain Fatty Acids After Delivery in the Small and Large Intestine of Healthy Volunteers

Sponsor

KU Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT06082726

Collaborator

(none)

Enrollment

Location

Arms

6.7

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this crossover study is to evaluate the systemic availability of short-chain fatty acids (SCFA) that are either administered in the small intestine or the colon in healthy volunteers. The main question it aims to answer is whether the site of administration affects the amount of SCFA that reaches the systemic circulation. On two test days participants will ingest capsules filled with SCFA that are specifically delivered in the small intestine or the colon. After ingestion, blood samples will be collected at regular time points.

Condition or Disease	Intervention/Treatment	Phase
Systemic Availability Intestinal Absorption Metabolism Short-chain Fatty Acids	Dietary Supplement: SCFA	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

The Systemic Availability of Short-Chain Fatty Acids After Delivery in the Small Intestine and the Colon

Anticipated Study Start Date :

Oct 9, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: small intestinal delivery capsules Participants will ingest small intestinal delivery capsules filled with short-chain fatty acids.	Dietary Supplement: SCFA Participants will ingest the capsules during a standard no fiber breakfast. A primed continuous infusion containing SCFA will run during the whole test day. Blood sampling will continue for 12 hours.
Experimental: Colon-delivery capsules Participants will ingest colon-delivery capsules filled with short-chain fatty acids.	Dietary Supplement: SCFA Participants will ingest the capsules during a standard no fiber breakfast. A primed continuous infusion containing SCFA will run during the whole test day. Blood sampling will continue for 12 hours.

Arm

Intervention/Treatment

Experimental: small intestinal delivery capsules

Participants will ingest small intestinal delivery capsules filled with short-chain fatty acids.

Dietary Supplement: SCFA

Participants will ingest the capsules during a standard no fiber breakfast. A primed continuous infusion containing SCFA will run during the whole test day. Blood sampling will continue for 12 hours.

Experimental: Colon-delivery capsules

Participants will ingest colon-delivery capsules filled with short-chain fatty acids.

Dietary Supplement: SCFA

Participants will ingest the capsules during a standard no fiber breakfast. A primed continuous infusion containing SCFA will run during the whole test day. Blood sampling will continue for 12 hours.

Outcome Measures

Primary Outcome Measures

Concentration of 13C-short-chain fatty acids in blood [up to 12 hours]
Assessed by analysing SCFA in blood samples collected at regular time points

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KU Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kristin Verbeke, Prof., KU Leuven

ClinicalTrials.gov Identifier:

NCT06082726

Other Study ID Numbers:

S67256

First Posted:

Oct 13, 2023

Last Update Posted:

Oct 16, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 16, 2023