Satiety HormonesHistineNCT06686888
The Impact of Short-Chain Fatty Acids on Gut Hormone Release After Delivery in the Small and Large Intestine of Healthy Volunteers
A study testing SCFA and microcristalline cellulose in people with Satiety Hormones and Short-chain Fatty Acids, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Satiety Hormones, Short-chain Fatty Acids, Satiety and Appetite
- What is being tested?
- SCFA and microcristalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Sep 2024to 20 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and female
- healthy
- normal BMI (18.5-25 kg/m^2)
- age within 18-50 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Short-Chain Fatty Acids on the Gut Hormone Release After Delivery in the Small Intestine and Colon
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
- Being tested
- SCFA, microcristalline cellulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCFADietary 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.
microcristalline celluloseDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Small intestinal delivery capsules | Experimental | SCFA Receives: Dietary Supplement: SCFA |
| Colon-delivery capsules | Experimental | SCFA Receives: Dietary Supplement: SCFA |
| placebo capsules | Placebo comparator | Microcristalline cellulose Receives: Dietary Supplement: microcristalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hours
Secondary outcomes (1)
The glycemic and insulinemic response
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
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start25 Sep 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Satiety HormonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686888
- Sponsor's protocol ID
- S67256- study 2
- Acronym
- Histine
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers.
Publications
Rosseel R, Vandermeulen G, Dehau T, Verbeke K. Small intestinal versus colonic short-chain fatty acid delivery drives distinct systemic concentrations and endocrine responses in humans: a randomized, crossover trial. Am J Clin Nutr. 2026 Aug 10:101470. doi: 10.1016/j.ajcnut.2026.101470. Online ahead of print.
PubMed 42575284