CompletedNot Applicable

Colonic Delivery of DIM and Perilla Oil on Gut Hormones and Food Intake in Obesity

United Kingdom20 participantsStarted 2023-06-13

Plain-language summary

The goal of this clinical trial is to learn whether targeted food supplement capsules that release nutrients in the lower gut can increase appetite-regulating gut hormones and reduce food intake in adults with obesity. The main questions it aims to answer are: * Does the targeted supplement increase blood levels of appetite-related gut hormones such as PYY and GLP-1? * Does the supplement reduce calorie intake at a standardised test meal compared with placebo? Researchers will compare active supplement capsules with placebo capsules (inactive look-alike capsules) to see whether the supplement changes hormone levels and food intake. Participants will: * Attend two study visits after an overnight fast * Take supplement capsules or placebo capsules in random order * Provide repeated blood samples during each study visit * Complete hunger and appetite rating questionnaires * Eat standardised breakfast and lunch meals so that calorie intake can be measured

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Obese but otherwise healthy volunteers aged between 18 and 60 years, of either sex * Body Mass Index (BMI) of 30-40 kg/m² * Agreement to eat the scheduled meals * Ability to understand the study information sheet and instructions in English, and able to provide informed consent Exclusion Criteria: * Not meeting any of the inclusion criteria above * Major gut surgery involving removal of any part of the gastrointestinal tract * Known major bowel disease * Currently taking medication for diabetes (Type 1 or Type 2) * Currently taking medication for weight loss

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in circulating levels of appetite-regulating gut hormones (PYY, GLP-1, ghrelin)

Timeframe: Single day during each study visit (Visit 1 and Visit 2), with measurements every 30 minutes from 08:00 to 16:00.

Trial details

NCT IDNCT07448519

SponsorQueen Mary University of London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-02

View on ClinicalTrials.gov More Obesity & Overweight trials