Targeted Food Supplements for Appetite Control in Adults with Obesity
This study aims to assess how targeted food supplements can affect the levels of appetite-regulating hormones, such as PYY, GLP-1, and ghrelin, in adults with obesity.
Colonic-delivered DIM + Perilla oil
+ Dietary Supplement: Colonic-delivered Placebo
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
Study start date: June 13, 2023
Actual date on which the first participant was enrolled.This study is about finding out if a special blend of food supplements, when delivered to the lower gut, can help control appetite and reduce food intake in adults with obesity. The idea is that certain nutrients can trigger the release of hormones that control appetite when they reach specific receptors in the colon. By using a new capsule design, the study aims to deliver these nutrients directly to the lower intestine. The potential outcomes of this study could lead to a non-drug approach for managing appetite in obesity, addressing a significant health challenge. The study follows a randomised, double-blind, placebo-controlled crossover design. Twenty adults with obesity will participate in two study visits, with a break in between. During each visit, they will receive either the active supplement capsules or identical placebo capsules. Blood samples will be taken at regular intervals to measure the levels of appetite-regulating hormones like PYY, GLP-1, and ghrelin. Participants will be served standard breakfast and lunch meals, and their food intake will be recorded. They will also fill out questionnaires to rate their feelings of hunger, fullness, and desire to eat. The active capsules contain diindolylmethane (DIM) and perilla oil, while the placebo capsules contain an inactive substance.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Wingate Institute of Neurogastroenterology
London, United KingdomOpen Wingate Institute of Neurogastroenterology in Google Maps