The Effect of Targeted Food Supplements on Gut Hormone Levels
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in circulating levels of appetite-regulating gut hormones (PYY, GLP-1, ghrelin)
Overview
Brief 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
Detailed Description
This study evaluates whether a targeted combination of naturally derived food supplements delivered to the lower gut can stimulate the release of appetite-regulating hormones and reduce food intake in adults with obesity. Specialised nutrient receptors in the colon can trigger the release of hormones involved in appetite control when activated by specific nutrients. This study tests a new capsule formulation designed to deliver selected nutrients to the lower intestine to activate these receptors.
The study uses a randomised, double-blind, placebo-controlled crossover design. Twenty adults with obesity (BMI 30-40 kg/m²) will complete two study visits separated by a washout period. At each visit, participants will receive either the active supplement formulation or matched placebo capsules.
At each visit, participants attend after an overnight fast. Blood samples are collected at regular intervals to measure circulating gut hormones including PYY, GLP-1, and ghrelin. Standardised breakfast and lunch meals with known calorie content are provided, and food intake is measured. Participants also complete repeated visual analogue scale questionnaires to assess hunger, fullness, and desire to eat.
The active formulation contains diindolylmethane (DIM) and perilla oil and is delivered using coated capsules designed for lower-gut release. The placebo capsules are visually identical and contain inactive material (methylcellulose). The crossover design allows each participant to receive both treatments for within-subject comparison.
The results will help determine whether targeted nutrient delivery to the colon can safely enhance appetite-regulating hormone responses and reduce food intake, supporting the development of non-drug approaches for appetite control in obesity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Active and placebo capsules are visually identical and presented in the same way. Participants, investigators, and study staff involved in data collection and outcome assessment remain unaware of treatment assignment. Allocation is concealed until study completion.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo - Colonic Delivery Capsule
Participants in this arm received a colonic delivery capsule containing inactive ingredients (placebo: methylcellulose). Capsules were administered prior to standard breakfast and lunch meals. Food intake, gut hormone release (PYY, GLP-1), and appetite perception (VAS) were monitored. No significant changes in caloric intake, appetite scores, or gut hormone profiles were expected from the placebo group.
Intervention: Dietary Supplement: Colonic-delivered Placebo (Dietary Supplement)
Active - Colonic Delivery Capsule
Participants in this arm received a colonic delivery capsule containing active ingredients (DIM and perilla oil). Capsules were administered prior to standard breakfast and lunch meals. Food intake, gut hormone release (PYY, GLP-1), and appetite perception (VAS) were monitored. Changes in caloric intake, appetite scores, and gut hormone profiles were expected from the active group.
Intervention: Colonic-delivered DIM + Perilla oil (Dietary Supplement)
Outcomes
Primary Outcomes
Change in circulating levels of appetite-regulating gut hormones (PYY, GLP-1, ghrelin)
Time Frame: Single day during each study visit (Visit 1 and Visit 2), with measurements every 30 minutes from 08:00 to 16:00.
Blood samples will be collected every 30 minutes from 08:00 to 16:00 on each study visit. The levels of peptide YY (PYY), glucagon-like peptide-1 (GLP-1), and ghrelin will be measured to assess the effect of targeted lower-gut nutrient delivery on appetite-regulating hormones in participants with obesity.
Secondary Outcomes
- Subjective hunger and appetite ratings using visual analogue scales (VAS)(Baseline and during each study visit (Visit 1 and Visit 2), every 30 minutes from 08:00h to 16:00h.)