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

The Effect of Targeted Food Supplements on Gut Hormone Levels

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

Study Overview

• Status: Completed
• Conditions: Appetite Regulation; Obesity & Overweight
• Intervention / Treatment: Dietary supplement: Dietary Supplement: Colonic-delivered Placebo; Dietary supplement: Colonic-delivered DIM + Perilla oil

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1 2AJ
    • Wingate Institute of Neurogastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Dietary supplement: Dietary Supplement: Colonic-delivered Placebo; A single-capsule formulation containing inactive methylcellulose, designed to reach the colon without pharmacological activity. It serves as a control to compare against active treatment, which significantly increased circulating PYY and GLP-1 and reduced caloric intake. Unlike the active formulation, the placebo does not stimulate GPR84 or FFA4, and therefore does not enhance hormone release.
Active Comparator: 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.	Dietary supplement: Colonic-delivered DIM + Perilla oil; A single-capsule formulation delivering DIM (GPR84 agonist) and Perilla oil (ALA, FFA4 agonist) to the colon, designed to stimulate satiety hormone release (PYY and GLP-1) from colonic L-cells. Active treatment significantly increased circulating PYY and GLP-1 compared to placebo, with concomitant reduction in caloric intake observed in female volunteers at lunch. The formulation allows synergistic activation of GPR84 and FFA4, improving hormone release compared to previous multi-ingredient delivery methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in circulating levels of appetite-regulating gut hormones (PYY, GLP-1, ghrelin)	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.	Single day during each study visit (Visit 1 and Visit 2), with measurements every 30 minutes from 08:00 to 16:00.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective hunger and appetite ratings using visual analogue scales (VAS)	Participants will complete hunger and satiety questionnaires using VAS at baseline (day -7) and every 30 minutes from 08:00h to 16:00h during each study visit. This will assess perceived appetite and satiety changes in response to active versus placebo supplementation.	Baseline and during each study visit (Visit 1 and Visit 2), every 30 minutes from 08:00h to 16:00h.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of lower gut-targeted nutrient capsules	Adverse events, gastrointestinal discomfort, and overall tolerability of the nutrient capsules will be monitored and recorded throughout the study to ensure safety of the intervention.	During each study visit and for 24 hours post-capsule ingestion.

Collaborators and Investigators

• Sponsor: Queen Mary University of London

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2023
• Primary Completion (Actual): August 2, 2023
• Study Completion (Actual): August 2, 2023

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: GLP-1; Food supplement; PYY; Gut Hormones; Appetite supression; Targeted nutrient delivery; Colon nutrient sensing
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; perilla seed oil
• Other Study ID Numbers: QMREC23.061; 10028205 (Other Grant/Funding Number: Innovate UK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared outside the study team due to the sensitive nature of health and dietary information collected from obese volunteers. All results will be reported in aggregated form to ensure participant confidentiality and comply with ethical standards.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No