Skip to main content
OpenTrials
Completed

NCT Number: NCT07448519

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity & Overweight Appetite Regulation Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wingate Institute of Neurogastroenterology

London, E1 2AJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colonic-delivered DIM + Perilla oil

Dietary Supplement

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.

Dietary Supplement: Colonic-delivered Placebo

Dietary Supplement

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.

Primary outcomes

  1. 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

  1. Subjective hunger and appetite ratings using visual analogue scales (VAS)

    Time frame: Baseline and during each study visit (Visit 1 and Visit 2), every 30 minutes from 08:00h to 16:00h.

    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.

Other outcomes

  1. Safety and tolerability of lower gut-targeted nutrient capsules

    Time frame: During each study visit and for 24 hours post-capsule ingestion.

    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.

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

The Effect of Targeted Food Supplements on Gut Hormone Levels

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.