Effect of Lower Doses of Colonic Nutrient Supplementation on Appetite Hormones and Food Intake in Obese Adults

March 19, 2026 updated by: Queen Mary University of London

The Effect of Nutrients on Regulating Appetite - a Dosing Study

Here are both updated sections:

Brief Summary:

The goal of this clinical trial is to learn if two different doses of dietary supplements delivered to the lower gut can reduce appetite and food intake in obese adults (men and women aged 18-60 with a BMI of 30-40 kg/m²). The main questions it aims to answer are:

Does the dose of DIM and Perilla oil delivered to the colon affect circulating levels of appetite-suppressing hormones (PYY, GLP-1, ghrelin, GIP and 5-HT)? Does the dose of DIM and Perilla oil delivered to the colon affect total caloric food intake? Does the dose of DIM and Perilla oil delivered to the colon affect hunger and appetite perception?

Researchers will compare a medium dose (250mg DIM + 1050mg Perilla oil) to a low dose (125mg DIM + 525mg Perilla oil) to see if both doses are effective at suppressing appetite and reducing food intake.

Participants will:

Fast from 20:00 h the evening before their study visit Attend a single study visit at the Wingate Institute Clinical Trials Unit, London Take 4 specially coated capsules (targeting the lower gut) at 08:00 and again at 12:00 Have blood samples taken every 30 minutes across 17 time points to measure hormone levels Complete hunger and appetite questionnaires (VAS) every 30 minutes from 08:00 to 16:00 Eat a standardised gender-adjusted breakfast (max 903 kcal) and lunch (max 1340 kcal)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous research by the investigators demonstrated that targeting specific dietary nutrients to the lower gut (colon) activates nutrient-sensing receptors (GPR84 and GPR120/FFAR4) on enteroendocrine L-cells, triggering release of appetite-suppressing hormones including PYY and GLP-1 into the bloodstream. In a proof-of-concept study (NCT04292236), colon-targeted delivery of DIM, lauric acid, and Perilla oil at a high dose reduced food intake in obese volunteers. Subsequent laboratory work demonstrated that DIM and Perilla oil alone were sufficient to trigger hormone release, allowing removal of lauric acid to produce a simpler two-component formulation. A subsequent clinical study (QMERC23.061) confirmed that this two-component formulation at a medium dose was equally effective.

The current study aims to establish the minimum effective dose of this formulation by comparing a medium dose (250 mg DIM + 1050 mg Perilla oil) with a low dose (125 mg DIM + 525 mg Perilla oil), both delivered via GuardCap™ colon-targeted capsules (Evonik Industries, Germany) in a randomised, double-blind, parallel-arm design.

A total of 16 participants with obesity completed the study (9 female, 7 male; mean age 46 years; mean BMI 33.8 kg/m²), with 10 participants allocated per arm. On the single study visit day, participants fasted from 20:00 h the previous evening. Capsules were administered at 08:00 and again at 12:00, with standardised gender-adjusted meals provided (total 2539 kcal for males and 2180 kcal for females across breakfast and lunch combined). Blood samples were collected every 30 minutes across 17 time points to measure circulating levels of PYY, GLP-1, active ghrelin, GIP, and 5-HT. Hunger and appetite perception were assessed using visual analogue scales (VAS) at each time point. Hormone AUC and total caloric intake were compared between dose groups using Student's t-test, and VAS scores were analysed using two-way ANOVA with Sidak's multiple comparisons test.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 years or over
  • BMI 30-40 kg/m²
  • No prior bowel surgery
  • Not taking medications for Type II diabetes
  • Willing to consume standardised test meals
  • Able to understand the study information sheet and instructions in English
  • Able to provide written informed consent

Exclusion Criteria:

  • BMI outside the range of 30-40 kg/m²
  • Major gut surgery involving removal of any part of the gastrointestinal tract
  • Known major bowel disease
  • Currently taking medication for Type 1 or Type 2 diabetes
  • Currently taking medication for weight loss (e.g., semaglutide)
  • Unable to understand English or provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medium Dose
4 GuardCap™ colon-targeted capsules containing 250mg 3'3-diindolylmethane (DIM) and 1050mg Perilla oil (α-linolenic acid, ALA), administered orally twice daily at 08:00 and 12:00 on the single study visit day.
Dietary supplement: Arm 1 (Medium Dose): 250mg DIM and 1050mg Perilla oil in GuardCap™ colon-targeted capsules, activating GPR84 and FFA4 to stimulate PYY and GLP-1 release.
Arm 1 (Medium Dose): 4 GuardCap™ colon-targeted capsules containing 250mg 3'3-diindolylmethane (DIM) and 1050mg Perilla oil (α-linolenic acid, ALA), administered orally at 08:00 and 12:00 on the study visit day. DIM acts as a GPR84 agonist and Perilla oil as an FFA4 agonist on colonic enteroendocrine L-cells, producing synergistic release of appetite-suppressing hormones PYY and GLP-1. GuardCap™ coating ensures colonic-specific nutrient delivery. This medium dose is half the active dose used in NCT04292236 (500mg DIM + 2100mg Perilla oil), which previously demonstrated significant increases in circulating PYY and GLP-1 and reductions in food intake in obese volunteers.
Experimental: Low Dose
4 GuardCap™ colon-targeted capsules containing 125mg 3'3-diindolylmethane (DIM) and 525mg Perilla oil (α-linolenic acid, ALA), administered orally twice daily at 08:00 and 12:00 on the single study visit day.
Dietary supplement: Arm 2 (Low Dose): 125mg DIM and 525mg Perilla oil in GuardCap™ colon-targeted capsules, activating GPR84 and FFA4 to stimulate PYY and GLP-1 release.

Arm 2 (Low Dose):

4 GuardCap™ colon-targeted capsules containing 125mg 3'3-diindolylmethane (DIM) and 525mg Perilla oil (α-linolenic acid, ALA), administered orally at 08:00 and 12:00 on the study visit day. DIM acts as a GPR84 agonist and Perilla oil as an FFA4 agonist on colonic enteroendocrine L-cells, producing synergistic release of appetite-suppressing hormones PYY and GLP-1. GuardCap™ coating ensures colonic-specific nutrient delivery. This low dose is a quarter of the active dose used in NCT04292236, included to identify the minimum effective dose for meaningful colonic GPR84 and FFA4 activation.

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)
Time Frame: Baseline and every 30 minutes up to 8 hours on the study visit day for each dose group
Blood samples will be collected at baseline and every 30 minutes for up to 8 hours on each study visit. Circulating 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.
Baseline and every 30 minutes up to 8 hours on the study visit day for each dose group

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total caloric intake
Time Frame: Measured at breakfast and lunch on the study visit day for each dose group
Total calories consumed at breakfast and lunch meal challenge, calculated by weighing food before and after consumption
Measured at breakfast and lunch on the study visit day for each dose group
Subjective hunger and appetite ratings using visual analogue scales (VAS)
Time Frame: 30 minutes from 08:00 to 16:00 on the study visit day (17 time points)
Participants will complete hunger and satiety questionnaires using VAS at baseline (day -7) and every 30 minutes from 08:00h to 16:00h during study visit.
30 minutes from 08:00 to 16:00 on the study visit day (17 time points)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2023

Primary Completion (Actual)

November 11, 2023

Study Completion (Actual)

November 11, 2023

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QME23.0015
  • 123456 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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