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

NCT07491835 | Completed

• 2 other identifiers: QME23.0015123456
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Obesity & Overweight; Appetite Regulation

Keywords

Food Supplement; Dose dependant effects; colon nutrient sensing; GLP-1; PYY

Outcome Measures

Primary Outcomes (1)

• Change in circulating levels of appetite-regulating gut hormones (PYY, GLP-1, ghrelin)

  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 Outcomes (2)

• Total caloric intake

  Measured at breakfast and lunch on the study visit day for each dose group

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

  30 minutes from 08:00 to 16:00 on the study visit day (17 time points)

Study Arms (2)

Medium Dose

EXPERIMENTAL

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.

Low Dose

EXPERIMENTAL

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.

Interventions

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. DIETARY_SUPPLEMENT

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.

Medium Dose

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. DIETARY_SUPPLEMENT

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.

Low Dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Wingate Institute of Neurogastroenterology

London, E1 2AJ, United Kingdom

Location

Related Publications (1)

• Peiris M, Aktar R, Reed D, Cibert-Goton V, Zdanaviciene A, Halder W, Robinow A, Corke S, Dogra H, Knowles CH, Blackshaw A. Decoy bypass for appetite suppression in obese adults: role of synergistic nutrient sensing receptors GPR84 and FFAR4 on colonic endocrine cells. Gut. 2022 May;71(5):928-937. doi: 10.1136/gutjnl-2020-323219. Epub 2021 Jun 3.

  PMID: 34083384 RESULT

MeSH Terms

Conditions

Obesity; Overweight

Interventions

perilla seed oil

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomised, double-blind, parallel-arm pilot study. A total of 20 participants with obesity (BMI 30-40 kg/m²) attended a single study visit, with 10 participants allocated to each dose arm. On the visit day, participants fasted from 20:00 h the previous evening. Capsules were administered twice on the visit day at 08:00 and 12:00, with standardised gender-adjusted meals provided (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, and hunger and appetite perception questionnaires (VAS) were completed at each time point.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 25, 2026
• Study Start: October 18, 2023
• Primary Completion: November 11, 2023
• Study Completion: November 11, 2023
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)