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

NCT07448519 | Completed

• 2 other identifiers: QMREC23.06110028205
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity & Overweight; Appetite Regulation

Keywords

Gut Hormones; GLP-1; PYY; Appetite supression; Targeted nutrient delivery; Food supplement; Colon nutrient sensing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Other Outcomes (1)

• Safety and tolerability of lower gut-targeted nutrient capsules

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

Study Arms (2)

Placebo - Colonic Delivery Capsule

PLACEBO COMPARATOR

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

Active - Colonic Delivery Capsule

ACTIVE COMPARATOR

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

Interventions

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.

Active - Colonic Delivery Capsule

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.

Placebo - Colonic Delivery Capsule

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Wingate Institute of Neurogastroenterology

London, E1 2AJ, United Kingdom

Location

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to receive either active supplement capsules or matched placebo capsules at the first study visit, followed by the alternate treatment at the second visit after a washout period. This crossover design allows within-participant comparisons of hormone responses and food intake between treatments.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: June 13, 2023
• Primary Completion: August 2, 2023
• Study Completion: August 2, 2023
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)