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Obesity & OverweightNCT07491835

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

A study testing 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. and 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. in people with Obesity & Overweight and Appetite Regulation, run by Queen Mary University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity & Overweight, Appetite Regulation
What is being tested?
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. and 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.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited Kingdom
Study dates
18 Oct 2023to 11 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Wingate Institute of Neurogastroenterology

    London, E1 2AJ

Other trials in United Kingdom

About this study

Official title: The Effect of Nutrients on Regulating Appetite - a Dosing Study

Here are both updated sections:

Brief Summary:

Read more

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)

Read the 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.

Being tested
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 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.
Keywords
Food Supplement, Dose dependant effects, colon nutrient sensing, GLP-1, PYY
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT07491835
Study groupRoleWhat they receive
Medium DoseExperimental4 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.
Receives: 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 DoseExperimental4 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.
Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and every 30 minutes up to 8 hours on the study visit day for each dose group

Secondary outcomes (2)
  1. Total caloric intake

    Total calories consumed at breakfast and lunch meal challenge, calculated by weighing food before and after consumption

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

  2. 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 study visit.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start18 Oct 2023
  3. Primary completion11 Nov 2023
  4. Study completion11 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07491835
Sponsor's protocol ID
QME23.0015
Other IDs
123456
Status last verified
Mar 2026
First submitted
13 Mar 2026
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 34083384

Questions about this trial

What is this clinical trial studying?

A study testing 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. and 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. in people with Obesity & Overweight and Appetite Regulation, run by Queen Mary University of London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07491835, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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