Obesity & OverweightNCT07448519
Colonic Delivery of DIM and Perilla Oil on Gut Hormones and Food Intake in Obesity
A study testing Colonic-delivered DIM + Perilla oil in people with Obesity & Overweight and Appetite Regulation, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. 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?
- Colonic-delivered DIM + Perilla oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2023to 2 Aug 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wingate Institute of Neurogastroenterology
London, E1 2AJ
About this study
Official title: The Effect of Targeted Food Supplements on Gut Hormone Levels
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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Obesity & Overweight, Appetite Regulation
- Being tested
- Colonic-delivered DIM + Perilla oil, Dietary Supplement: Colonic-delivered Placebo
- Keywords
- Gut Hormones, GLP-1, PYY, Appetite supression, Targeted nutrient delivery, Food supplement, Colon nutrient sensing
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic-delivered DIM + Perilla oilDietary 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 PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Colonic-delivered DIM + Perilla oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline and during each study visit (Visit 1 and Visit 2), every 30 minutes from 08:00h to 16:00h.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start13 Jun 2023
- Primary completion2 Aug 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448519
- Sponsor's protocol ID
- QMREC23.061
- Other IDs
- 10028205
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 24 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Targeted Food Supplements on Gut Hormone Levels
- ClinicalTrials.gov ID
- NCT07448519
- Acronym / sponsor ID
- QMREC23.061
- Conditions
- Obesity & Overweight, Appetite Regulation
- Keywords
- Gut Hormones, GLP-1, PYY, Appetite supression, Targeted nutrient delivery, Food supplement, Colon nutrient sensing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo - Colonic Delivery Capsule | Placebo comparator | Dietary Supplement: Dietary Supplement: Colonic-delivered PlaceboParticipants 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. |
| Active - Colonic Delivery Capsule | Active comparator | Dietary Supplement: Colonic-delivered DIM + Perilla oilParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonic-delivered DIM + Perilla oilA 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 | Active - Colonic Delivery Capsule |
| Dietary Supplement: Colonic-delivered PlaceboA 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. | Dietary supplement | Placebo - Colonic Delivery Capsule |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: 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.
Related trials for Obesity & Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonic-delivered DIM + Perilla oil 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 4 inclusion and 5 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 24 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. Some participants in this study may receive a placebo. 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: Single day during each study visit (Visit 1 and Visit 2), with measurements every 30 minutes from 08:00 to 16:00.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.