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.
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
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.
- Conditions
- Obesity & Overweight, Appetite Regulation
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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 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. 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.
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)
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
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.
- First posted25 Mar 2026
- Study start18 Oct 2023
- Primary completion11 Nov 2023
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 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)
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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrients on Regulating Appetite - a Dosing Study
- ClinicalTrials.gov ID
- NCT07491835
- Acronym / sponsor ID
- QME23.0015
- Conditions
- Obesity & Overweight, Appetite Regulation
- Keywords
- Food Supplement, Dose dependant effects, colon nutrient sensing, GLP-1, PYY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 11 Nov 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 25 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.
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)
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medium Dose | Experimental | 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.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. |
| Low Dose | Experimental | 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.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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| 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. | Dietary supplement | 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.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. | Dietary supplement | Low Dose |
Primary outcome
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.
2 secondary outcomes
Total caloric intake
Time frame: 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)
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 25 Mar 2026.
- Results publication: PubMed 34083384Peiris 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.
- 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.
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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 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.