Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:43 AM
Study NCT ID:
NCT07491835
Status:
COMPLETED
Last Update Posted:
2026-03-25
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Lower Doses of Colonic Nutrient Supplementation on Appetite Hormones and Food Intake in Obese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C058216', 'term': 'perilla seed oil'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in circulating levels of appetite-regulating gut hormones (PYY, GLP-1, ghrelin)', 'timeFrame': 'Baseline and every 30 minutes up to 8 hours on the study visit day for each dose group', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Total caloric intake', 'timeFrame': 'Measured at breakfast and lunch on the study visit day for each dose group', 'description': 'Total calories consumed at breakfast and lunch meal challenge, calculated by weighing food before and after consumption'}, {'measure': 'Subjective hunger and appetite ratings using visual analogue scales (VAS)', 'timeFrame': '30 minutes from 08:00 to 16:00 on the study visit day (17 time points)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food Supplement', 'Dose dependant effects', 'colon nutrient sensing', 'GLP-1', 'PYY'], 'conditions': ['Obesity & Overweight', 'Appetite Regulation']}, 'referencesModule': {'references': [{'pmid': '34083384', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Here are both updated sections:\n\nBrief Summary:\n\nThe 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:\n\nDoes 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?\n\nResearchers 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.\n\nParticipants will:\n\nFast 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)', 'detailedDescription': "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.\n\nThe 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.\n\nA 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or over\n* BMI 30-40 kg/m²\n* No prior bowel surgery\n* Not taking medications for Type II diabetes\n* Willing to consume standardised test meals\n* Able to understand the study information sheet and instructions in English\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* BMI outside the range of 30-40 kg/m²\n* Major gut surgery involving removal of any part of the gastrointestinal tract\n* Known major bowel disease\n* Currently taking medication for Type 1 or Type 2 diabetes\n* Currently taking medication for weight loss (e.g., semaglutide)\n* Unable to understand English or provide informed consent'}, 'identificationModule': {'nctId': 'NCT07491835', 'briefTitle': 'Effect of Lower Doses of Colonic Nutrient Supplementation on Appetite Hormones and Food Intake in Obese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'The Effect of Nutrients on Regulating Appetite - a Dosing Study', 'orgStudyIdInfo': {'id': 'QME23.0015'}, 'secondaryIdInfos': [{'id': '123456', 'type': 'OTHER_GRANT', 'domain': 'Innovate UK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medium Dose', 'description': "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.", 'interventionNames': ['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.']}, {'type': 'EXPERIMENTAL', 'label': 'Low Dose', 'description': "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.", 'interventionNames': ['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': [{'name': '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.', 'type': 'DIETARY_SUPPLEMENT', 'description': "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.", 'armGroupLabels': ['Medium Dose']}, {'name': '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': 'DIETARY_SUPPLEMENT', 'description': "Arm 2 (Low Dose):\n\n4 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.", 'armGroupLabels': ['Low Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 2AJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Wingate Institute of Neurogastroenterology', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}