Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-01-04 @ 3:14 AM
Study NCT ID:
NCT06487234
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acute ObeEnd Exposure on Factors Regulating Appetite
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appetite assessment', 'timeFrame': 'Baseline to 4 hours', 'description': 'Perceived appetite as reported based on the Visual Analog Scale after a standardized mixed meal. Appetite will be assessed every 30 minutes over a 2 hour period post meal consumption, at 30, 60, 90 and 120 minutes. The Visual Analog Scale is a measure of appetite based on a 10 cm line. Participants are asked a question on how they feel about a specific aspect of appetite (e.g. hunger). Participants then place a mark on the line. A mark closer to the left indicates fullness and satiation and a mark closer to the right indicates hunger.'}, {'measure': 'Blood Hormones', 'timeFrame': 'Baseline to 4 hours', 'description': 'Fasting blood hormone levels will be measured prior to stimulation, and every 30 minutes over a 2 hour period post meal consumption, (at 30, 60, 90 and 120 minutes). Blood hormones involved in appetite and motility such as ghrelin, glucagon-like peptide 1, motilin, and pepsinogen-1 will be measured via ELISA.'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'Baseline to after stimulation, on average 1 hour', 'description': 'Blood pressure will be measured (mmHg)'}, {'measure': 'Heart rate', 'timeFrame': 'Baseline to after stimulation, on average 1 hour', 'description': 'Heart rate will be measured (beats per minute)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupuncture', 'Wearable wellness device'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'n Canada, over 60% of adults are classified as overweight and obese resulting in a public health crisis including increasing health care costs and negatively impacting the well-being of many Canadians. To overcome these barriers, the ObeEnd device, manufactured by WAT Medical Enterprise, is a new and innovative wellness technology that uses electrical pulses to stimulate acupressure point PC6 to help control appetite. PC6 stimulation could potentially modulate appetite and restore gastric dysfunction, which are important factors that contribute to obesity. If PC6 electrostimulation facilitates the normalization of appetite and restoration of gastric dysfunction in those with obesity, then the device could be a potentially helpful aid to weight loss.\n\nTo measure the change of appetite hormones and enzymes related to appetite regulation after using the ObeEnd device. The investigators hypothesize that, compared to placebo, acute electrostimulation of PC6 an acupuncture spot on the wrist for a 1 hour period will result in changes in enterogastric hormones in a direction that decreases appetite. This study will provide the first evidence of the acute effects of electrostimulation at PC6 on factors affecting body weight regulation providing insight into the utility of the ObeEnd device for weight control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with obesity (BMI\\>30kg/m2)\n* Generally healthy\n* Premenopausal females\n\nExclusion Criteria:\n\n* Past (\\<1 year) or present use of nicotine products\n* History of chronic disease or metabolic conditions\n* Females who are pregnant, less than 6 months postpartum, or breastfeeding\n* Diagnosed hepatic disease, renal impairment, uncontrolled hypothyroidism\n* Use of any medications that may affect study outcomes (e.g. hormone replacement therapy)'}, 'identificationModule': {'nctId': 'NCT06487234', 'briefTitle': 'Effect of Acute ObeEnd Exposure on Factors Regulating Appetite', 'organization': {'class': 'OTHER', 'fullName': 'Concordia University, Montreal'}, 'officialTitle': 'Determining the Physiological Mechanism Behind Acute ObeEnd Device Exposure on Factors Regulating Appetite', 'orgStudyIdInfo': {'id': '30015229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Functional band', 'interventionNames': ['Device: Functional band']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nonfunctional band', 'interventionNames': ['Device: Placebo band']}], 'interventions': [{'name': 'Functional band', 'type': 'DEVICE', 'description': 'Participants will wear the functional band for 1-hour electroacupuncture stimulation', 'armGroupLabels': ['Functional band']}, {'name': 'Placebo band', 'type': 'DEVICE', 'description': 'Participants will wear the nonfunctioning band for 1-hour with no electroacupuncture stimulation', 'armGroupLabels': ['Nonfunctional band']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4B1R6', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sylvia Santosa, PhD', 'role': 'CONTACT', 'email': 's.santosa@concordia.ca', 'phone': '514-848-2424', 'phoneExt': '5841'}], 'facility': 'Concordia University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Sylvia Santosa, PhD', 'role': 'CONTACT', 'email': 's.santosa@concordia.ca', 'phone': '514-848-2424', 'phoneExt': '5841'}, {'name': 'Anjalee I Wanasinghee', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Sylvia Santosa, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Concordia University, Montreal'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The data will be available after the study results have been accepted for publication. The data will be available for 5 y.', 'ipdSharing': 'YES', 'description': 'On request and approval by ethics', 'accessCriteria': 'On request with ethics approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Concordia University, Montreal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}