Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-01 @ 1:07 PM
Study NCT ID:
NCT03225456
Status:
UNKNOWN
Last Update Posted:
2017-07-21
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxytocin and Eating
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-18', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Taste sensitivity', 'timeFrame': '2-hour span following oxytocin administration', 'description': 'Taste thresholds for primary taste senses, measured using psychophysical staircase procedures'}, {'measure': 'Taste preference', 'timeFrame': '2-hour span following oxytocin administration', 'description': 'Measured using the positive/negative generalised Labeled Magnitude Scale used to\n\nassess pleasantness'}, {'measure': 'Value placed upon food', 'timeFrame': '2-hour span following oxytocin administration', 'description': 'Willingness to pay for food (vs non-food items) in a Becker-DeGroot-Marschak auction task'}], 'secondaryOutcomes': [{'measure': 'Subjective ratings of hunger and fullness', 'timeFrame': '2-hour span following oxytocin administration', 'description': 'Measured using 100-point Visual Analogue Scales'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['appetite regulation', 'obesity', 'oxytocin'], 'conditions': ['Weight Gain']}, 'descriptionModule': {'briefSummary': 'In this protocol, the investigators propose a randomised controlled trial to explore the effects of intra-nasal oxytocin administration on appetite regulation. The investigators will run a cross-over design with 60 healthy adult men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gender: Male\n* Age: 21-45 years\n* Normal weight: Body mass index of 18.5 to 22.9\n* Have had a stable weight for the past 3 months (less than 5kg)\n* Have regular breakfast meals (≥ 4 times a week of self-reported consumption of a breakfast meal)\n* Have habitual sleep of 6.5-8.5 hours\n* Have English as first language (or fluent in spoken and written English)\n\nExclusion Criteria:\n\n* Symptoms / history of any major medical condition, including:\n\n * Bariatric surgery or surgical obesity treatment\n * Diabetes\n * Cardiovascular disease\n * Thyroid disease\n * Anaemia\n * Psychiatric disorders\n * Eating disorders\n* Excessive exercise (running \\> 40 km or exercising \\> 10 hr in a week)\n* Currently on a special diet or trying deliberately to restrict food intake\n* Currently on a weight loss program\n* Smoking or substance abuse\n* Use of medications that can affect weight (e.g., steroids, approved weight-loss drugs)'}, 'identificationModule': {'nctId': 'NCT03225456', 'briefTitle': 'Oxytocin and Eating', 'organization': {'class': 'OTHER', 'fullName': 'Yale-NUS College'}, 'officialTitle': 'Exploring the Effects of Oxytocin on Appetite Regulation in Healthy Adult Men', 'orgStudyIdInfo': {'id': 'IG15-LR052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin', 'description': 'Participants will receive two doses of 24 IU intra-nasal oxytocin (Syntocinon) in a single session', 'interventionNames': ['Drug: Syntocinon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will received match placebo, again in two doses in a single session', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Syntocinon', 'type': 'DRUG', 'description': 'Intra-nasal oxytocin', 'armGroupLabels': ['Oxytocin']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Intra-nasal placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138527', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Yale-NUS College', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale-NUS College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Singapore General Hospital', 'class': 'OTHER'}, {'name': 'SingHealth Investigational Medicine Unit', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}