Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-30 @ 8:05 PM
Study NCT ID:
NCT01389869
Status:
COMPLETED
Last Update Posted:
2013-12-09
First Post:
2011-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Appetite Regulation by Human Chemosignals From Tears and Plasma
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']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2011-07-06', 'studyFirstSubmitQcDate': '2011-07-07', 'lastUpdatePostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The degree of appetite by visual analogue scale (VAS) and the amount of food intake by standard test meals in male volunteers while sniffing tears, trickled saline (control), and postprandial and fasting plasma in random order.', 'timeFrame': 'Visual analogue scale (VAS) will be rated 10 minutes after initial sniffing of tears/plasma just before eating standard test meals. The amount of food intake will be measured by weighing the meals before and after eating.'}], 'secondaryOutcomes': [{'measure': 'Appetite regulating hormones(ghrelin, GLP-1, PYY), glucose, testosterone. Determination of tears, tickled saline, and plasma.', 'timeFrame': 'Blood samples for measuring appetite regulating hormones, glucose, testosterone will be collected at -10, 0, and 60 min.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Emotional tears', 'Postprandial plasma', 'Chemosignal', 'Obesity', 'Appetite', 'Food intake'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Obesity is closely related to metabolic diseases and its prevalence is sharply increasing. However, there is no safe and effective treatment for obesity so far, the investigators need a breakthrough idea to curtail the constant threat of obesity. It has been recently demonstrated that emotional tears of women can modify sexual responses, one of basic instincts, in men. As appetite and food intake is another basic instinct, chemosignals from tears and plasma may modify appetite and eating behavior in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman: Negative for HIV, Syphilis (VDRL), and Hepatitis B and C\n* Man: Has a body mass index (BMI) of 18.5 kg/m2 to 27 kg/m2, inclusive.\n\nExclusion Criteria:\n\n* Woman: Has eyelids inflammation, conjunctivitis, keratitis, lacrimal duct obstruction. Has skin diseases around eyes.\n* Man: Has diabetes mellitus or dyslipidemia on medication. Received gastrointestinal surgery except appendectomy and hemorrhoidectomy.'}, 'identificationModule': {'nctId': 'NCT01389869', 'briefTitle': 'Appetite Regulation by Human Chemosignals From Tears and Plasma', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'H-1105-011-360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tears', 'description': 'Emotional tears of female volunteers while watching sad video clips', 'interventionNames': ['Biological: Sniffing emotional tears']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': "Saline collected after being trickled down women's skin below eyes like tears", 'interventionNames': ['Biological: Sniffing trickled saline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Fasting', 'description': 'Their own overnight fasting plasma of male volunteers', 'interventionNames': ['Biological: Sniffing fasting plasma']}, {'type': 'EXPERIMENTAL', 'label': 'Prandial', 'description': 'Their own postprandial plasma of male volunteers', 'interventionNames': ['Biological: Sniffing postprandial plasma']}], 'interventions': [{'name': 'Sniffing emotional tears', 'type': 'BIOLOGICAL', 'otherNames': ['Emotional tears'], 'description': 'A band-aid soaked 100μl of emotional tears will be applied just below nostrils.', 'armGroupLabels': ['Tears']}, {'name': 'Sniffing trickled saline', 'type': 'BIOLOGICAL', 'otherNames': ['Trickled saline'], 'description': 'A band-aid soaked 100μl of trickled saline will be applied just below nostrils.', 'armGroupLabels': ['Saline']}, {'name': 'Sniffing fasting plasma', 'type': 'BIOLOGICAL', 'otherNames': ['Fasting plasma'], 'description': 'A band-aid soaked 100μl of own fasting plasma will be applied just below nostrils.', 'armGroupLabels': ['Fasting']}, {'name': 'Sniffing postprandial plasma', 'type': 'BIOLOGICAL', 'otherNames': ['Postprandial plasma'], 'description': 'A band-aid soaked 100μl of own postprandial plasma will be applied just below nostrils.', 'armGroupLabels': ['Prandial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young Min Cho, MD, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Seoul National University', 'investigatorFullName': 'Young Min Cho', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}