Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 7:04 PM
Study NCT ID:
NCT05472168
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2022-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Olfactory Odour StimulatioN on Energy EXpenditure
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Energy Expenditure', 'timeFrame': '6 hours', 'description': 'change in energy expenditure as assessed via calorimetry after olfactory stimulation with different odours.'}], 'secondaryOutcomes': [{'measure': 'Energy Expenditure, Additional Odours', 'timeFrame': '6 hours', 'description': 'Change in energy expenditure as assessed via calorimetry after olfactory stimulation with Different odours'}, {'measure': 'Heart Rate', 'timeFrame': '6 hours', 'description': 'change in heart rate variability upon olfactory stimulation with different odors as assessed via continuous ECG'}, {'measure': 'Blood Pressure', 'timeFrame': '6 hours', 'description': 'Change in blood pressure upon olfactory stimulation with different odors as assessed via a blood pressure cuff at the upper arm according to Riva Rocci'}, {'measure': 'Metabolic Parameters', 'timeFrame': '6 hours', 'description': 'Change in metabolic blood parameters upon acute olfactory stimulation with different odours'}, {'measure': 'Glucose Levels', 'timeFrame': '6 hours', 'description': 'change in interstitial fluid glucose levels upon olfactory stimulation with different odours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'In this preliminary short-term study it is investigated, whether a short olfactory stimulation with distinct odours impacts energy expenditure in patients with obesity and lean patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age 18-55 years\n\n * Obesity (BMI ≥30 kg/m2) and Lean (BMI 18-25 kg/m2)\n * Written informed consent\n * Normosmia (defined by sniffing Sticks test)\n\nExclusion Criteria:\n\n* • Chronic or acute sinusitis\n\n * Surgical intervention of the nasal cavity or the paranasal sinus\n * Known allergy to odors used in the study\n * Smokers\n * Current illicit drug abuse including daily marijuana and cannabidiol (CBD) consumption (alcohol ≤2 drinks per day allowed)\n * Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)\n * Diabetes mellitus\n * Treatment with insulin sensitizing drugs including Glucagon-like Peptide (GLP)-1 analogues within the last 3 months\n * History of neurodegenerative diseases, severe head trauma\n * Severe renal impairment (e.g. estimated glomerular filtration rate \\<30 ml/min/m2)\n * Known liver cirrhosis or other severe liver impairment\n * Use of any kind of decongestant more than twice a week\n * Use of cortisone-containing nasal spray within the last 3 months\n * Acute upper respiratory tract infection\n * Uncontrolled dysthyroidism\n * Uncontrolled hypertension\n * Regular use of psychopharmaceutic drugs\n * Study participants aims to start a new diet or exercise program during the study\n * Bariatric surgery\n * Pregnancy/Lactation\n * Onset of climacteric symptoms within one year (e.g. hot flashes and/or diaphoresis) OR initiation of hormonal replacement therapy in the last three months\n * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.\n * Participation in an interventional study within the last 3 months'}, 'identificationModule': {'nctId': 'NCT05472168', 'acronym': 'SNEEX', 'briefTitle': 'Impact of Olfactory Odour StimulatioN on Energy EXpenditure', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'SNEEX - Impact of Olfactory Odour StimulatioN on Energy EXpenditure', 'orgStudyIdInfo': {'id': 'Timper_Olfactory_2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Obese', 'description': 'Age 18-55 years Obesity (BMI ≥30 kg/m2) Written informed consent Normosmia (defined by sniffing Sticks test)', 'interventionNames': ['Other: Olfactory Stimulation']}, {'type': 'OTHER', 'label': 'Lean', 'description': 'Age 18-55 years Lean (BMI 18-25 kg/m2) Written informed consent Normosmia (defined by sniffing Sticks test)', 'interventionNames': ['Other: Olfactory Stimulation']}], 'interventions': [{'name': 'Olfactory Stimulation', 'type': 'OTHER', 'otherNames': ['Different odours'], 'description': 'Participants are exposed to different odours and energy expenditure is assessed via indirect calorimetry.', 'armGroupLabels': ['Lean', 'Obese']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Katharina Timper, Prof.Dr.med.', 'role': 'CONTACT', 'email': 'katharina.timper@usb.ch', 'phone': '+41 61 328 57 42'}, {'name': 'Anouk Hoogkamer', 'role': 'CONTACT', 'email': 'anouklisa.hoogkamer@usb.ch', 'phone': '+41 61 328 55 20'}, {'name': 'Katharina Timper, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Prof. Dr. med.', 'investigatorFullName': 'Katharina Timper', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}