Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-24 @ 8:00 PM
Study NCT ID:
NCT03680768
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2018-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Age in Health Promotion - Novel Health Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample will be drawn from a vein in the elbow'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2018-09-17', 'studyFirstSubmitQcDate': '2018-09-20', 'lastUpdatePostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biological Age', 'timeFrame': 'Day 1', 'description': 'A composite score of ones biological state (in years)'}], 'secondaryOutcomes': [{'measure': 'Fitness Level', 'timeFrame': 'Day 0', 'description': 'VO2max - maximal oxygen consumption (ml/min/kg)'}, {'measure': 'Strength', 'timeFrame': 'Day 0', 'description': 'Hand grip, isometric quadriceps and biceps strength (Nm)'}, {'measure': 'Sit to Stand test', 'timeFrame': 'Day 0', 'description': 'Rise and sit from a chair as many times as possible during 1 minute (number og rises)'}, {'measure': 'Central obesity', 'timeFrame': 'Day 0', 'description': 'Waist to hip ratio is measured by dividing waist circumference with hip circumference in cm.'}, {'measure': 'Weight', 'timeFrame': 'Day 0', 'description': 'measured in kilograms'}, {'measure': 'Height', 'timeFrame': 'Day 0', 'description': 'measured in cm'}, {'measure': 'Body composition', 'timeFrame': 'Day 0', 'description': 'BMI (kg/m2) is calculated'}, {'measure': 'Muscle mass', 'timeFrame': 'Day 0', 'description': 'muscle mass(g) is assessed by dual energy x-ray absorptiometry (DXA) and bioimpedance'}, {'measure': 'Fat mass', 'timeFrame': 'Day 0', 'description': 'fat mass(g) is assessed by DXA and bioimpedance'}, {'measure': 'Fat percentage', 'timeFrame': 'Day 0', 'description': 'Fat%, is assessed by DXA and bioimpedance'}, {'measure': 'Lipid profile', 'timeFrame': 'Day 0', 'description': 'HighDensityLipoprotein (mmol/L), LowDensityLipoprofile (mmol/L), TriGlycerides (mmol/L), FreeFattyAcids (mmol/L) and Glycerol (mmol/L) is measured in a blood sample.'}, {'measure': 'Hormones', 'timeFrame': 'Day 0', 'description': 'Sex hormones: testosteron and estradiol (nmol/L) and InsulinGrowthFactor-1 (nmol/L) and Insulin (µU/ml) ais analysed from blood samples'}, {'measure': 'Inflammatory profile', 'timeFrame': 'Day 0', 'description': 'C-reactive protein mg/L, soluble urokinase plasminogen activating receptor ng/ml, InterLeukin 6,8 and 10 (pg/mL), tumor necrosis factor (pg/mL), Leptin and Adiponectin (ng/ml) is analysed from blood samples'}, {'measure': 'Levels of glycated protein and lipids as a result of exposure of excess sugars', 'timeFrame': 'Day 0', 'description': 'advanced glycation endproducts (AGE) measured in the skin'}, {'measure': 'Color passport photography', 'timeFrame': 'Day 0', 'description': 'Profile picture taken to assess perceived age'}, {'measure': 'Respirometry', 'timeFrame': 'Day 0', 'description': 'forced vital capacity and forced expiratory volume at one second(L)'}, {'measure': 'Blood Pressure', 'timeFrame': 'Day 0', 'description': 'Systolic and Diastolic blood pressure (mmHg)'}, {'measure': 'Blood glucose', 'timeFrame': 'Day 0', 'description': 'HbA1c and fasting glucose (mmol/L) measured from blood sample'}, {'measure': 'Blood profile', 'timeFrame': 'Day 0', 'description': 'Haematocrit and Haemoglobin (mmol/L) measured in a blood sample'}, {'measure': 'Aging biomarker', 'timeFrame': 'Day 0', 'description': 'Chemokines Eotaxin (CCL11) analysed from blood samples'}, {'measure': 'Youth biomarker', 'timeFrame': 'Day 0', 'description': 'Growth Differential Factor (GDF-11) analysed from blood samples'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health', 'Risk of disease', 'Prediction', 'Lifestyle'], 'conditions': ['Aging', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '35536617', 'type': 'DERIVED', 'citation': 'Husted KLS, Brink-Kjaer A, Fogelstrom M, Hulst P, Bleibach A, Henneberg KA, Sorensen HBD, Dela F, Jacobsen JCB, Helge JW. A Model for Estimating Biological Age From Physiological Biomarkers of Healthy Aging: Cross-sectional Study. JMIR Aging. 2022 May 10;5(2):e35696. doi: 10.2196/35696.'}, {'pmid': '33104001', 'type': 'DERIVED', 'citation': 'Husted KLS, Fogelstrom M, Hulst P, Brink-Kjaer A, Henneberg KA, Sorensen HBD, Dela F, Helge JW. A Biological Age Model Designed for Health Promotion Interventions: Protocol for an Interdisciplinary Study for Model Development. JMIR Res Protoc. 2020 Oct 26;9(10):e19209. doi: 10.2196/19209.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this cross-sectional study is to collect relevant molecular markers of aging and measures of physiological function. Together these biomarkers are used to develope a new Biological Age model, useful in health promotion interventions in the public health sector .', 'detailedDescription': 'Study design: 100 participants representing the healthy danish working adult population. This study seek to include both men and women equally distributed in the range of 18-65 of age.\n\nData collection: After recruitment, participants need to attend once to the laboratory, overnight fasted and without having exercised for the previous 24 hours.\n\nAll analyse are done in investigators lab (Xlab) at the department of Biomedical Sciences, Copenhagen University. When analyzes are done, the results are used in algorithm developement in cooperation with Technical university Denmark.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sample size representing the general healthy danish population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females interested in their personal health status\n* Healthy males and females\n\nExclusion Criteria:\n\n* Pregnancy\n* Previous or current cardiovascular disease\n* Use of medication that affects our measurements such as betablockers,statins or medication that affects the metabolism.'}, 'identificationModule': {'nctId': 'NCT03680768', 'acronym': 'BATE', 'briefTitle': 'Biological Age in Health Promotion - Novel Health Technology', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Development of a New Biological Age Technology Applicable in Public Health Promotion Interventions.', 'orgStudyIdInfo': {'id': 'Biological Age Technology'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Health Assessment', 'type': 'OTHER', 'description': 'The protocol includes measurements of body composition, strength test, functional and fitness test as well as biochemical measurements from blood samples and AGEreader'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University of Copenhagen, Department of Biomedical Sciences', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Jørn W Helge, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biomedicinsk Institut'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technical University of Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D., Proffesor Jørn Wulff Helge', 'investigatorFullName': 'Jørn Wulff Helge', 'investigatorAffiliation': 'University of Copenhagen'}}}}