Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-15 @ 4:25 AM
Study NCT ID:
NCT04279366
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2020-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Age Applied at Ubberup
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040242', 'term': 'Risk Reduction Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample will be drawn from a vein in the elbow'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'targetDuration': '14 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Metabolic Syndrome occurrence', 'timeFrame': 'week 1 and week 14', 'description': 'A cluster of 5 risk factors predicting risk of CVD and T2D'}, {'measure': 'Change in Framingham Risk Score', 'timeFrame': 'week 1 and week 14', 'description': 'A composite score predicting 10 years risk of future CVD'}], 'primaryOutcomes': [{'measure': 'Change in biological age', 'timeFrame': 'week1 and week 14', 'description': 'a composite score predicting risk of lifestyle related diseases'}], 'secondaryOutcomes': [{'measure': 'Change in cardiorespiratory capacity', 'timeFrame': 'week 1 and week 14', 'description': 'VO2max maximal oxygen consumption (ml/min/kg'}, {'measure': 'Change in strength', 'timeFrame': 'week 1 and week 14', 'description': 'Hand grip, isometric quadriceps and biceps strength (Nm)'}, {'measure': 'Change in Sit to Stand test', 'timeFrame': 'week 1 and week 14', 'description': 'Rise and sit from a chair as many times as possible during 1 minute (number og rises)'}, {'measure': 'Change in Central obesity', 'timeFrame': 'week 1 and week 14', 'description': 'Waist to hip ratio is measured by dividing waist circumference with hip circumference in cm.'}, {'measure': 'Change in body weight', 'timeFrame': 'week 1 and week 14', 'description': 'measured in kilograms'}, {'measure': 'Change in body composition', 'timeFrame': 'week 1 and week 14', 'description': 'BMI (kg/m2) is calculated'}, {'measure': 'Change in fat mass', 'timeFrame': 'week 1 and week 14', 'description': 'fat mass(g) is assessed by bioimpedance'}, {'measure': 'Change in fat percentage', 'timeFrame': 'week 1 and week 14', 'description': 'Fat%, is assessed by bioimpedance'}, {'measure': 'Change in muscle mass', 'timeFrame': 'week 1 and week 14', 'description': 'muscle mass(g) is assessed by bioimpedance'}, {'measure': 'Change in lipid profile', 'timeFrame': 'week 1 and week 14', 'description': 'HighDensityLipoprotein (mmol/L), LowDensityLipoprofile (mmol/L), TriGlycerides (mmol/L), FreeFattyAcids (mmol/L) and Glycerol (mmol/L) is measured in a blood sample.'}, {'measure': 'Change in Inflammatory profile', 'timeFrame': 'week 1 and week 14', 'description': 'C-reactive protein mg/L, soluble urokinase plasminogen activating receptor ng/ml, InterLeukin 6 and 8 (pg/mL), tumor necrosis factor (pg/mL), Leptin and Adiponectin (ng/ml) is analysed from blood samples'}, {'measure': 'Change in Blood glucose', 'timeFrame': 'week 1 and week 14', 'description': 'HbA1c and fasting glucose (mmol/L) measured from blood sample'}, {'measure': 'Change in Respirometry', 'timeFrame': 'week 1 and week 14', 'description': 'forced vital capacity and forced expiratory volume at one second(L)'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'week 1 and week 14', 'description': 'Systolic and Diastolic blood pressure (mmHg)'}, {'measure': 'Change in Advanced glycation endproducts', 'timeFrame': 'week 1 and week 14', 'description': 'Levels of glycated protein and lipids as a result of exposure of excess sugars advanced glycation endproducts (AGE) measured in the skin'}, {'measure': 'Change in Hormones', 'timeFrame': 'Week 1 and week 14', 'description': 'Insulin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Individualised Health', 'Prediction', 'Risk Assessment'], 'conditions': ['Healthy Aging', 'Lifestyle Risk Reduction']}, 'referencesModule': {'references': [{'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': 'In a previous study the investigators have developed a novel biological age model. Assessing biological age is the assessment of the present health status and functional capacity/physiological reserve of that person in comparison with people of the same age and sex.\n\nThe aim of this study is to investigate the utility and validity of this novel biological age model designed for health promotion in real world conditions.', 'detailedDescription': 'Study design: This is a longitudinal study, where biological age assessment is conducted in the first and final week of an 11-14 week lifestyle intervention course. These courses take place at a Danish folk high school (Ubberup), which is specialized in performing intensive lifestyle interventions targeting a 10% weight loss. The intention is to include 80 adult men and women.\n\nData collection: This will take place at the facilities at Ubberup folk high school, participants being overnight fasted and without having exercised for the previous 24 hours. All analysis will be performed in investigators lab (Xlab) at the Department of Biomedical Sciences, Copenhagen University. When all samples are analysed Biological age will be calculated for each particpant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adults participating and finishing the 12-14 week intensive lifestyle intervention at Ubberup folk high school.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in a long course at Ubberup folk high school (12-15 weeks)\n* Age between 18-65 years\n\nExclusion Criteria:\n\n* Previous or current cardiovascular disease\n* Pregnancy\n* Conditions that prevents from performing a cycle and/or strength tests'}, 'identificationModule': {'nctId': 'NCT04279366', 'briefTitle': 'Biological Age Applied at Ubberup', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Evaluation and Validation of Biological Age as Health Technology', 'orgStudyIdInfo': {'id': 'UbberupBioAge'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Winter course', 'description': 'The recruited particpants attending the winter course', 'interventionNames': ['Behavioral: Lifestyle intervention']}, {'label': 'Fall course', 'description': 'The recruited particpants attending the winter course', 'interventionNames': ['Behavioral: Lifestyle intervention']}], 'interventions': [{'name': 'Lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'The 14 week courses takes place at a Danish folk high school (Ubberup), specialized in lifestyle interventions targeting a 10% weight loss. Adult individuals with obesity sign up for the course. They stay at the School for the whole course period and the total cost amounts to 300-400 Euros per week plus loss of income.', 'armGroupLabels': ['Fall course', 'Winter course']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4400', 'city': 'Kalundborg', 'state': 'Danmark', 'country': 'Denmark', 'facility': 'Ubberup High School', 'geoPoint': {'lat': 55.67954, 'lon': 11.08864}}, {'zip': '2200', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Xlab, Faculty of Health and Medical Sciences, University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Jørn W Helge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technical University of Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffesor Jørn Wulff Helge', 'investigatorFullName': 'Jørn Wulff Helge', 'investigatorAffiliation': 'University of Copenhagen'}}}}