- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03680768
Biological Age in Health Promotion - Novel Health Technology (BATE)
Development of a New Biological Age Technology Applicable in Public Health Promotion Interventions.
Study Overview
Detailed Description
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.
Data collection: After recruitment, participants need to attend once to the laboratory, overnight fasted and without having exercised for the previous 24 hours.
All 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
-
Copenhagen, Denmark, 2200
- University of Copenhagen, Department of Biomedical Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Males and females interested in their personal health status
- Healthy males and females
Exclusion Criteria:
- Pregnancy
- Previous or current cardiovascular disease
- Use of medication that affects our measurements such as betablockers,statins or medication that affects the metabolism.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biological Age
Time Frame: Day 1
|
A composite score of ones biological state (in years)
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fitness Level
Time Frame: Day 0
|
VO2max - maximal oxygen consumption (ml/min/kg)
|
Day 0
|
Strength
Time Frame: Day 0
|
Hand grip, isometric quadriceps and biceps strength (Nm)
|
Day 0
|
Sit to Stand test
Time Frame: Day 0
|
Rise and sit from a chair as many times as possible during 1 minute (number og rises)
|
Day 0
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Central obesity
Time Frame: Day 0
|
Waist to hip ratio is measured by dividing waist circumference with hip circumference in cm.
|
Day 0
|
Weight
Time Frame: Day 0
|
measured in kilograms
|
Day 0
|
Height
Time Frame: Day 0
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measured in cm
|
Day 0
|
Body composition
Time Frame: Day 0
|
BMI (kg/m2) is calculated
|
Day 0
|
Muscle mass
Time Frame: Day 0
|
muscle mass(g) is assessed by dual energy x-ray absorptiometry (DXA) and bioimpedance
|
Day 0
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Fat mass
Time Frame: Day 0
|
fat mass(g) is assessed by DXA and bioimpedance
|
Day 0
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Fat percentage
Time Frame: Day 0
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Fat%, is assessed by DXA and bioimpedance
|
Day 0
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Lipid profile
Time Frame: Day 0
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HighDensityLipoprotein (mmol/L), LowDensityLipoprofile (mmol/L), TriGlycerides (mmol/L), FreeFattyAcids (mmol/L) and Glycerol (mmol/L) is measured in a blood sample.
|
Day 0
|
Hormones
Time Frame: Day 0
|
Sex hormones: testosteron and estradiol (nmol/L) and InsulinGrowthFactor-1 (nmol/L) and Insulin (µU/ml) ais analysed from blood samples
|
Day 0
|
Inflammatory profile
Time Frame: Day 0
|
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
|
Day 0
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Levels of glycated protein and lipids as a result of exposure of excess sugars
Time Frame: Day 0
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advanced glycation endproducts (AGE) measured in the skin
|
Day 0
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Color passport photography
Time Frame: Day 0
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Profile picture taken to assess perceived age
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Day 0
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Respirometry
Time Frame: Day 0
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forced vital capacity and forced expiratory volume at one second(L)
|
Day 0
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Blood Pressure
Time Frame: Day 0
|
Systolic and Diastolic blood pressure (mmHg)
|
Day 0
|
Blood glucose
Time Frame: Day 0
|
HbA1c and fasting glucose (mmol/L) measured from blood sample
|
Day 0
|
Blood profile
Time Frame: Day 0
|
Haematocrit and Haemoglobin (mmol/L) measured in a blood sample
|
Day 0
|
Aging biomarker
Time Frame: Day 0
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Chemokines Eotaxin (CCL11) analysed from blood samples
|
Day 0
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Youth biomarker
Time Frame: Day 0
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Growth Differential Factor (GDF-11) analysed from blood samples
|
Day 0
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jørn W Helge, Prof, Biomedicinsk Institut
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: JMIR Aging. 2022 Jun 28;5(2):e40508.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Biological Age Technology
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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