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AgingBATENCT03680768

Biological Age in Health Promotion - Novel Health Technology

An observational study of Aging and Healthy, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 . Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Aging, Healthy
What is being tested?
Health Assessment
How many people
100 participants
Where
1 siteDenmark
Study dates
9 Oct 2018to 20 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Sample size representing the general healthy danish population

Who may be able to join

  • Males and females interested in their personal health status
  • Healthy males and females

Who cannot join

  • Pregnancy
  • Previous or current cardiovascular disease
  • Use of medication that affects our measurements such as betablockers,statins or medication that affects the metabolism.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • University of Copenhagen, Department of Biomedical Sciences

    Copenhagen, 2200

Other trials in Denmark

About this study

Official title: Development of a New Biological Age Technology Applicable in Public Health Promotion Interventions.

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 .

Read the 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.

Conditions
Aging, Healthy
Being tested
Health Assessment
Keywords
Health, Risk of disease, Prediction, Lifestyle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health AssessmentOther

    The protocol includes measurements of body composition, strength test, functional and fitness test as well as biochemical measurements from blood samples and AGEreader

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biological Age

    A composite score of ones biological state (in years)

    Measured: Day 1

Secondary outcomes (21)

  1. Fitness Level

    VO2max - maximal oxygen consumption (ml/min/kg)

    Measured: Day 0

  2. Strength

    Hand grip, isometric quadriceps and biceps strength (Nm)

    Measured: Day 0

  3. Sit to Stand test

    Rise and sit from a chair as many times as possible during 1 minute (number og rises)

    Measured: Day 0

  4. Central obesity

    Waist to hip ratio is measured by dividing waist circumference with hip circumference in cm.

    Measured: Day 0

  5. Weight

    measured in kilograms

    Measured: Day 0

  6. Height

    measured in cm

    Measured: Day 0

  7. Body composition

    BMI (kg/m2) is calculated

    Measured: Day 0

  8. Muscle mass

    muscle mass(g) is assessed by dual energy x-ray absorptiometry (DXA) and bioimpedance

    Measured: Day 0

  9. Fat mass

    fat mass(g) is assessed by DXA and bioimpedance

    Measured: Day 0

  10. Fat percentage

    Fat%, is assessed by DXA and bioimpedance

    Measured: Day 0

  11. Lipid profile

    HighDensityLipoprotein (mmol/L), LowDensityLipoprofile (mmol/L), TriGlycerides (mmol/L), FreeFattyAcids (mmol/L) and Glycerol (mmol/L) is measured in a blood sample.

    Measured: Day 0

  12. Hormones

    Sex hormones: testosteron and estradiol (nmol/L) and InsulinGrowthFactor-1 (nmol/L) and Insulin (µU/ml) ais analysed from blood samples

    Measured: Day 0

  13. Inflammatory profile

    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

    Measured: Day 0

  14. Levels of glycated protein and lipids as a result of exposure of excess sugars

    advanced glycation endproducts (AGE) measured in the skin

    Measured: Day 0

  15. Color passport photography

    Profile picture taken to assess perceived age

    Measured: Day 0

  16. Respirometry

    forced vital capacity and forced expiratory volume at one second(L)

    Measured: Day 0

  17. Blood Pressure

    Systolic and Diastolic blood pressure (mmHg)

    Measured: Day 0

  18. Blood glucose

    HbA1c and fasting glucose (mmol/L) measured from blood sample

    Measured: Day 0

  19. Blood profile

    Haematocrit and Haemoglobin (mmol/L) measured in a blood sample

    Measured: Day 0

  20. Aging biomarker

    Chemokines Eotaxin (CCL11) analysed from blood samples

    Measured: Day 0

  21. Youth biomarker

    Growth Differential Factor (GDF-11) analysed from blood samples

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2018
  2. Study start9 Oct 2018
  3. Primary completion20 Dec 2019
  4. Study completion20 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03680768
Sponsor's protocol ID
Biological Age Technology
Acronym
BATE
Status last verified
Feb 2020
First submitted
17 Sep 2018
Last updated
19 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35536617

  • 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.

    PubMed 33104001

Questions about this trial

What is this clinical trial studying?

An observational study of Aging and Healthy, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biological Age (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03680768, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.

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