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Healthy AgingNCT04279366

Biological Age Applied at Ubberup

An observational study of Healthy Aging and Lifestyle Risk Reduction, run by University of Copenhagen at 2 sites 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

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Aging, Lifestyle Risk Reduction
What is being tested?
Lifestyle intervention
How many people
83 participants
Where
2 sitesDenmark
Study dates
15 Nov 2020to 6 Jun 2022
How long will I take part?
14 Weeks
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: adults participating and finishing the 12-14 week intensive lifestyle intervention at Ubberup folk high school.

Who may be able to join

  • Participation in a long course at Ubberup folk high school (12-15 weeks)
  • Age between 18-65 years

Who cannot join

  • Previous or current cardiovascular disease
  • Pregnancy
  • Conditions that prevents from performing a cycle and/or strength tests

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Xlab, Faculty of Health and Medical Sciences, University of Copenhagen

    Copenhagen, 2200

  • Ubberup High School

    Kalundborg, Danmark, 4400

Other trials in Denmark

About this study

Official title: Evaluation and Validation of Biological Age as Health Technology

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.

The 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.

Read the detailed description

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.

Data 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.

Being tested
Lifestyle intervention
Keywords
Individualised Health, Prediction, Risk Assessment
Medical subject headings
Risk Reduction Behavior

What participants receive

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

  • Lifestyle interventionBehavioural

    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.

Study groups in NCT04279366
Study groupRoleWhat they receive
Winter courseThe recruited particpants attending the winter course
Receives: Behavioral: Lifestyle intervention
Fall courseThe recruited particpants attending the winter course
Receives: Behavioral: Lifestyle intervention

What is being measured

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

  1. Change in biological age

    a composite score predicting risk of lifestyle related diseases

    Measured: week1 and week 14

Secondary outcomes (16)

  1. Change in cardiorespiratory capacity

    VO2max maximal oxygen consumption (ml/min/kg

    Measured: week 1 and week 14

  2. Change in strength

    Hand grip, isometric quadriceps and biceps strength (Nm)

    Measured: week 1 and week 14

  3. Change in Sit to Stand test

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

    Measured: week 1 and week 14

  4. Change in Central obesity

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

    Measured: week 1 and week 14

  5. Change in body weight

    measured in kilograms

    Measured: week 1 and week 14

  6. Change in body composition

    BMI (kg/m2) is calculated

    Measured: week 1 and week 14

  7. Change in fat mass

    fat mass(g) is assessed by bioimpedance

    Measured: week 1 and week 14

  8. Change in fat percentage

    Fat%, is assessed by bioimpedance

    Measured: week 1 and week 14

  9. Change in muscle mass

    muscle mass(g) is assessed by bioimpedance

    Measured: week 1 and week 14

  10. Change in 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: week 1 and week 14

  11. Change in Inflammatory profile

    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

    Measured: week 1 and week 14

  12. Change in Blood glucose

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

    Measured: week 1 and week 14

  13. Change in Respirometry

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

    Measured: week 1 and week 14

  14. Change in Blood Pressure

    Systolic and Diastolic blood pressure (mmHg)

    Measured: week 1 and week 14

  15. Change in Advanced glycation endproducts

    Levels of glycated protein and lipids as a result of exposure of excess sugars advanced glycation endproducts (AGE) measured in the skin

    Measured: week 1 and week 14

  16. Change in Hormones

    Insulin

    Measured: Week 1 and week 14

Timeline

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

  1. First posted21 Feb 2020
  2. Study start15 Nov 2020
  3. Primary completion6 Jun 2022
  4. Study completion6 Jun 2022

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
Prospective
Enrolment
83 participants (actual)
Target duration
14 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT04279366
Sponsor's protocol ID
UbberupBioAge
Status last verified
Feb 2024
First submitted
18 Feb 2020
Last updated
15 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hansen MT, Husted K, Modvig JL, Lange KK, Weinreich CM, Tranberg C, Romer T, Ingersen A, Dela F, Helge JW. V̇O2peak estimation in people with overweight and obesity before and after a 14-week lifestyle intervention. Int J Obes (Lond). 2025 May;49(5):864-871. doi: 10.1038/s41366-025-01713-9. Epub 2025 Jan 20.

    PubMed 39833426

  • 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 Healthy Aging and Lifestyle Risk Reduction, run by University of Copenhagen at 2 sites 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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Change in biological age (time frame: week1 and week 14). 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 NCT04279366, 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 15 Feb 2024.

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