Biological Age Applied at Ubberup

Sponsor
University of Copenhagen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04279366
Collaborator
Technical University of Denmark (Other)
80
2
1.1
40
34.8

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyle intervention

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation and Validation of Biological Age as Health Technology
Anticipated Study Start Date :
Nov 15, 2020
Anticipated Primary Completion Date :
Dec 20, 2020
Anticipated Study Completion Date :
Dec 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Winter course

The recruited particpants attending the winter course

Behavioral: Lifestyle intervention
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.

Fall course

The recruited particpants attending the winter course

Behavioral: Lifestyle intervention
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.

Outcome Measures

Primary Outcome Measures

  1. Change in biological age [week1 and week 14]

    a composite score predicting risk of lifestyle related diseases

Secondary Outcome Measures

  1. Change in cardiorespiratory capacity [week 1 and week 14]

    VO2max maximal oxygen consumption (ml/min/kg

  2. Change in strength [week 1 and week 14]

    Hand grip, isometric quadriceps and biceps strength (Nm)

  3. Change in Sit to Stand test [week 1 and week 14]

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

  4. Change in Central obesity [week 1 and week 14]

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

  5. Change in body weight [week 1 and week 14]

    measured in kilograms

  6. Change in body composition [week 1 and week 14]

    BMI (kg/m2) is calculated

  7. Change in fat mass [week 1 and week 14]

    fat mass(g) is assessed by bioimpedance

  8. Change in fat percentage [week 1 and week 14]

    Fat%, is assessed by bioimpedance

  9. Change in muscle mass [week 1 and week 14]

    muscle mass(g) is assessed by bioimpedance

  10. Change in lipid profile [week 1 and week 14]

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

  11. Change in Inflammatory profile [week 1 and week 14]

    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

  12. Change in Blood glucose [week 1 and week 14]

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

  13. Change in Respirometry [week 1 and week 14]

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

  14. Change in Blood Pressure [week 1 and week 14]

    Systolic and Diastolic blood pressure (mmHg)

  15. Change in Advanced glycation endproducts [week 1 and week 14]

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

  16. Change in Hormones [Week 1 and week 14]

    Insulin

Other Outcome Measures

  1. Change in Metabolic Syndrome occurrence [week 1 and week 14]

    A cluster of 5 risk factors predicting risk of CVD and T2D

  2. Change in Framingham Risk Score [week 1 and week 14]

    A composite score predicting 10 years risk of future CVD

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Participation in a long course at Ubberup folk high school (12-15 weeks)

  • Age between 18-65 years

Exclusion Criteria:
  • Previous or current cardiovascular disease

  • Pregnancy

  • Conditions that prevents from performing a cycle and/or strength tests

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ubberup High School Kalundborg Danmark Denmark 4400
2 Xlab, Faculty of Health and Medical Sciences, University of Copenhagen Copenhagen Denmark 2200

Sponsors and Collaborators

  • University of Copenhagen
  • Technical University of Denmark

Investigators

  • Principal Investigator: Jørn W Helge, PhD, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jørn Wulff Helge, Proffesor Jørn Wulff Helge, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT04279366
Other Study ID Numbers:
  • UbberupBioAge
First Posted:
Feb 21, 2020
Last Update Posted:
Nov 17, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jørn Wulff Helge, Proffesor Jørn Wulff Helge, University of Copenhagen

Study Results

No Results Posted as of Nov 17, 2020