Clinical trial NCT04279366: Biological Age Applied at Ubberup
Official title: Evaluation and Validation of Biological Age as Health Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Aging
Lifestyle Risk Reduction
Keywords: Individualised Health
Prediction
Risk Assessment
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
First posted: 2020-02-21
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults participating and finishing the 12-14 week intensive lifestyle intervention at Ubberup folk high school.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in biological age
timeFrame: week1 and week 14
Secondary outcomes:
measure: Change in cardiorespiratory capacity
timeFrame: week 1 and week 14
measure: Change in strength
timeFrame: week 1 and week 14
measure: Change in Sit to Stand test
timeFrame: week 1 and week 14
measure: Change in Central obesity
timeFrame: week 1 and week 14
measure: Change in body weight
timeFrame: week 1 and week 14
measure: Change in body composition
timeFrame: week 1 and week 14
measure: Change in fat mass
timeFrame: week 1 and week 14
measure: Change in fat percentage
timeFrame: week 1 and week 14
measure: Change in muscle mass
timeFrame: week 1 and week 14
measure: Change in lipid profile
timeFrame: week 1 and week 14
measure: Change in Inflammatory profile
timeFrame: week 1 and week 14
measure: Change in Blood glucose
timeFrame: week 1 and week 14
measure: Change in Respirometry
timeFrame: week 1 and week 14
measure: Change in Blood Pressure
timeFrame: week 1 and week 14
measure: Change in Advanced glycation endproducts
timeFrame: week 1 and week 14
measure: Change in Hormones
timeFrame: Week 1 and week 14
Other outcomes:
measure: Change in Metabolic Syndrome occurrence
timeFrame: week 1 and week 14
measure: Change in Framingham Risk Score
timeFrame: week 1 and week 14
Locations:
city: Kalundborg
country: Denmark
facility: Ubberup High School
state: Danmark
city: Copenhagen
country: Denmark
facility: Xlab, Faculty of Health and Medical Sciences, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Jørn W Helge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.