Biological Age Applied at Ubberup

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.

Study Overview

• Status: Completed
• Conditions: Healthy Aging; Lifestyle Risk Reduction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

• Study Contact: Name: Jørn W Helge, PhD; Phone Number: 45 28757506; Email: jhelge@sund.ku.dk
• Study Contact Backup: Name: Karina LS Husted, M.Sc.; Phone Number: 45 28127945; Email: karinalu@sund.ku.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • Xlab, Faculty of Health and Medical Sciences, University of Copenhagen
  • Danmark
    • Kalundborg, Danmark, Denmark, 4400
      • Ubberup High School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

adults participating and finishing the 12-14 week intensive lifestyle intervention at Ubberup folk high school.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in biological age	a composite score predicting risk of lifestyle related diseases	week1 and week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiorespiratory capacity	VO2max maximal oxygen consumption (ml/min/kg	week 1 and week 14
Change in strength	Hand grip, isometric quadriceps and biceps strength (Nm)	week 1 and week 14
Change in Sit to Stand test	Rise and sit from a chair as many times as possible during 1 minute (number og rises)	week 1 and week 14
Change in Central obesity	Waist to hip ratio is measured by dividing waist circumference with hip circumference in cm.	week 1 and week 14
Change in body weight	measured in kilograms	week 1 and week 14
Change in body composition	BMI (kg/m2) is calculated	week 1 and week 14
Change in fat mass	fat mass(g) is assessed by bioimpedance	week 1 and week 14
Change in fat percentage	Fat%, is assessed by bioimpedance	week 1 and week 14
Change in muscle mass	muscle mass(g) is assessed by bioimpedance	week 1 and week 14
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.	week 1 and week 14
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	week 1 and week 14
Change in Blood glucose	HbA1c and fasting glucose (mmol/L) measured from blood sample	week 1 and week 14
Change in Respirometry	forced vital capacity and forced expiratory volume at one second(L)	week 1 and week 14
Change in Blood Pressure	Systolic and Diastolic blood pressure (mmHg)	week 1 and week 14
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	week 1 and week 14
Change in Hormones	Insulin	Week 1 and week 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Metabolic Syndrome occurrence	A cluster of 5 risk factors predicting risk of CVD and T2D	week 1 and week 14
Change in Framingham Risk Score	A composite score predicting 10 years risk of future CVD	week 1 and week 14

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Technical University of Denmark
• Investigators: Principal Investigator: Jørn W Helge, PhD, University of Copenhagen

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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): June 6, 2022
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Risk Assessment; Prediction; Individualised Health
• Other Study ID Numbers: UbberupBioAge

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No