Biological Age Applied at Ubberup

Healthy Aging Clinical Trial

Official title:

Evaluation and Validation of Biological Age as Health Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04279366
• Other study ID #: UbberupBioAge
• Status: Completed
• Start date: November 15, 2020
• Est. completion date: June 6, 2022

Study information

• Verified date: February 2024
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 6, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Aging
• Lifestyle Risk Reduction

Intervention

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.

Locations

Country	Name	City	State
Denmark	Xlab, Faculty of Health and Medical Sciences, University of Copenhagen	Copenhagen
Denmark	Ubberup High School	Kalundborg	Danmark

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Metabolic Syndrome occurrence	A cluster of 5 risk factors predicting risk of CVD and T2D	week 1 and week 14
Other	Change in Framingham Risk Score	A composite score predicting 10 years risk of future CVD	week 1 and week 14
Primary	Change in biological age	a composite score predicting risk of lifestyle related diseases	week1 and week 14
Secondary	Change in cardiorespiratory capacity	VO2max maximal oxygen consumption (ml/min/kg	week 1 and week 14
Secondary	Change in strength	Hand grip, isometric quadriceps and biceps strength (Nm)	week 1 and week 14
Secondary	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
Secondary	Change in Central obesity	Waist to hip ratio is measured by dividing waist circumference with hip circumference in cm.	week 1 and week 14
Secondary	Change in body weight	measured in kilograms	week 1 and week 14
Secondary	Change in body composition	BMI (kg/m2) is calculated	week 1 and week 14
Secondary	Change in fat mass	fat mass(g) is assessed by bioimpedance	week 1 and week 14
Secondary	Change in fat percentage	Fat%, is assessed by bioimpedance	week 1 and week 14
Secondary	Change in muscle mass	muscle mass(g) is assessed by bioimpedance	week 1 and week 14
Secondary	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
Secondary	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
Secondary	Change in Blood glucose	HbA1c and fasting glucose (mmol/L) measured from blood sample	week 1 and week 14
Secondary	Change in Respirometry	forced vital capacity and forced expiratory volume at one second(L)	week 1 and week 14
Secondary	Change in Blood Pressure	Systolic and Diastolic blood pressure (mmHg)	week 1 and week 14
Secondary	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
Secondary	Change in Hormones	Insulin	Week 1 and week 14