NCT Number: NCT04279366
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.
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Notify Me18 year–65 year
All sexes
Observational
Ubberup High School, Kalundborg, Danmark, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: week1 and week 14
a composite score predicting risk of lifestyle related diseases
Time frame: week 1 and week 14
VO2max maximal oxygen consumption (ml/min/kg
Time frame: week 1 and week 14
Hand grip, isometric quadriceps and biceps strength (Nm)
Time frame: week 1 and week 14
Rise and sit from a chair as many times as possible during 1 minute (number og rises)
Time frame: week 1 and week 14
Waist to hip ratio is measured by dividing waist circumference with hip circumference in cm.
Time frame: week 1 and week 14
measured in kilograms
Time frame: week 1 and week 14
BMI (kg/m2) is calculated
Time frame: week 1 and week 14
fat mass(g) is assessed by bioimpedance
Time frame: week 1 and week 14
Fat%, is assessed by bioimpedance
Time frame: week 1 and week 14
muscle mass(g) is assessed by bioimpedance
Time frame: 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.
Time frame: 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
Time frame: week 1 and week 14
HbA1c and fasting glucose (mmol/L) measured from blood sample
Time frame: week 1 and week 14
forced vital capacity and forced expiratory volume at one second(L)
Time frame: week 1 and week 14
Systolic and Diastolic blood pressure (mmHg)
Time frame: 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
Time frame: Week 1 and week 14
Insulin
Time frame: week 1 and week 14
A cluster of 5 risk factors predicting risk of CVD and T2D
Time frame: week 1 and week 14
A composite score predicting 10 years risk of future CVD
University of Copenhagen
Other
Evaluation and Validation of Biological Age as Health Technology
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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