Physical Training Per se

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to evaluate the health benefits of physical training per se, weight loss per se and exercise-induced weight loss in young, overweight men. The investigators hypothesized that physical training would have independent effects on various health parameters (insulin sensitivity, fasting glucose and insulin, total and abdominal fat mass, waist circumference, blood pressure and key muscle proteins), and that a concomitant weight loss from physical activity would increase the effect.

Detailed Description
-----------------
At baseline, during the intervention and in the week following the intervention participants underwent a panel of tests: Cardio respiratory fitness blood pressure anthropometric measures At baseline and after the intervention a hyperinsulinemic, euglycemic clamp were performed to asses insulin sensitivity. Tissue and blood samples were also collected for further analysis: Total-protein analysis of selected proteins Fasting plasma glucose, insulin and free fatty acids

Official Title
-----------------
Physical Activity is Healthy - Effect of Weight Loss or Physical Training Per se?

Conditions
-----------------
Insulin Sensitivity

Intervention / Treatment
-----------------
* Behavioral: 12 weeks of lifestyle change


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight (body mass index 25-30 kg/m2) Weight stable (±2 kg during the past 6 months) Body fat% >25%, Maximal oxygen uptake <45 mL/min/kg Sedentary and healthy according to interview Fasting glucose <6.1 mmol/L Blood pressure <140/90 mmHg No first degree relatives with type-2-diabetes Exclusion Criteria: Resistance training Inability to meet intervention criteria

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physical training, unchanged diet<br>Daily endurance training equivalent to 600 kcal/day and unchanged habitual diet | Behavioral: 12 weeks of lifestyle change<br>* Participants were randomly assigned to a 12-week intervention in one of four groups: Training (T), energy-reduced Diet (D), Training and increased- Diet (T-iD) or Control (C). The interventions consisted of: T: increased physical activity through daily endurance training equivalent to 600 kcal/day, unchanged diet; D: sedentary lifestyle, reduced diet by 600 kcal/day primarily through reducing serving sizes and substituting energy dense with less energy dense nutrients; T-iD: increased physical activity through daily endurance training equivalent to 600 kcal/day, increased diet by 600 kcal/day primarily through increasing serving sizes and consuming energy dense nutrients; C: sedentary lifestyle and unchanged diet.<br>|
| Active Comparator: Physical training, increased diet<br>Daily endurance training equivalent to 600 kcal/day, and increased diet by 600 kcal/day. | Behavioral: 12 weeks of lifestyle change<br>* Participants were randomly assigned to a 12-week intervention in one of four groups: Training (T), energy-reduced Diet (D), Training and increased- Diet (T-iD) or Control (C). The interventions consisted of: T: increased physical activity through daily endurance training equivalent to 600 kcal/day, unchanged diet; D: sedentary lifestyle, reduced diet by 600 kcal/day primarily through reducing serving sizes and substituting energy dense with less energy dense nutrients; T-iD: increased physical activity through daily endurance training equivalent to 600 kcal/day, increased diet by 600 kcal/day primarily through increasing serving sizes and consuming energy dense nutrients; C: sedentary lifestyle and unchanged diet.<br>|
| Active Comparator: Diet, unchanged physical activity<br>Energy-reduced diet by 600 kcal/day, and unchanged sedentary lifestyle | Behavioral: 12 weeks of lifestyle change<br>* Participants were randomly assigned to a 12-week intervention in one of four groups: Training (T), energy-reduced Diet (D), Training and increased- Diet (T-iD) or Control (C). The interventions consisted of: T: increased physical activity through daily endurance training equivalent to 600 kcal/day, unchanged diet; D: sedentary lifestyle, reduced diet by 600 kcal/day primarily through reducing serving sizes and substituting energy dense with less energy dense nutrients; T-iD: increased physical activity through daily endurance training equivalent to 600 kcal/day, increased diet by 600 kcal/day primarily through increasing serving sizes and consuming energy dense nutrients; C: sedentary lifestyle and unchanged diet.<br>|
| No Intervention: Control<br>Unchanged sedentary lifestyle and diet | Behavioral: 12 weeks of lifestyle change<br>* Participants were randomly assigned to a 12-week intervention in one of four groups: Training (T), energy-reduced Diet (D), Training and increased- Diet (T-iD) or Control (C). The interventions consisted of: T: increased physical activity through daily endurance training equivalent to 600 kcal/day, unchanged diet; D: sedentary lifestyle, reduced diet by 600 kcal/day primarily through reducing serving sizes and substituting energy dense with less energy dense nutrients; T-iD: increased physical activity through daily endurance training equivalent to 600 kcal/day, increased diet by 600 kcal/day primarily through increasing serving sizes and consuming energy dense nutrients; C: sedentary lifestyle and unchanged diet.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin sensitivity | Before and after the 12 week interventions a 1-step, 120 min, hyperinsulinaemic, euglycemic clamp was performed. After an initial 2mL bolus of insulin infusate, insulin was infused at 40 microU/min/kg. | week 0 and 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body composition | Before, during and after the 12-week interventions changes in: Body mass, Lean body mass, Fat mass, Abdominal fat mass, and Viceral and subcutaneous fat were assesed by DEXA and MRI scans. | DEXA: week 0, 2, 6, 10, and 13; MRI: Week 0 and 13 |