Physical Training Per se

NCT ID: NCT01090869

Last Updated: 2010-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-06-30

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

Conditions

Insulin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Physical training, unchanged diet

Daily endurance training equivalent to 600 kcal/day and unchanged habitual diet

Group Type: ACTIVE_COMPARATOR

12 weeks of lifestyle change

Intervention Type: BEHAVIORAL

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.

Physical training, increased diet

Daily endurance training equivalent to 600 kcal/day, and increased diet by 600 kcal/day.

Group Type: ACTIVE_COMPARATOR

12 weeks of lifestyle change

Intervention Type: BEHAVIORAL

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.

Diet, unchanged physical activity

Energy-reduced diet by 600 kcal/day, and unchanged sedentary lifestyle

Group Type: ACTIVE_COMPARATOR

12 weeks of lifestyle change

Intervention Type: BEHAVIORAL

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.

Control

Unchanged sedentary lifestyle and diet

Group Type: NO_INTERVENTION

12 weeks of lifestyle change

Intervention Type: BEHAVIORAL

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.

Interventions

12 weeks of lifestyle change

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

University of Copenhagen

Principal Investigators

Pernille Nordby, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

University of Copenhagen, Faculty Of Health Sciences, Department of Biomedical Sciences

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-KF-2006-6443

Identifier Type: -

Identifier Source: org_study_id