Biological Adaptations of Strength Training.

Study Overview
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Brief Summary
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A two-trial repeated measures design will be employed in this investigation. Both the control trial and the exercise trial will last for 3 months. During a week before the start of the study, participants will complete dietary recalls and record their habitual physical activity using accelerometers. Thereafter, body composition, ultrasound imaging of the muscle and liver, biochemical and hematological markers were measured. This range of measurements will be repeated the ended each month for both trials. Control trial succeeds exercise trial. An exercise intervention program will take place in the second trial, three times a week.

Detailed Description
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A sample size of 30 volunteers, aged 35-45 years, will participate in the present study. Of them, 15 will be normal weight and 15 will suffer from fatty liver disease (BMI 29-35 kg/m2, waist size >102 cm). The exclusion criteria will be a) medication, b) musculoskeletal problems that will prevent participation in the training program, c) known condition or medical condition preventing participation in the program e.g. hypertension, d) BMI> 35kg / m2, (e) a severe family medical history up to first degree relatives with cardiovascular disease and / or diabetes at the age of less than 65 for women and less than 55 years for men and (f) smoking. After informing and receiving a questionnaire and medical history, volunteers will sign for their participation in the survey. A two-trial repeated measures design will be applied in this investigation. Both control and exercise trials will last for 3 months. During the week preceding the commencement of the study, participants will complete dietary recalls and will have their habitual physical activity monitored, by utilizing accelerometers. Thereafter, body composition, ultrasound imaging of muscle and liver, biochemical and hematological markers will be measured. The same measurements will be repeated at the end of each month, in both trials. Control trial will be executed prior to exercise trial. An exercise intervention program, combining strength and cardiovascular exercises performed three times a week, will take place in the exercise trial.

Official Title
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Biological Adaptations of Strength Training to Obese and Normal Weight Middle-aged Men

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Other: Control Trial
* Other: Exercise Trial


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no use of medication free of musculoskeletal limitations absence of a known condition or medical condition preventing participation in the program (e.g. hypertension) absence of a severe family medical history up to first degree relatives with cardiovascular disease and /or diabetes at the age of less than 65 for women and less than 55 years for men non-smokers Exclusion Criteria: use of medication musculoskeletal limitations that will prevent participation in the training program known condition or medical condition preventing participation in the program (e.g. hypertension) a severe family medical history up to first degree relatives with cardiovascular disease and /or diabetes at the age of less than 65 for women and less than 55 years for men smoking

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal-weight<br>Subjects with a BMI of 18-25 kg/m2 | Other: Control Trial<br>* Participants will abstain from exercise throughout a 3-month period<br>Other: Exercise Trial<br>* Participants will execute a 3-month exercise training program<br>|
| Experimental: Obese<br>Subjects with a BMI of > 30 kg/m2 | Other: Control Trial<br>* Participants will abstain from exercise throughout a 3-month period<br>Other: Exercise Trial<br>* Participants will execute a 3-month exercise training program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body composition | Body composition will be assessed using Dual-energy-X-ray Absorptiometry (DXA) instrumentation | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in HDL concentration | HDL concentration will be measured in blood | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in LDL concentration | LDL concentration will be measured in blood | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in total cholesterol | Total cholesterol levels will measured in blood | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in triglycerides | Triglycerides concentration will be measured in blood | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in free fatty acids | Free fatty acid concentration will be measured in blood | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in glucose | Glucose concentration will be measured in blood | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in glycosylated hemoglobin | Glycosylated hemoglobin levels will be measured in blood | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in insulin | Insulin concentration will be measured in blood | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in insulin resistance index | Insulin resistance index will be calculated through glucose and insulin values | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in White Blood Cells | White blood cells will be measured in bood samples | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in Red Blood Cells | Red blood cells will be measured in bood samples | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in Hemoglobin | Hemoglobin will be measured in blood samples | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in Hematocrit | Hematocrit levels will be measured in blood samples | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in transaminases | Transaminase levels will be measured in blood samples | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in C-reactive protein | C-reactive protein levels will be measured in blood samples | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in total antioxidant capacity | Total antioxidant capacity will be assessed in plasma | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in glutathione | Oxidized (GSH) and reduced (GSSG) glutathione will be measured in red blood cell lysate | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in protein carbonyls | Protein carbonyl formation will be measured in serum | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in thiobarbituric acid reactive substances (TBARS) | TBARS will be measured in serum | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in catalase | Catalase activity will be measured in serum | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in fatty infiltration of the liver | Fatty infiltration of the liver will be assessed by ultrasound imaging of liver | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in bone status | Bone mineral density and bone mineral content will be assessed in hole body, spine and hips using DXA | At baseline as well as at 1,5 and 3 months in both trials | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight |  | At baseline as well as at 1,5 and 3 months in both trials | 
| Changes in muscle architecture | Muscle architecture of quadriceps will be assessed by ultrasonography | At baseline as well as at 1,5 and 3 months in both trials | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, training, inflammation, Liver, oxidative stress