Biological Adaptations of Strength Training.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Interventions
- Other: Control TrialOther: Exercise Trial
- Registration Number
- NCT04098484
- Lead Sponsor
- Democritus University of Thrace
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal-weight Exercise Trial Subjects with a BMI of 18-25 kg/m2 Obese Control Trial Subjects with a BMI of \> 30 kg/m2 Normal-weight Control Trial Subjects with a BMI of 18-25 kg/m2 Obese Exercise Trial Subjects with a BMI of \> 30 kg/m2
- Primary Outcome Measures
Name Time Method Changes in total cholesterol At baseline as well as at 1,5 and 3 months in both trials Total cholesterol levels will measured in blood
Changes in HDL concentration At baseline as well as at 1,5 and 3 months in both trials HDL concentration will be measured in blood
Changes in glycosylated hemoglobin At baseline as well as at 1,5 and 3 months in both trials Glycosylated hemoglobin levels will be measured in blood
Changes in total antioxidant capacity At baseline as well as at 1,5 and 3 months in both trials Total antioxidant capacity will be assessed in plasma
Changes in body composition At baseline as well as at 1,5 and 3 months in both trials Body composition will be assessed using Dual-energy-X-ray Absorptiometry (DXA) instrumentation
Changes in glucose At baseline as well as at 1,5 and 3 months in both trials Glucose concentration will be measured in blood
Changes in insulin At baseline as well as at 1,5 and 3 months in both trials Insulin concentration will be measured in blood
Changes in insulin resistance index At baseline as well as at 1,5 and 3 months in both trials Insulin resistance index will be calculated through glucose and insulin values
Changes in Red Blood Cells At baseline as well as at 1,5 and 3 months in both trials Red blood cells will be measured in bood samples
Changes in transaminases At baseline as well as at 1,5 and 3 months in both trials Transaminase levels will be measured in blood samples
Changes in C-reactive protein At baseline as well as at 1,5 and 3 months in both trials C-reactive protein levels will be measured in blood samples
Changes in White Blood Cells At baseline as well as at 1,5 and 3 months in both trials White blood cells will be measured in bood samples
Changes in Hemoglobin At baseline as well as at 1,5 and 3 months in both trials Hemoglobin will be measured in blood samples
Changes in Hematocrit At baseline as well as at 1,5 and 3 months in both trials Hematocrit levels will be measured in blood samples
Changes in protein carbonyls At baseline as well as at 1,5 and 3 months in both trials Protein carbonyl formation will be measured in serum
Changes in thiobarbituric acid reactive substances (TBARS) At baseline as well as at 1,5 and 3 months in both trials TBARS will be measured in serum
Changes in catalase At baseline as well as at 1,5 and 3 months in both trials Catalase activity will be measured in serum
Changes in fatty infiltration of the liver At baseline as well as at 1,5 and 3 months in both trials Fatty infiltration of the liver will be assessed by ultrasound imaging of liver
Changes in LDL concentration At baseline as well as at 1,5 and 3 months in both trials LDL concentration will be measured in blood
Changes in triglycerides At baseline as well as at 1,5 and 3 months in both trials Triglycerides concentration will be measured in blood
Changes in free fatty acids At baseline as well as at 1,5 and 3 months in both trials Free fatty acid concentration will be measured in blood
Changes in glutathione At baseline as well as at 1,5 and 3 months in both trials Oxidized (GSH) and reduced (GSSG) glutathione will be measured in red blood cell lysate
Changes in bone status At baseline as well as at 1,5 and 3 months in both trials Bone mineral density and bone mineral content will be assessed in hole body, spine and hips using DXA
- Secondary Outcome Measures
Name Time Method Changes in body weight At baseline as well as at 1,5 and 3 months in both trials Changes in muscle architecture At baseline as well as at 1,5 and 3 months in both trials Muscle architecture of quadriceps will be assessed by ultrasonography
Trial Locations
- Locations (1)
Democritus University of Thrace, School of Physical Education and Sports Science
🇬🇷Komotini, Greece