Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
Obesity, training, inflammation, Liver, oxidative stress
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.
Interventions
OTHERControl Trial
Participants will abstain from exercise throughout a 3-month period
OTHERExercise Trial
Participants will execute a 3-month exercise training program
Sponsors
Democritus University of Thrace
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 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 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 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 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 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 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 glucose | At baseline as well as at 1,5 and 3 months in both trials | Glucose 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 insulin | At baseline as well as at 1,5 and 3 months in both trials | Insulin concentration will be measured in blood |
| 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 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 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 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 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Changes in body weight | At baseline as well as at 1,5 and 3 months in both trials | — |
Countries
Greece
Outcome results
None listed