Clinical trial NCT04098484: Biological Adaptations of Strength Training.
Official title: Biological Adaptations of Strength Training to Obese and Normal Weight Middle-aged Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Obesity, training, inflammation, Liver, oxidative stress
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 20
Sex: MALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in body composition
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in HDL concentration
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in LDL concentration
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in total cholesterol
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in triglycerides
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in free fatty acids
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in glucose
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in glycosylated hemoglobin
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in insulin
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in insulin resistance index
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in White Blood Cells
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in Red Blood Cells
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in Hemoglobin
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in Hematocrit
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in transaminases
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in C-reactive protein
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in total antioxidant capacity
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in glutathione
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in protein carbonyls
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in thiobarbituric acid reactive substances (TBARS)
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in catalase
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in fatty infiltration of the liver
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in bone status
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
Secondary outcomes:
measure: Changes in body weight
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
measure: Changes in muscle architecture
timeFrame: At baseline as well as at 1,5 and 3 months in both trials
Other outcomes:
Locations:
city: Komotini
country: Greece
facility: Democritus University of Thrace, School of Physical Education and Sports Science
Study officials:
affiliation: Democritus University of Thrace, School of Physical Education and Sports Science
name: Maria Protopapa, PhDc
role: PRINCIPAL_INVESTIGATOR
References: