Biological Adaptations of Strength Training.

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098484
• Other study ID #: EXERCISE-OBESITY-DUTH
• Status: Completed
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: October 2023
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 31, 2023
• Est. primary completion date: December 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Other:
• Control Trial
Participants will abstain from exercise throughout a 3-month period
• Exercise Trial
Participants will execute a 3-month exercise training program

Locations

Country	Name	City	State
Greece	Democritus University of Thrace, School of Physical Education and Sports Science	Komotini

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Changes in triglycerides	Triglycerides concentration will be measured in blood	At baseline as well as at 1,5 and 3 months in both trials
Primary	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
Primary	Changes in glucose	Glucose concentration will be measured in blood	At baseline as well as at 1,5 and 3 months in both trials
Primary	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
Primary	Changes in insulin	Insulin concentration will be measured in blood	At baseline as well as at 1,5 and 3 months in both trials
Primary	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
Primary	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
Primary	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
Primary	Changes in Hemoglobin	Hemoglobin will be measured in blood samples	At baseline as well as at 1,5 and 3 months in both trials
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Changes in catalase	Catalase activity will be measured in serum	At baseline as well as at 1,5 and 3 months in both trials
Primary	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
Primary	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	Changes in body weight		At baseline as well as at 1,5 and 3 months in both trials
Secondary	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