Biological Adaptations of Strength Training.

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Control Trial; Other: Exercise Trial

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Komotini, Greece, 69100
    • Democritus University of Thrace, School of Physical Education and Sports Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Democritus University of Thrace
• Investigators: Principal Investigator: Maria Protopapa, PhDc, Democritus University of Thrace, School of Physical Education and Sports Science

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): December 25, 2020
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Obesity, training, inflammation, Liver, oxidative stress
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: EXERCISE-OBESITY-DUTH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No