Biological Adaptations of Strength Training.

NCT04098484 | Completed

• 1 other identifier: EXERCISE-OBESITY-DUTH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Obesity, training, inflammation, Liver, oxidative stress

Outcome Measures

Primary Outcomes (23)

• 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 Outcomes (2)

• 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

Study Arms (2)

Normal-weight

ACTIVE COMPARATOR

Subjects with a BMI of 18-25 kg/m2

Other: Control Trial; Other: Exercise Trial

Obese

EXPERIMENTAL

Subjects with a BMI of \> 30 kg/m2

Other: Control Trial; Other: Exercise Trial

Interventions

Control Trial OTHER

Participants will abstain from exercise throughout a 3-month period

Normal-weight; Obese

Exercise Trial OTHER

Participants will execute a 3-month exercise training program

Normal-weight; Obese

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Democritus University of Thrace, School of Physical Education and Sports Science

Komotini, 69100, Greece

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Inflammation

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Maria Protopapa, PhDc

  Democritus University of Thrace, School of Physical Education and Sports Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: April 2, 2019
• Primary Completion: December 25, 2020
• Study Completion: October 31, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

GR (1)