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Completed

NCT Number: NCT04098484

Biological Adaptations of Strength Training.

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.

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Key information

Age range

35 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Komotini, 69100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Trial

Other

Participants will abstain from exercise throughout a 3-month period

Exercise trial

Other

Participants will execute a 3-month exercise training program

Primary outcomes

  1. Changes in body composition

    Time frame: 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

  2. Changes in HDL concentration

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    HDL concentration will be measured in blood

  3. Changes in LDL concentration

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    LDL concentration will be measured in blood

  4. Changes in total cholesterol

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Total cholesterol levels will measured in blood

  5. Changes in triglycerides

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Triglycerides concentration will be measured in blood

  6. Changes in free fatty acids

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Free fatty acid concentration will be measured in blood

  7. Changes in glucose

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Glucose concentration will be measured in blood

  8. Changes in glycosylated hemoglobin

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Glycosylated hemoglobin levels will be measured in blood

  9. Changes in insulin

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Insulin concentration will be measured in blood

  10. Changes in insulin resistance index

    Time frame: 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

  11. Changes in White Blood Cells

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    White blood cells will be measured in bood samples

  12. Changes in Red Blood Cells

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Red blood cells will be measured in bood samples

  13. Changes in Hemoglobin

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Hemoglobin will be measured in blood samples

  14. Changes in Hematocrit

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Hematocrit levels will be measured in blood samples

  15. Changes in transaminases

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Transaminase levels will be measured in blood samples

  16. Changes in C-reactive protein

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    C-reactive protein levels will be measured in blood samples

  17. Changes in total antioxidant capacity

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Total antioxidant capacity will be assessed in plasma

  18. Changes in glutathione

    Time frame: 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

  19. Changes in protein carbonyls

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Protein carbonyl formation will be measured in serum

  20. Changes in thiobarbituric acid reactive substances (TBARS)

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    TBARS will be measured in serum

  21. Changes in catalase

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Catalase activity will be measured in serum

  22. Changes in fatty infiltration of the liver

    Time frame: 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

  23. Changes in bone status

    Time frame: 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

Secondary outcomes

  1. Changes in body weight

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

  2. Changes in muscle architecture

    Time frame: At baseline as well as at 1,5 and 3 months in both trials

    Muscle architecture of quadriceps will be assessed by ultrasonography

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Sep 23, 2019
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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