Biological Adaptations of Strength Training.

Sponsor
Democritus University of Thrace (Other)
Overall Status
Recruiting
CT.gov ID
NCT04098484
Collaborator
(none)
18
1
2
44.6
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Control Trial
  • Other: Exercise Trial
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Biological Adaptations of Strength Training to Obese and Normal Weight Middle-aged Men
Actual Study Start Date :
Apr 2, 2019
Actual Primary Completion Date :
Dec 25, 2020
Anticipated Study Completion Date :
Dec 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Changes in body composition [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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) [At baseline as well as at 1,5 and 3 months in both trials]

    TBARS will be measured in serum

  21. Changes in catalase [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 [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 [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 Outcome Measures

  1. Changes in body weight [At baseline as well as at 1,5 and 3 months in both trials]

  2. Changes in muscle architecture [At baseline as well as at 1,5 and 3 months in both trials]

    Muscle architecture of quadriceps will be assessed by ultrasonography

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Democritus University of Thrace, School of Physical Education and Sports Science Komotini Greece 69100

Sponsors and Collaborators

  • Democritus University of Thrace

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Athanasios Chatzinikolaou, Associate Professor, Democritus University of Thrace
ClinicalTrials.gov Identifier:
NCT04098484
Other Study ID Numbers:
  • EXERCISE-OBESITY-DUTH
First Posted:
Sep 23, 2019
Last Update Posted:
Mar 23, 2022
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Athanasios Chatzinikolaou, Associate Professor, Democritus University of Thrace
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2022