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Biological Adaptations of Strength Training.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098484
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Athanasios Chatzinikolaou, Democritus University of Thrace

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
Fatty Liver Disease Other: Control Trial Other: Exercise Trial Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 : April 2, 2019
Estimated Primary Completion Date : December 25, 2019
Estimated Study Completion Date : June 20, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 meaasured in blood

  9. Changes in insulin [ Time Frame: At baseline as well as at 1,5 and 3 months in both trials ]
    Isulin 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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098484


Contacts
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Contact: Athanasios Chatzinikolaou, Associate Prof 0030 25310 39632 achatzin@phyed.duth.gr
Contact: Antonis Kampas, Prof 0030 25310 39643 akampas@phyed.duth.gr

Locations
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Greece
Democritus University of Thrace, School of Physical Education and Sports Science Recruiting
Komotini, Greece, 69100
Contact: Athanasios Chatzinikolaou, Associate Prof    0030 2531039632    achatzin@phyed.duth.gr   
Contact: Antonis Kampas, Prof    0030 2531039643    akampas@phyed.duth.gr   
Sponsors and Collaborators
Democritus University of Thrace
Investigators
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Principal Investigator: Maria Protopapa, PhDc Democritus University of Thrace, School of Physical Education and Sports Science

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Responsible Party: Athanasios Chatzinikolaou, Associate Professor, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT04098484    
Other Study ID Numbers: EXERCISE-OBESITY-DUTH
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Athanasios Chatzinikolaou, Democritus University of Thrace:
Obesity, strength training, cardiovascular training, inflammation, Liver, oxidative stress
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Digestive System Diseases