Biological Adaptations of Strength Training.
Primary Purpose
Non-Alcoholic Fatty Liver Disease
Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Control Trial
Exercise Trial
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Obesity, training, inflammation, Liver, oxidative stress
Eligibility 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
Sites / Locations
- Democritus University of Thrace, School of Physical Education and Sports ScienceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Normal-weight
Obese
Arm Description
Subjects with a BMI of 18-25 kg/m2
Subjects with a BMI of > 30 kg/m2
Outcomes
Primary Outcome Measures
Changes in body composition
Body composition will be assessed using Dual-energy-X-ray Absorptiometry (DXA) instrumentation
Changes in HDL concentration
HDL concentration will be measured in blood
Changes in LDL concentration
LDL concentration will be measured in blood
Changes in total cholesterol
Total cholesterol levels will measured in blood
Changes in triglycerides
Triglycerides concentration will be measured in blood
Changes in free fatty acids
Free fatty acid concentration will be measured in blood
Changes in glucose
Glucose concentration will be measured in blood
Changes in glycosylated hemoglobin
Glycosylated hemoglobin levels will be measured in blood
Changes in insulin
Insulin concentration will be measured in blood
Changes in insulin resistance index
Insulin resistance index will be calculated through glucose and insulin values
Changes in White Blood Cells
White blood cells will be measured in bood samples
Changes in Red Blood Cells
Red blood cells will be measured in bood samples
Changes in Hemoglobin
Hemoglobin will be measured in blood samples
Changes in Hematocrit
Hematocrit levels will be measured in blood samples
Changes in transaminases
Transaminase levels will be measured in blood samples
Changes in C-reactive protein
C-reactive protein levels will be measured in blood samples
Changes in total antioxidant capacity
Total antioxidant capacity will be assessed in plasma
Changes in glutathione
Oxidized (GSH) and reduced (GSSG) glutathione will be measured in red blood cell lysate
Changes in protein carbonyls
Protein carbonyl formation will be measured in serum
Changes in thiobarbituric acid reactive substances (TBARS)
TBARS will be measured in serum
Changes in catalase
Catalase activity will be measured in serum
Changes in fatty infiltration of the liver
Fatty infiltration of the liver will be assessed by ultrasound imaging of liver
Changes in bone status
Bone mineral density and bone mineral content will be assessed in hole body, spine and hips using DXA
Secondary Outcome Measures
Changes in body weight
Changes in muscle architecture
Muscle architecture of quadriceps will be assessed by ultrasonography
Full Information
NCT ID
NCT04098484
First Posted
September 19, 2019
Last Updated
April 1, 2023
Sponsor
Democritus University of Thrace
1. Study Identification
Unique Protocol Identification Number
NCT04098484
Brief Title
Biological Adaptations of Strength Training.
Official Title
Biological Adaptations of Strength Training to Obese and Normal Weight Middle-aged Men
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
December 25, 2020 (Actual)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Democritus University of Thrace
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
Keywords
Obesity, training, inflammation, Liver, oxidative stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal-weight
Arm Type
Active Comparator
Arm Description
Subjects with a BMI of 18-25 kg/m2
Arm Title
Obese
Arm Type
Experimental
Arm Description
Subjects with a BMI of > 30 kg/m2
Intervention Type
Other
Intervention Name(s)
Control Trial
Intervention Description
Participants will abstain from exercise throughout a 3-month period
Intervention Type
Other
Intervention Name(s)
Exercise Trial
Intervention Description
Participants will execute a 3-month exercise training program
Primary Outcome Measure Information:
Title
Changes in body composition
Description
Body composition will be assessed using Dual-energy-X-ray Absorptiometry (DXA) instrumentation
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in HDL concentration
Description
HDL concentration will be measured in blood
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in LDL concentration
Description
LDL concentration will be measured in blood
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in total cholesterol
Description
Total cholesterol levels will measured in blood
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in triglycerides
Description
Triglycerides concentration will be measured in blood
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in free fatty acids
Description
Free fatty acid concentration will be measured in blood
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in glucose
Description
Glucose concentration will be measured in blood
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in glycosylated hemoglobin
Description
Glycosylated hemoglobin levels will be measured in blood
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in insulin
Description
Insulin concentration will be measured in blood
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in insulin resistance index
Description
Insulin resistance index will be calculated through glucose and insulin values
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in White Blood Cells
Description
White blood cells will be measured in bood samples
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in Red Blood Cells
Description
Red blood cells will be measured in bood samples
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in Hemoglobin
Description
Hemoglobin will be measured in blood samples
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in Hematocrit
Description
Hematocrit levels will be measured in blood samples
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in transaminases
Description
Transaminase levels will be measured in blood samples
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in C-reactive protein
Description
C-reactive protein levels will be measured in blood samples
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in total antioxidant capacity
Description
Total antioxidant capacity will be assessed in plasma
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in glutathione
Description
Oxidized (GSH) and reduced (GSSG) glutathione will be measured in red blood cell lysate
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in protein carbonyls
Description
Protein carbonyl formation will be measured in serum
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in thiobarbituric acid reactive substances (TBARS)
Description
TBARS will be measured in serum
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in catalase
Description
Catalase activity will be measured in serum
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in fatty infiltration of the liver
Description
Fatty infiltration of the liver will be assessed by ultrasound imaging of liver
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in bone status
Description
Bone mineral density and bone mineral content will be assessed in hole body, spine and hips using DXA
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Secondary Outcome Measure Information:
Title
Changes in body weight
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
Title
Changes in muscle architecture
Description
Muscle architecture of quadriceps will be assessed by ultrasonography
Time Frame
At baseline as well as at 1,5 and 3 months in both trials
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Athanasios Chatzinikolaou, Associate Prof
Phone
0030 25310 39632
Email
achatzin@phyed.duth.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Antonis Kampas, Prof
Phone
0030 25310 39643
Email
akampas@phyed.duth.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Protopapa, PhDc
Organizational Affiliation
Democritus University of Thrace, School of Physical Education and Sports Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Democritus University of Thrace, School of Physical Education and Sports Science
City
Komotini
ZIP/Postal Code
69100
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athanasios Chatzinikolaou, Associate Prof
Phone
0030 2531039632
Email
achatzin@phyed.duth.gr
First Name & Middle Initial & Last Name & Degree
Antonis Kampas, Prof
Phone
0030 2531039643
Email
akampas@phyed.duth.gr
12. IPD Sharing Statement
Learn more about this trial
Biological Adaptations of Strength Training.
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