Democritus University of Thrace, School of Physical Education and Sports Science
Komotini, 69100, Greece
NCT Number: NCT04098484
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.
Looking for future studies?
Notify Me35 year–50 year
Male
Interventional
Not applicable
Komotini, 69100, Greece
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will abstain from exercise throughout a 3-month period
Participants will execute a 3-month exercise training program
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
Time frame: At baseline as well as at 1,5 and 3 months in both trials
HDL concentration will be measured in blood
Time frame: At baseline as well as at 1,5 and 3 months in both trials
LDL concentration will be measured in blood
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Total cholesterol levels will measured in blood
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Triglycerides concentration will be measured in blood
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
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Glucose concentration will be measured in blood
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Glycosylated hemoglobin levels will be measured in blood
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Insulin concentration will be measured in blood
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
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
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
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Hemoglobin will be measured in blood samples
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Hematocrit levels will be measured in blood samples
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Transaminase levels will be measured in blood samples
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
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Total antioxidant capacity will be assessed in plasma
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
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Protein carbonyl formation will be measured in serum
Time frame: At baseline as well as at 1,5 and 3 months in both trials
TBARS will be measured in serum
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Catalase activity will be measured in serum
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
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
Time frame: At baseline as well as at 1,5 and 3 months in both trials
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
Democritus University of Thrace
Other
Biological Adaptations of Strength Training to Obese and Normal Weight Middle-aged Men
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.
Published trials that share one or more normalized conditions with this study.
NCT05268042
Body Weight, Digestive System Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT05804422
Body Weight, Digestive System Diseases
Kyiv, Ukraine
View Trial DetailsNCT05209100
Body Weight, Digestive System Diseases
Orlando, Florida, United States
View Trial DetailsNCT05724134
Body Weight, Diabetes Mellitus
New York, United States
View Trial Details