Other Clinical Trial - Biological Adaptations of Strength Training.

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Fatty Liver
Liver Diseases
Non-Alcoholic Fatty Liver Disease

Clinical Trial Details

NCT number	NCT04098484
Study type	Interventional
Source	Democritus University of Thrace
Contact
Status	Completed
Phase	N/A
Start date	April 2, 2019
Completion date	October 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05480696` - Soluble Fibre Supplementation in NAFLD	Phase 1
Active, not recruiting	`NCT02500147` - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)	Phase 4
Completed	`NCT04671186` - Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan	N/A
Recruiting	`NCT05979779` - Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis	Phase 2
Recruiting	`NCT05462353` - Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH	Phase 2
Completed	`NCT05006885` - ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)	Phase 1
Completed	`NCT04117802` - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome	N/A
Recruiting	`NCT04365855` - The Olmsted NAFLD Epidemiology Study (TONES)	N/A
Recruiting	`NCT05618626` - Prevention of NAFLD and CVD Through Lifestyle Intervention	N/A
Completed	`NCT03256526` - 6-week Safety and PD Study in Adults With NAFLD	Phase 2
Enrolling by invitation	`NCT06152991` - Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy	Phase 3
Completed	`NCT03681457` - Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects	Phase 1
Completed	`NCT06244550` - Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors	N/A
Not yet recruiting	`NCT05120557` - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH	N/A
Completed	`NCT03060694` - Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
Completed	`NCT02526732` - Hepatic Inflammation and Physical Performance in Patients With NASH	N/A
Recruiting	`NCT01988441` - The Influence of Autophagy on Fatty Liver
Recruiting	`NCT01680003` - Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease	Phase 2
Completed	`NCT01712711` - Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease	Phase 2
Recruiting	`NCT00941642` - Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.