Non-Alcoholic Fatty Liver DiseaseNCT04098484
Biological Adaptations of Strength Training.
A study testing Exercise Trial in people with Non-Alcoholic Fatty Liver Disease, run by Democritus University of Thrace at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 35 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Exercise Trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 2 Apr 2019to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Democritus University of Thrace, School of Physical Education and Sports Science
Komotini, 69100
About this study
Official title: Biological Adaptations of Strength Training to Obese and Normal Weight Middle-aged Men
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Control Trial, Exercise Trial
- Keywords
- Obesity, training, inflammation, Liver, oxidative stress
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control TrialOther
Participants will abstain from exercise throughout a 3-month period
Exercise TrialOther
Participants will execute a 3-month exercise training program
| Study group | Role | What they receive |
|---|---|---|
| Normal-weight | Active comparator | Subjects with a BMI of 18-25 kg/m2 Receives: Other: Control Trial; Other: Exercise Trial |
| Obese | Experimental | Subjects with a BMI of > 30 kg/m2 Receives: Other: Control Trial; Other: Exercise Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body composition
Body composition will be assessed using Dual-energy-X-ray Absorptiometry (DXA) instrumentation
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in HDL concentration
HDL concentration will be measured in blood
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in LDL concentration
LDL concentration will be measured in blood
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in total cholesterol
Total cholesterol levels will measured in blood
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in triglycerides
Triglycerides concentration will be measured in blood
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in free fatty acids
Free fatty acid concentration will be measured in blood
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in glucose
Glucose concentration will be measured in blood
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in glycosylated hemoglobin
Glycosylated hemoglobin levels will be measured in blood
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in insulin
Insulin concentration will be measured in blood
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in insulin resistance index
Insulin resistance index will be calculated through glucose and insulin values
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in White Blood Cells
White blood cells will be measured in bood samples
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in Red Blood Cells
Red blood cells will be measured in bood samples
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in Hemoglobin
Hemoglobin will be measured in blood samples
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in Hematocrit
Hematocrit levels will be measured in blood samples
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in transaminases
Transaminase levels will be measured in blood samples
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in C-reactive protein
C-reactive protein levels will be measured in blood samples
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in total antioxidant capacity
Total antioxidant capacity will be assessed in plasma
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in glutathione
Oxidized (GSH) and reduced (GSSG) glutathione will be measured in red blood cell lysate
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in protein carbonyls
Protein carbonyl formation will be measured in serum
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in thiobarbituric acid reactive substances (TBARS)
TBARS will be measured in serum
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in catalase
Catalase activity will be measured in serum
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in fatty infiltration of the liver
Fatty infiltration of the liver will be assessed by ultrasound imaging of liver
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in bone status
Bone mineral density and bone mineral content will be assessed in hole body, spine and hips using DXA
Measured: At baseline as well as at 1,5 and 3 months in both trials
Secondary outcomes (2)
Changes in body weight
Measured: At baseline as well as at 1,5 and 3 months in both trials
Changes in muscle architecture
Muscle architecture of quadriceps will be assessed by ultrasonography
Measured: At baseline as well as at 1,5 and 3 months in both trials
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start2 Apr 2019
- Primary completion25 Dec 2020
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanasios Chatzinikolaou, Democritus University of Thrace
- Investigators
- Maria Protopapa, PhDc, Principal investigator, Democritus University of Thrace, School of Physical Education and Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098484
- Sponsor's protocol ID
- EXERCISE-OBESITY-DUTH
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2019
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Adaptations of Strength Training to Obese and Normal Weight Middle-aged Men
- ClinicalTrials.gov ID
- NCT04098484
- Acronym / sponsor ID
- EXERCISE-OBESITY-DUTH
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Obesity, training, inflammation, Liver, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal-weight | Active comparator | Other: Control Trial, Other: Exercise TrialSubjects with a BMI of 18-25 kg/m2 |
| Obese | Experimental | Other: Control Trial, Other: Exercise TrialSubjects with a BMI of > 30 kg/m2 |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control TrialParticipants will abstain from exercise throughout a 3-month period | Other | Normal-weight, Obese |
| Exercise TrialParticipants will execute a 3-month exercise training program | Other | Normal-weight, Obese |
Primary outcome
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
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
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
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
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
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
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
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 measured in blood
Changes in insulin
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Insulin concentration will be measured in blood
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
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
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
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
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
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
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
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
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
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
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
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
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
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
2 secondary outcomes
Changes in body weight
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Changes in muscle architecture
Time frame: At baseline as well as at 1,5 and 3 months in both trials
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
Related trials for Non-Alcoholic Fatty Liver Disease
Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Active, not recruitingPhase 2
Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH)
NASH
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Protopapa, PhDc principal investigator
Democritus University of Thrace, School of Physical Education and Sports Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Trial in people with Non-Alcoholic Fatty Liver Disease, run by Democritus University of Thrace at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body composition (time frame: At baseline as well as at 1,5 and 3 months in both trials). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.