NAFLDNCT06257732
Different Exercise Modalities in the Treatment of NAFLD and Their Impact on Myokines
A study testing Exercise and Motivational Interviewing in people with NAFLD and Nonalcoholic Fatty Liver Disease, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this 12-week clinical trial is to investigate the effectiveness of different exercise types in treating Non-Alcoholic Fatty Liver Disease (NAFLD) and to explore their impact on myokine levels associated with lipid metabolism. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- NAFLD, Nonalcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic
- What is being tested?
- Exercise and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2024to 15 Oct 2024
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have received a diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD)
- Age between 25 and 50 years old
- Use of smartphone
- Fall into category A or B according to the American Heart Association Risk Assessment Criteria
Who cannot join
- Viral hepatitis
- Excessive alcohol consumption (more than 30 grams per day for men and more than 20 grams per day for women)
- Use of specific medications: amiodarone, corticosteroids, methotrexate, tamoxifen, synthetic estrogen, valproic acid, intravenous tetracycline, and highly active antiretroviral drugs
- Presence of accompanying chronic diseases such as Wilson's disease, hemochromatosis, and celiac disease
- Liver storage diseases
- Cancer
Show all 17Show fewer
- Cirrhosis
- Advanced changes in liver ultrasonography evaluations, such as fibrosis
- Presence of other chronic diseases (kidney failure, heart failure, atherosclerotic heart disease, hypertension, arrhythmia disorders)
- BMI greater than 40 kg/m²
- History of surgery or trauma in the last 6 months
- Orthopedic and/or neurological impairment
- Health problems that may hinder participation in the exercise program
- Regular and continuous participation in sports or exercise at least 3 times a week for the past 3 years
- Family history of coronary artery disease (coronary artery disease before the age of 45 in male first-degree relatives and other male relatives, or before the age of 65 in female first-degree relatives and other female relatives)
- Presence of specific symptoms during medical history or physical examination: chest pain radiating to the neck, jaw, or arm, shortness of breath during rest or physical activity, dizziness, fainting, orthopnea or paroxysmal nocturnal dyspnea, ankle edema, palpitations or tachycardia, intermittent claudication, heart murmur, unexplained excessive fatigue
- Fall into category C or D according to the American Heart Association Risk Assessment Criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yeditepe University
Istanbul, Ataşehir, 34755
Meltem Yalçın Oğuz, MSc, Pt, +90 (216) 578 00 00 ext. 1533, meltem.yalcin@yeditepe.edu.tr
Burçin Tuvana Us, MD, +90 (216) 578 00 00 ext. 1533, tuvana.us@yeditepe.edu.tr
About this study
Official title: Investigation of Effectiveness of Different Exercise Types, and Their Therapeutic Effect Mechanisms and the Roles of Motivational Interview in the Treatment of Non-Alcoholic Fatty Liver Disease
The goal of this 12-week clinical trial is to investigate the effectiveness of different exercise types in treating Non-Alcoholic Fatty Liver Disease (NAFLD) and to explore their impact on myokine levels associated with lipid metabolism. The main questions it aims to answer are:
- How does the type and dose of exercise affect the treatment of NAFLD?
- What is the influence of exercise interventions in NAFLD treatment on myokine levels related to lipid metabolism?
- How does motivational interviewing contribute to lifestyle modification in the treatment of NAFLD?
Participants in this study will engage in assigned exercise routines randomly, including HIIT, resistance training, or FATmax exercises. Additionally, motivational interviewing techniques will be employed to assess their impact on lifestyle changes. Researchers will compare the outcomes among the different exercise groups, along with a control group receiving only standard care for NAFLD. This comparison aims to determine the respective effects of these interventions on both NAFLD and associated myokine levels.
- Being tested
- Exercise, Motivational Interviewing
- Keywords
- Exercise, Myokine, HIIT, Fatmax Intensity, Resistance Exercise, Motivational Interviewing, NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The exercise interventions in this study include High-Intensity Interval Training (HIIT), involving brief bursts of intense exercise; Resistance Exercise, focusing on strength and muscle endurance; and Fatmax Exercise, tailored to optimize fat oxidation during aerobic activity.
Motivational InterviewingBehavioural
Motivational Interviewing will be employed as a counseling technique to elicit behavior change by fostering collaborative and empathetic conversations, enhancing motivation for positive lifestyle modifications in individuals with liver fat accumulation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This group will consist of individuals with liver fat accumulation under standard care and no exercise intervention will be implemented. |
| Fatmax Exercise Group | Experimental | Individuals with liver fat accumulation under standard care will have their Fatmax values calculated and an exercise prescription will be designed accordingly. Receives: Other: Exercise |
| Fatmax Exercise and Motivational Interviewing Group | Experimental | In addition to the prescription of Fatmax exercise for individuals with liver fat accumulation under standard care, motivational interviewing principles will be applied. Receives: Other: Exercise; Behavioral: Motivational Interviewing |
| HIIT Group | Experimental | Individuals with liver fat accumulation under standard care will be provided with a High-Intensity Interval Training (HIIT) exercise prescription. Receives: Other: Exercise |
| HIIT and Motivational Interviewing Group | Experimental | In addition to formulating a High-Intensity Interval Training (HIIT) exercise prescription for individuals with liver fat accumulation under standard care, motivational interviewing principles will be applied. Receives: Other: Exercise; Behavioral: Motivational Interviewing |
| Resistance Exercise Group | Experimental | Individuals with liver fat accumulation under standard care will be provided with a resistance exercise prescription. Receives: Other: Exercise |
| Resistance Exercise and Motivational Interviewing Group | Experimental | In addition to formulating a resistance exercise prescription for individuals under standard care with liver fat accumulation, motivational interviewing principles will be applied. Receives: Other: Exercise; Behavioral: Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the liver steatosis grade
Changes in the level of liver fat accumulation in radiological abdominal ultrasonography (USG) will be observed. The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Secondary outcomes (28)
ALT
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
AST
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
GGT
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Free fatty acids
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Triglycerides
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
HDL
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
LDL
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Total cholesterol
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
CRP
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
ESR
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in body weight
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in lean body mass
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in body fat percentage
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in body mass index
The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in waist-to-hip ratio
The waist and hip measurements will be taken twice with a tape measure. The results will be aggregated to arrive at one reported value as a waist-to-hip ratio. This is calculated as waist measurement divided by hip measurement (W⁄H). The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in peak oxygen consumption
At the beginning, every 4 weeks, and at the end of the study, peak oxygen consumption measurement will be conducted through the cardiopulmonary exercise test. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in peak heart rate
At the beginning, every 4 weeks, and at the end of the study, peak heart rate measurement will be conducted through the cardiopulmonary exercise test. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in anaerobic threshold
At the beginning, every 4 weeks, and at the end of the study, anaerobic threshold measurements will be conducted through the cardiopulmonary exercise test. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in basal metabolic rate
Basal metabolic rate measurements will be conducted twice using an indirect calorimeter, once at the beginning and once at the end of the study. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in muscle strength analysis results
At the beginning and end of the study, the maximum isometric contraction strength of the hand and forearm muscles will be measured using a hand dynamometer. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in The 5 Times Sit-to-Stand Test results
The 5 Times Sit-to-Stand Test will be administered as a balance test. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in Single Leg Standing Test results
The Single Leg Standing Test will be administered as a balance test. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in FATmax levels
At the beginning and end of the study, participants' FATmax levels will be determined through the FATmax test. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in Healthy Lifestyle Habits Scale II scores
At the beginning and end of the study, a total of two administrations of the questionnaires will be conducted. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in Short Form Survey (SF-36) scores
At the beginning and end of the study, a total of two administrations of the questionnaires will be conducted. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in Beck Depression Scale scores
At the beginning and end of the study, a total of two administrations of the questionnaires will be conducted. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in Pittsburgh Sleep Quality Index scores
At the beginning and end of the study, a total of two administrations of the questionnaires will be conducted. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Changes in the serum levels of myokines
Serum samples will be obtained twice, at the beginning and end of the study. Musclin, myonectin, and myostatin levels will be measured using ELISA, while measurements of BAIBA will be conducted using Liquid Chromatography Spectrometry. Data collected at the beginning and end of the study will be compared.
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start5 Jan 2024
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257732
- Sponsor's protocol ID
- TBTK-MK-2022
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effectiveness of Different Exercise Types, and Their Therapeutic Effect Mechanisms and the Roles of Motivational Interview in the Treatment of Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06257732
- Acronym / sponsor ID
- TBTK-MK-2022
- Keywords
- Exercise, Myokine, HIIT, Fatmax Intensity, Resistance Exercise, Motivational Interviewing, NAFLD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 14 Feb 2024 (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.
The goal of this 12-week clinical trial is to investigate the effectiveness of different exercise types in treating Non-Alcoholic Fatty Liver Disease (NAFLD) and to explore their impact on myokine levels associated with lipid metabolism. The main questions it aims to answer are:
- How does the type and dose of exercise affect the treatment of NAFLD?
- What is the influence of exercise interventions in NAFLD treatment on myokine levels related to lipid metabolism?
- How does motivational interviewing contribute to lifestyle modification in the treatment of NAFLD?
Participants in this study will engage in assigned exercise routines randomly, including HIIT, resistance training, or FATmax exercises. Additionally, motivational interviewing techniques will be employed to assess their impact on lifestyle changes. Researchers will compare the outcomes among the different exercise groups, along with a control group receiving only standard care for NAFLD. This comparison aims to determine the respective effects of these interventions on both NAFLD and associated myokine levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will consist of individuals with liver fat accumulation under standard care and no exercise intervention will be implemented. |
| Fatmax Exercise Group | Experimental | Other: ExerciseIndividuals with liver fat accumulation under standard care will have their Fatmax values calculated and an exercise prescription will be designed accordingly. |
| Fatmax Exercise and Motivational Interviewing Group | Experimental | Other: Exercise, Behavioral: Motivational InterviewingIn addition to the prescription of Fatmax exercise for individuals with liver fat accumulation under standard care, motivational interviewing principles will be applied. |
| HIIT Group | Experimental | Other: ExerciseIndividuals with liver fat accumulation under standard care will be provided with a High-Intensity Interval Training (HIIT) exercise prescription. |
| HIIT and Motivational Interviewing Group | Experimental | Other: Exercise, Behavioral: Motivational InterviewingIn addition to formulating a High-Intensity Interval Training (HIIT) exercise prescription for individuals with liver fat accumulation under standard care, motivational interviewing principles will be applied. |
| Resistance Exercise Group | Experimental | Other: ExerciseIndividuals with liver fat accumulation under standard care will be provided with a resistance exercise prescription. |
| Resistance Exercise and Motivational Interviewing Group | Experimental | Other: Exercise, Behavioral: Motivational InterviewingIn addition to formulating a resistance exercise prescription for individuals under standard care with liver fat accumulation, motivational interviewing principles will be applied. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Have received a diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD)
- Age between 25 and 50 years old
- Use of smartphone
- Fall into category A or B according to the American Heart Association Risk Assessment Criteria
Key exclusion criteria (17 listed)
- Viral hepatitis
- Excessive alcohol consumption (more than 30 grams per day for men and more than 20 grams per day for women)
- Use of specific medications: amiodarone, corticosteroids, methotrexate, tamoxifen, synthetic estrogen, valproic acid, intravenous tetracycline, and highly active antiretroviral drugs
- Presence of accompanying chronic diseases such as Wilson's disease, hemochromatosis, and celiac disease
- Liver storage diseases
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 |
|---|---|---|
| ExerciseThe exercise interventions in this study include High-Intensity Interval Training (HIIT), involving brief bursts of intense exercise; Resistance Exercise, focusing on strength and muscle endurance; and Fatmax Exercise, tailored to optimize fat oxidation during aerobic activity. | Other | Fatmax Exercise Group, Fatmax Exercise and Motivational Interviewing Group, HIIT Group, HIIT and Motivational Interviewing Group, Resistance Exercise Group, Resistance Exercise and Motivational Interviewing Group |
| Motivational InterviewingMotivational Interviewing will be employed as a counseling technique to elicit behavior change by fostering collaborative and empathetic conversations, enhancing motivation for positive lifestyle modifications in individuals with liver fat accumulation. | Behavioural | Fatmax Exercise and Motivational Interviewing Group, HIIT and Motivational Interviewing Group, Resistance Exercise and Motivational Interviewing Group |
Primary outcome
Change in the liver steatosis grade
Time frame: 12-week
Changes in the level of liver fat accumulation in radiological abdominal ultrasonography (USG) will be observed. The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
28 secondary outcomes
ALT
Time frame: 12-week
AST
Time frame: 12-week
GGT
Time frame: 12-week
Free fatty acids
Time frame: 12-week
Triglycerides
Time frame: 12-week
HDL
Time frame: 12-week
LDL
Time frame: 12-week
Total cholesterol
Time frame: 12-week
CRP
Time frame: 12-week
ESR
Time frame: 12-week
Changes in body weight
Time frame: 12-week
Changes in lean body mass
Time frame: 12-week
Changes in body fat percentage
Time frame: 12-week
Changes in body mass index
Time frame: 12-week
Changes in waist-to-hip ratio
Time frame: 12-week
Changes in peak oxygen consumption
Time frame: 12-week
Changes in peak heart rate
Time frame: 12-week
Changes in anaerobic threshold
Time frame: 12-week
Changes in basal metabolic rate
Time frame: 12-week
Changes in muscle strength analysis results
Time frame: 12-week
Changes in The 5 Times Sit-to-Stand Test results
Time frame: 12-week
Changes in Single Leg Standing Test results
Time frame: 12-week
Changes in FATmax levels
Time frame: 12-week
Changes in Healthy Lifestyle Habits Scale II scores
Time frame: 12-week
Changes in Short Form Survey (SF-36) scores
Time frame: 12-week
Changes in Beck Depression Scale scores
Time frame: 12-week
Changes in Pittsburgh Sleep Quality Index scores
Time frame: 12-week
Changes in the serum levels of myokines
Time frame: 12-week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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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.
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 and Motivational Interviewing in people with NAFLD and Nonalcoholic Fatty Liver Disease, run by Yeditepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehtap Kaçar, MD, PhD, Prof (+90 (216) 578 00 00 ext. 1419, mehtap.kacar@yeditepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the liver steatosis grade (time frame: 12-week). 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 26 Feb 2024.