NAFLDNCT06220695
A Nutrigenetic Intervention in MASLD
A study testing Dietary intervention in people with NAFLD and Fatty Liver, run by Maastricht University at 1 site in Turkey (Türkiye).
Trial summary
The study is designed as a 12-week randomized controlled dietary intervention in individuals who had been diagnosed with NAFLD in the last 6 months and whose body mass index is above 25 at the time of participation in the pre-screening. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Fatty Liver
- What is being tested?
- Dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2023to 18 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand and sign informed consent
- BMI> 25 kg/m2
- Between 18-80 years
- previous clinical diagnosis of MASLD by abdominal USG, MRI, FibroScan® or liver biopsy
Who cannot join
- Excessive alcohol use (more than 20 g/day for women and 30g/day for men= >2 units alcohol/day for women and >3 units for men)
- Other liver diseases: Hepatitis B virus, Hepatitis C virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, Alpha 1 antitrypsin deficiency
- Secondary causes for steatosis: disorders of lipid metabolism, HCV Genotype 3, total parental nutrition, severe surgical weight loss, medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART)
- Celiac disease
- pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa Hospital
Istanbul
About this study
Official title: Efficacy of Isocaloric Mediterranean Diet and Low-fat Diet in Overweight/Obese MASLD Subjects With Respect to PNPLA3 Single Nucleotide Polymorphism: A Randomized Controlled Trial
The study is designed as a 12-week randomized controlled dietary intervention in individuals who had been diagnosed with NAFLD in the last 6 months and whose body mass index is above 25 at the time of participation in the pre-screening. The study sample is determined as 150 subjects and randomization will be done by stratification according to PNPLA3 genotype. At baseline, hepatic steatosis and fibrosis will be measured with Fibroscan, body composition will be analyzed, and transaminases and sugar and lipid metabolism indicators will be examined. The study will be conducted in parallel groups, with each group receiving equal amounts and intensity of Mediterranean diet or low-fat diet therapy. At the end of the 12-week intervention, baseline measurements will be repeated and the efficacy of the Mediterranean Diet and Low-fat diet therapies will be compared, as well as the effect of PNPLA3 mutation on intrahepatic response will be analyzed.
- Conditions
- NAFLD, Fatty Liver
- Being tested
- Dietary intervention
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionBehavioural
The dietary intervention is a personalized counselling programme implemented in form of a moderate caloric restriction (≈500 kcal/day) to allow for a moderate weight loss (≈5% BW). Each participant will be invited for consultation visits to a study dietitian, lasting up to 30 minutes. During the sessions, participants will be provided with written information material that explains the principles of diet in concern. Dietary interventions for both groups will be standardized in terms of education and one-on-one counseling. Education and dietary prescription will be individualized by the study dietitians within the diet-specific recommendations, to allow for personal food preferences. All subjects will receive equivalent intensity of care in terms of opportunities for contact and availability of individual dietary counseling. Motivational interviewing techniques and behavior change techniques will be adopted by study dietitians to ensure long-term maintenance of dietary modification.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet Group | Experimental | The Mediterranean diet includes high amounts of olive oil, olives, fruits, vegetables, whole grains, legumes, nuts, a high intake of fish, moderate consumption of eggs, poultry, and dairy, and low consumption of red meat and products. The targeted macronutrient distribution is 40% of total energy from carbohydrates, approximately 20% from protein, and 40% from fats. The share of saturated fats in total energy will not exceed 10%. Participants will be provided with written resources, brochures explaining the Mediterranean diet, and information about the Mediterranean diet pyramid. A weekly menu will be planned for all participants, along with cooking tips.
Participants in this group will receive a weekly food support package for 12 weeks, including essential elements of the Mediterranean diet such as olive oil, fish, nuts, and legumes. Receives: Behavioral: Dietary intervention |
| Low Fat Diet Group | Active comparator | The type of diet to be followed in this group is based on the recommendations of the American Heart Association, the American Diabetes Association guidelines, and the Specific Nutrition Guide for Turkey. The targeted macronutrient distribution will be 50% of total energy from carbohydrates, approximately 20% from protein, and less than 30% from fats. The share of saturated fats in total energy will not exceed 10%. Participants will be provided with information notes and brochures explaining the low-fat diet. A weekly menu will be planned for all participants, and cooking tips will be provided.
Participants in this group will receive a weekly food support package for 12 weeks, including low-fat dairy products, whole grains, and legumes, which are the essential elements of a low-fat diet. Receives: Behavioral: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in CAP (db/m)
The primary objective of this study is to determine the percentage decrease in hepatic steatosis at the end of week 12, measured by FibroScan® with CAP
Measured: 12 weeks
Decrease in Liver Stiffness (kPa)
The primary objective of this study is to determine the percentage decrease in hepatic fibrosis at the end of week 12, measured by FibroScan® with E
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start19 Oct 2023
- Primary completion18 Oct 2024 (estimated)
- Study completion18 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor
- Investigators
- Zeynep Banu Gungor, Prof, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220695
- Sponsor's protocol ID
- UMCRPS-23-1
- Status last verified
- Apr 2024
- First submitted
- 15 Jan 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Isocaloric Mediterranean Diet and Low-fat Diet in Overweight/Obese MASLD Subjects With Respect to PNPLA3 Single Nucleotide Polymorphism: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06220695
- Acronym / sponsor ID
- UMCRPS-23-1
- Conditions
- NAFLD, Fatty Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 18 Oct 2024 (estimated)
- Study completion
- 18 Oct 2024 (estimated)
- First posted
- 24 Jan 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 study is designed as a 12-week randomized controlled dietary intervention in individuals who had been diagnosed with NAFLD in the last 6 months and whose body mass index is above 25 at the time of participation in the pre-screening. The study sample is determined as 150 subjects and randomization will be done by stratification according to PNPLA3 genotype. At baseline, hepatic steatosis and fibrosis will be measured with Fibroscan, body composition will be analyzed, and transaminases and sugar and lipid metabolism indicators will be examined. The study will be conducted in parallel groups, with each group receiving equal amounts and intensity of Mediterranean diet or low-fat diet therapy. At the end of the 12-week intervention, baseline measurements will be repeated and the efficacy of the Mediterranean Diet and Low-fat diet therapies will be compared, as well as the effect of PNPLA3 mutation on intrahepatic response will be analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet Group | Experimental | Behavioral: Dietary interventionThe Mediterranean diet includes high amounts of olive oil, olives, fruits, vegetables, whole grains, legumes, nuts, a high intake of fish, moderate consumption of eggs, poultry, and dairy, and low consumption of red meat and products. The targeted macronutrient distribution is 40% of total energy from carbohydrates, approximately 20% from protein, and 40% from fats. The share of saturated fats in total energy will not exceed 10%. Participants will be provided with written resources, brochures explaining the Mediterranean diet, and information about the Mediterranean diet pyramid. A weekly menu will be planned for all participants, along with cooking tips. Participants in this group will receive a weekly food support package for 12 weeks, including essential elements of the Mediterranean diet such as olive oil, fish, nuts, and legumes. |
| Low Fat Diet Group | Active comparator | Behavioral: Dietary interventionThe type of diet to be followed in this group is based on the recommendations of the American Heart Association, the American Diabetes Association guidelines, and the Specific Nutrition Guide for Turkey. The targeted macronutrient distribution will be 50% of total energy from carbohydrates, approximately 20% from protein, and less than 30% from fats. The share of saturated fats in total energy will not exceed 10%. Participants will be provided with information notes and brochures explaining the low-fat diet. A weekly menu will be planned for all participants, and cooking tips will be provided. Participants in this group will receive a weekly food support package for 12 weeks, including low-fat dairy products, whole grains, and legumes, which are the essential elements of a low-fat diet. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to understand and sign informed consent
- BMI> 25 kg/m2
- Between 18-80 years
- previous clinical diagnosis of MASLD by abdominal USG, MRI, FibroScan® or liver biopsy
Key exclusion criteria (5 listed)
- Excessive alcohol use (more than 20 g/day for women and 30g/day for men= >2 units alcohol/day for women and >3 units for men)
- Other liver diseases: Hepatitis B virus, Hepatitis C virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, Alpha 1 antitrypsin deficiency
- Secondary causes for steatosis: disorders of lipid metabolism, HCV Genotype 3, total parental nutrition, severe surgical weight loss, medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART)
- Celiac disease
- pregnancy and breastfeeding
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 |
|---|---|---|
| Dietary interventionThe dietary intervention is a personalized counselling programme implemented in form of a moderate caloric restriction (≈500 kcal/day) to allow for a moderate weight loss (≈5% BW). Each participant will be invited for consultation visits to a study dietitian, lasting up to 30 minutes. During the sessions, participants will be provided with written information material that explains the principles of diet in concern. Dietary interventions for both groups will be standardized in terms of education and one-on-one counseling. Education and dietary prescription will be individualized by the study dietitians within the diet-specific recommendations, to allow for personal food preferences. All subjects will receive equivalent intensity of care in terms of opportunities for contact and availability of individual dietary counseling. Motivational interviewing techniques and behavior change techniques will be adopted by study dietitians to ensure long-term maintenance of dietary modification. | Behavioural | Low Fat Diet Group, Mediterranean Diet Group |
Primary outcome
Decrease in CAP (db/m)
Time frame: 12 weeks
The primary objective of this study is to determine the percentage decrease in hepatic steatosis at the end of week 12, measured by FibroScan® with CAP
Decrease in Liver Stiffness (kPa)
Time frame: 12 weeks
The primary objective of this study is to determine the percentage decrease in hepatic fibrosis at the end of week 12, measured by FibroScan® with E
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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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.
Zeynep Banu Gungor, Prof principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with NAFLD and Fatty Liver, run by Maastricht 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 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: status not confirmed, as of the sponsor's last update on 15 Apr 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?
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?
Decrease in CAP (db/m) (time frame: 12 weeks). The study lists 2 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 15 Apr 2024.