Non-Alcoholic Fatty Liver DiseaseNCT06450769
Aronia and Non-alcoholic Fatty Liver Disease
A study testing Aronia juice, Mediterranean diet and Low-fat diet in people with Non-Alcoholic Fatty Liver Disease, run by Istanbul Kent University.
Trial summary
Adults newly diagnosed with NAFLD will be included in the study. At the beginning of the research, the socio-demographic characteristics and nutritional habits of the individuals will be questioned with a face-to-face questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Aronia juice, Mediterranean diet and Low-fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 15 Jun 2026
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18- 64 years of age
- Body mass index (BMI) 25-40 kg/m2
- Newly diagnosed with NAFLD and has not been treated before
- Volunteering
Who cannot join
- Chronic disease other than NAFLD
- Pregnancy or breastfeeding
- Bleeding disorder
- Regular medication use
- Any food allergies or intolerances
- Being on a special diet treatment
Show all 13Show fewer
- Smoking in the last year
- Alcohol use in the last year
- Having used antibiotics in the last 3 months
- Use of prebiotics or probiotics in the last 3 months
- Use of proton pump inhibitors in the last 3 months
- Use of vitamin-mineral supplementation in the last 3 months
- Use of nutritional supplements in the last 3 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Mediterranean Diet Supplemented With Aronia and Low-Fat Diet on Hepatic Steatosis, Inflammation, Oxidative Stress and Microbiota in Non-alcoholic Fatty Liver Disease
Adults newly diagnosed with NAFLD will be included in the study. At the beginning of the research, the socio-demographic characteristics and nutritional habits of the individuals will be questioned with a face-to-face questionnaire. In addition, at the beginning of the study, blood samples, 3-day food consumption record, physical activity record, anthropometric measurements (height, body weight, waist, hip and neck circumference and body composition analysis) and stool samples will be taken from the patients. Oxidative stress (TAS, TOS, SOD, Malondialdehyde, Catalase, Glutathione peroxidase, Glutathione, AGE and DNA oxidative damage) and inflammation (CRP, TNF-alpha, IL-17, IL-23, IL-10, IL-13, TGF-beta) parameters in blood samples will be analyzed. Patients will then be randomized into four groups to follow a Mediterranean diet supplemented with aronia, a Mediterranean diet, a low-fat diet supplemented with aronia, or a low-fat diet. Necessary training will be given to the participants so that they can apply the individually planned diet. Dietary adherence and anthropometric measurements will be evaluated every 2 weeks. At the end of the twelve-week follow-up, all parameters evaluated at the beginning of the study will be repeated and compared with previous values.
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is a chronic liver disease in which more than 5% fat accumulation in the liver (steatosis). It has become the most common liver disease in adults with the effect of obesity. In fact, NAFLD is seen in approximately 25% of adults. If left untreated, it can progress to cirrhosis, hepatocellular carcinoma, and end-stage liver failure. It is obvious that it is necessary to identify preventive factors for NAFLD and to develop new approaches for its treatment. There is an increase in inflammation and oxidative stress levels in NAFLD, which is important for the development of possible treatment methods. In this study, the Mediterranean diet supplemented with aronia is expected to contribute positively to progression of the disease by improving inflammation and oxidative stress parameters. Adding aronia to the Mediterranean diet will increase the polyphenol content of this diet. This study was planned with the thought that a Mediterranean diet supplemented with aronia will have positive effects on hepatic steatosis, oxidative stress, inflammation, and microbiota in NAFLD, where lifestyle changes, including healthy nutrition, are included in the primary treatment.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Aronia juice, Mediterranean diet, Low-fat diet
- Keywords
- Aronia, NAFLD, Mediterranean diet, Oxidative stress, Inflammation, Microbiota
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aronia juiceOther
100% aronia juice, 100 mL/day, twelve-week follow-up
Mediterranean dietOther
An individually planned nutrition program suitable for the energy-restricted Mediterranean diet
Low-fat dietOther
An individually planned nutrition program suitable for the energy-restricted low-fat diet
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet group | Experimental | An individually planned nutrition program suitable for the energy-restricted Mediterranean diet will be created for individuals in this group. Receives: Other: Mediterranean diet |
| Mediterranean diet supplemented with aronia group | Experimental | An individually planned nutrition program suitable for the energy-restricted Mediterranean diet will be created for individuals in this group. Also 100 mL/day of 100% aronia juice will be given. Receives: Other: Aronia juice; Other: Mediterranean diet |
| Low-fat diet group | Experimental | An individually planned nutrition program suitable for the energy-restricted low-fat diet will be created for individuals in this group. Receives: Other: Low-fat diet |
| Low-fat diet supplemented with aronia group | Experimental | An individually planned nutrition program suitable for the energy-restricted low-fat diet will be created for individuals in this group. Also 100 mL/day of 100% aronia juice will be given. Receives: Other: Aronia juice; Other: Low-fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress
TAS, TOS, SOD, Malondialdehyde (MDA), Catalase, Glutathione peroxidase, Glutathione, AGE and DNA oxidative damage will be evaluated.
Measured: Baseline and end of the 12th week
Inflammation
CRP, TNF-alfa, IL-10, IL-13, IL-17, IL-23, TGF-β, LPS will be evaluated.
Measured: Baseline and end of the 12th week
Degree of hepatic steatosis
Evaluation of hepatic steatosis by liver ultrasonography
Measured: Baseline and end of the 12th week
Microbiota analysis
16s rRNA Gene Sequencing and Compositional Analyzes
Measured: Baseline and end of the 12th week
Body composition analysis
Body weight, height and body composition, waist, hip and neck circumference measurements
Measured: Baseline, every 15 days and end of the 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Kent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Akbulut, Istanbul Kent University
- Investigators
- Gamze Akbulut, Study director, Kent UniversityTarkan Karakan, Principal investigator, Gazi UniversityAli Karataş, Principal investigator, Gazi UniversityEmine Yassıbaş, Principal investigator, Gazi UniversityFeride Ayyıldız, Principal investigator, Gazi UniversityBüşra Atabilen, Principal investigator, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450769
- Sponsor's protocol ID
- 222S452
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- 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 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mediterranean Diet Supplemented With Aronia and Low-Fat Diet on Hepatic Steatosis, Inflammation, Oxidative Stress and Microbiota in Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06450769
- Acronym / sponsor ID
- 222S452
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Aronia, NAFLD, Mediterranean diet, Oxidative stress, Inflammation, Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Istanbul Kent UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 10 Jun 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.
Adults newly diagnosed with NAFLD will be included in the study. At the beginning of the research, the socio-demographic characteristics and nutritional habits of the individuals will be questioned with a face-to-face questionnaire. In addition, at the beginning of the study, blood samples, 3-day food consumption record, physical activity record, anthropometric measurements (height, body weight, waist, hip and neck circumference and body composition analysis) and stool samples will be taken from the patients. Oxidative stress (TAS, TOS, SOD, Malondialdehyde, Catalase, Glutathione peroxidase, Glutathione, AGE and DNA oxidative damage) and inflammation (CRP, TNF-alpha, IL-17, IL-23, IL-10, IL-13, TGF-beta) parameters in blood samples will be analyzed. Patients will then be randomized into four groups to follow a Mediterranean diet supplemented with aronia, a Mediterranean diet, a low-fat diet supplemented with aronia, or a low-fat diet. Necessary training will be given to the participants so that they can apply the individually planned diet. Dietary adherence and anthropometric measurements will be evaluated every 2 weeks. At the end of the twelve-week follow-up, all parameters evaluated at the beginning of the study will be repeated and compared with previous values.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is a chronic liver disease in which more than 5% fat accumulation in the liver (steatosis). It has become the most common liver disease in adults with the effect of obesity. In fact, NAFLD is seen in approximately 25% of adults. If left untreated, it can progress to cirrhosis, hepatocellular carcinoma, and end-stage liver failure. It is obvious that it is necessary to identify preventive factors for NAFLD and to develop new approaches for its treatment. There is an increase in inflammation and oxidative stress levels in NAFLD, which is important for the development of possible treatment methods. In this study, the Mediterranean diet supplemented with aronia is expected to contribute positively to progression of the disease by improving inflammation and oxidative stress parameters. Adding aronia to the Mediterranean diet will increase the polyphenol content of this diet. This study was planned with the thought that a Mediterranean diet supplemented with aronia will have positive effects on hepatic steatosis, oxidative stress, inflammation, and microbiota in NAFLD, where lifestyle changes, including healthy nutrition, are included in the primary treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet group | Experimental | Other: Mediterranean dietAn individually planned nutrition program suitable for the energy-restricted Mediterranean diet will be created for individuals in this group. |
| Mediterranean diet supplemented with aronia group | Experimental | Other: Aronia juice, Other: Mediterranean dietAn individually planned nutrition program suitable for the energy-restricted Mediterranean diet will be created for individuals in this group. Also 100 mL/day of 100% aronia juice will be given. |
| Low-fat diet group | Experimental | Other: Low-fat dietAn individually planned nutrition program suitable for the energy-restricted low-fat diet will be created for individuals in this group. |
| Low-fat diet supplemented with aronia group | Experimental | Other: Aronia juice, Other: Low-fat dietAn individually planned nutrition program suitable for the energy-restricted low-fat diet will be created for individuals in this group. Also 100 mL/day of 100% aronia juice will be given. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18- 64 years of age
- Body mass index (BMI) 25-40 kg/m2
- Newly diagnosed with NAFLD and has not been treated before
- Volunteering
Key exclusion criteria (13 listed)
- Chronic disease other than NAFLD
- Pregnancy or breastfeeding
- Bleeding disorder
- Regular medication use
- Any food allergies or intolerances
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 |
|---|---|---|
| Aronia juice100% aronia juice, 100 mL/day, twelve-week follow-up | Other | Low-fat diet supplemented with aronia group, Mediterranean diet supplemented with aronia group |
| Mediterranean dietAn individually planned nutrition program suitable for the energy-restricted Mediterranean diet | Other | Mediterranean diet group, Mediterranean diet supplemented with aronia group |
| Low-fat dietAn individually planned nutrition program suitable for the energy-restricted low-fat diet | Other | Low-fat diet group, Low-fat diet supplemented with aronia group |
Primary outcome
Oxidative stress
Time frame: Baseline and end of the 12th week
TAS, TOS, SOD, Malondialdehyde (MDA), Catalase, Glutathione peroxidase, Glutathione, AGE and DNA oxidative damage will be evaluated.
Inflammation
Time frame: Baseline and end of the 12th week
CRP, TNF-alfa, IL-10, IL-13, IL-17, IL-23, TGF-β, LPS will be evaluated.
Degree of hepatic steatosis
Time frame: Baseline and end of the 12th week
Evaluation of hepatic steatosis by liver ultrasonography
Microbiota analysis
Time frame: Baseline and end of the 12th week
16s rRNA Gene Sequencing and Compositional Analyzes
Body composition analysis
Time frame: Baseline, every 15 days and end of the 12th week
Body weight, height and body composition, waist, hip and neck circumference measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 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.
Gamze Akbulut study director
Kent University
Tarkan Karakan principal investigator
Gazi University
Ali Karataş principal investigator
Gazi University
Questions about this trial
What is this clinical trial studying?
A study testing Aronia juice, Mediterranean diet and Low-fat diet in people with Non-Alcoholic Fatty Liver Disease, run by Istanbul Kent University.
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 13 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 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Gamze Akbulut (+90 0212 610 10 10, gamze.akbulut@kent.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative stress (time frame: Baseline and end of the 12th week). The study lists 5 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 10 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.