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Aronia and Non-alcoholic Fatty Liver Disease

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06450769
Enrollment
54
Registered
2024-06-10
Start date
2024-06-15
Completion date
2026-06-15
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Aronia, NAFLD, Mediterranean diet, Oxidative stress, Inflammation, Microbiota

Brief 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. 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.

Interventions

100% aronia juice, 100 mL/day, twelve-week follow-up

OTHERMediterranean diet

An individually planned nutrition program suitable for the energy-restricted Mediterranean diet

OTHERLow-fat diet

An individually planned nutrition program suitable for the energy-restricted low-fat diet

Sponsors

Istanbul Kent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* 18- 64 years of age * Body mass index (BMI) 25-40 kg/m2 * Newly diagnosed with NAFLD and has not been treated before * Volunteering

Exclusion criteria

* Chronic disease other than NAFLD * Pregnancy or breastfeeding * Bleeding disorder * Regular medication use * Any food allergies or intolerances * Being on a special diet treatment * 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

Design outcomes

Primary

MeasureTime frameDescription
Oxidative stressBaseline and end of the 12th weekTAS, TOS, SOD, Malondialdehyde (MDA), Catalase, Glutathione peroxidase, Glutathione, AGE and DNA oxidative damage will be evaluated.
InflammationBaseline and end of the 12th weekCRP, TNF-alfa, IL-10, IL-13, IL-17, IL-23, TGF-β, LPS will be evaluated.
Degree of hepatic steatosisBaseline and end of the 12th weekEvaluation of hepatic steatosis by liver ultrasonography
Microbiota analysisBaseline and end of the 12th week16s rRNA Gene Sequencing and Compositional Analyzes
Body composition analysisBaseline, every 15 days and end of the 12th weekBody weight, height and body composition, waist, hip and neck circumference measurements

Contacts

Primary ContactGamze Akbulut
gamze.akbulut@kent.edu.tr+90 0212 610 10 10
Backup ContactFeride Ayyıldız
feridecelebi@gazi.edu.tr+90 312 216 2674

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026