About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18- 64 years of age
Body mass index (BMI) 25-40 kg/m2
Newly diagnosed with NAFLD and has not been treated before
Volunteering
Disqualifiers
Chronic disease other than NAFLD
Pregnancy or breastfeeding
Bleeding disorder
Regular medication use
Trial design
Parallel
Treatments tested in this trial
Aronia juice
Other intervention100% aronia juice, 100 mL/day, twelve-week follow-up
Mediterranean diet
Other interventionAn individually planned nutrition program suitable for the energy-restricted Mediterranean diet
Low-fat diet
Other interventionAn individually planned nutrition program suitable for the energy-restricted low-fat diet
Treatment groups
Trial outcomes
Primary outcomes
Oxidative stress
TAS, TOS, SOD, Malondialdehyde (MDA), Catalase, Glutathione peroxidase, Glutathione, AGE and DNA oxidative damage will be evaluated.
Inflammation
CRP, TNF-alfa, IL-10, IL-13, IL-17, IL-23, TGF-β, LPS will be evaluated.
Degree of hepatic steatosis
Evaluation of hepatic steatosis by liver ultrasonography
Microbiota analysis
16s rRNA Gene Sequencing and Compositional Analyzes
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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