Aronia and Non-alcoholic Fatty Liver Disease
NCT06450769 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2024-06-10
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.
Conditions
- Non-Alcoholic Fatty Liver Disease
Interventions
- OTHER
-
Aronia juice
100% aronia juice, 100 mL/day, twelve-week follow-up
- OTHER
-
Mediterranean diet
An individually planned nutrition program suitable for the energy-restricted Mediterranean diet
- OTHER
-
Low-fat diet
An individually planned nutrition program suitable for the energy-restricted low-fat diet
Sponsors & Collaborators
-
Istanbul Kent University
lead OTHER
Principal Investigators
-
Gamze Akbulut · Kent University
-
Tarkan Karakan · Gazi University
-
Ali Karataş · Gazi University
-
Emine Yassıbaş · Gazi University
-
Feride Ayyıldız · Gazi University
-
Büşra Atabilen · Karamanoğlu Mehmetbey University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-15
- Primary Completion
- 2025-09-15
- Completion
- 2026-06-15
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