Aronia and Non-alcoholic Fatty Liver Disease

NCT06450769 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-06-10

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06450769 on ClinicalTrials.gov