Aronia and Non-alcoholic Fatty Liver Disease

NCT ID: NCT06450769

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2026-06-15

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Mediterranean diet group

An individually planned nutrition program suitable for the energy-restricted Mediterranean diet will be created for individuals in this group.

Group Type: EXPERIMENTAL

Mediterranean diet

Intervention Type: OTHER

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

Mediterranean diet supplemented with aronia group

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.

Group Type: EXPERIMENTAL

Aronia juice

Intervention Type: OTHER

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

Mediterranean diet

Intervention Type: OTHER

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

Low-fat diet group

An individually planned nutrition program suitable for the energy-restricted low-fat diet will be created for individuals in this group.

Group Type: EXPERIMENTAL

Low-fat diet

Intervention Type: OTHER

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

Low-fat diet supplemented with aronia group

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.

Group Type: EXPERIMENTAL

Aronia juice

Intervention Type: OTHER

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

Low-fat diet

Intervention Type: OTHER

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

Interventions

Aronia juice

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

Intervention Type: OTHER

Mediterranean diet

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

Intervention Type: OTHER

Low-fat diet

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Kent University

OTHER

Sponsor Role: lead

Responsible Party

Gamze Akbulut

Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gamze Akbulut

Role: STUDY_DIRECTOR

Kent University

Tarkan Karakan

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Ali Karataş

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Emine Yassıbaş

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Feride Ayyıldız

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Büşra Atabilen

Role: PRINCIPAL_INVESTIGATOR

Karamanoğlu Mehmetbey University

Central Contacts

Gamze Akbulut

Role: CONTACT

gamze.akbulut@kent.edu.tr

+90 0212 610 10 10

Feride Ayyıldız

Role: CONTACT

feridecelebi@gazi.edu.tr

+90 312 216 2674

Other Identifiers

222S452

Identifier Type: -

Identifier Source: org_study_id