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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Mediterranean diet; Other: Aronia juice; Other: Low-fat diet

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gamze Akbulut; Phone Number: +90 0212 610 10 10; Email: gamze.akbulut@kent.edu.tr
• Study Contact Backup: Name: Feride Ayyıldız; Phone Number: +90 312 216 2674; Email: feridecelebi@gazi.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean diet group; An individually planned nutrition program suitable for the energy-restricted Mediterranean diet will be created for individuals in this group.	Other: Mediterranean diet; An individually planned nutrition program suitable for the energy-restricted Mediterranean diet
Experimental: 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.	Other: Mediterranean diet; An individually planned nutrition program suitable for the energy-restricted Mediterranean diet; Other: Aronia juice; 100% aronia juice, 100 mL/day, twelve-week follow-up
Experimental: 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.	Other: Low-fat diet; An individually planned nutrition program suitable for the energy-restricted low-fat diet
Experimental: 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.	Other: Aronia juice; 100% aronia juice, 100 mL/day, twelve-week follow-up; Other: Low-fat diet; An individually planned nutrition program suitable for the energy-restricted low-fat diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative stress	TAS, TOS, SOD, Malondialdehyde (MDA), Catalase, Glutathione peroxidase, Glutathione, AGE and DNA oxidative damage will be evaluated.	Baseline and end of the 12th week
Inflammation	CRP, TNF-alfa, IL-10, IL-13, IL-17, IL-23, TGF-β, LPS will be evaluated.	Baseline and end of the 12th week
Degree of hepatic steatosis	Evaluation of hepatic steatosis by liver ultrasonography	Baseline and end of the 12th week
Microbiota analysis	16s rRNA Gene Sequencing and Compositional Analyzes	Baseline and end of the 12th week
Body composition analysis	Body weight, height and body composition, waist, hip and neck circumference measurements	Baseline, every 15 days and end of the 12th week

Collaborators and Investigators

• Sponsor: Istanbul Kent University
• Investigators: Study Director: Gamze Akbulut, Kent University; Principal Investigator: Tarkan Karakan, Gazi University; Principal Investigator: Ali Karataş, Gazi University; Principal Investigator: Emine Yassıbaş, Gazi University; Principal Investigator: Feride Ayyıldız, Gazi University; Principal Investigator: Büşra Atabilen, Karamanoglu Mehmetbey University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Oxidative stress; Inflammation; Microbiota; NAFLD; Mediterranean diet; Aronia
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 222S452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No