Aronia and Non-alcoholic Fatty Liver Disease

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450769
• Other study ID #: 222S452
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: June 15, 2026

Study information

• Verified date: June 2024
• Source: Istanbul Kent University
• Contact: Gamze Akbulut
• Phone: +90 0212 610 10 10
• Email: gamze.akbulut[@]kent.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: June 15, 2026
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Other:
• Aronia juice
100% aronia juice, 100 mL/day, twelve-week follow-up
• Mediterranean diet
An individually planned nutrition program suitable for the energy-restricted Mediterranean diet
• Low-fat diet
An individually planned nutrition program suitable for the energy-restricted low-fat diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Kent University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Inflammation	CRP, TNF-alfa, IL-10, IL-13, IL-17, IL-23, TGF-ß, LPS will be evaluated.	Baseline and end of the 12th week
Primary	Degree of hepatic steatosis	Evaluation of hepatic steatosis by liver ultrasonography	Baseline and end of the 12th week
Primary	Microbiota analysis	16s rRNA Gene Sequencing and Compositional Analyzes	Baseline and end of the 12th week
Primary	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