Aronia and Non-alcoholic Fatty Liver Disease

NCT06450769 | Not Yet Recruiting

• 1 other identifier: 222S452
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Aronia; NAFLD; Mediterranean diet; Oxidative stress; Inflammation; Microbiota

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

Mediterranean diet group

EXPERIMENTAL

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

Other: Mediterranean diet

Mediterranean diet supplemented with aronia group

EXPERIMENTAL

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: Aronia juice; Other: Mediterranean diet

Low-fat diet group

EXPERIMENTAL

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

Low-fat diet supplemented with aronia group

EXPERIMENTAL

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; Other: Low-fat diet

Interventions

Aronia juice OTHER

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

Low-fat diet supplemented with aronia group; Mediterranean diet supplemented with aronia group

Mediterranean diet OTHER

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

Mediterranean diet group; Mediterranean diet supplemented with aronia group

Low-fat diet OTHER

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

Low-fat diet group; Low-fat diet supplemented with aronia group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Body mass index (BMI) 25-40 kg/m2
• Newly diagnosed with NAFLD and has not been treated before
• Volunteering

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Kent University: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Inflammation

Interventions

Diet, Mediterranean; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Gamze Akbulut

  Kent University

  STUDY DIRECTOR

• 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

  Karamanoğlu Mehmetbey University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamze Akbulut

CONTACT

+90 0212 610 10 10; gamze.akbulut@kent.edu.tr

Feride Ayyıldız

CONTACT

+90 312 216 2674; feridecelebi@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 10, 2024
• Study Start: June 15, 2024
• Primary Completion: September 15, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share