Clinical trial NCT06450769: Aronia and Non-alcoholic Fatty Liver Disease
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Aronia
NAFLD
Mediterranean diet
Oxidative stress
Inflammation
Microbiota
Lead sponsor: Istanbul Kent University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Oxidative stress
timeFrame: Baseline and end of the 12th week
measure: Inflammation
timeFrame: Baseline and end of the 12th week
measure: Degree of hepatic steatosis
timeFrame: Baseline and end of the 12th week
measure: Microbiota analysis
timeFrame: Baseline and end of the 12th week
measure: Body composition analysis
timeFrame: Baseline, every 15 days and end of the 12th week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kent University
name: Gamze Akbulut
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Tarkan Karakan
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Ali Karataş
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Emine Yassıbaş
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Feride Ayyıldız
role: PRINCIPAL_INVESTIGATOR
affiliation: Karamanoğlu Mehmetbey University
name: Büşra Atabilen
role: PRINCIPAL_INVESTIGATOR
References: