Aronia and Non-alcoholic Fatty Liver Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorIstanbul Kent University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18- 64 years of age

Body mass index (BMI) 25-40 kg/m2

Newly diagnosed with NAFLD and has not been treated before

Volunteering

Disqualifiers

Chronic disease other than NAFLD

Pregnancy or breastfeeding

Bleeding disorder

Regular medication use

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aronia juice

    Other intervention

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

  • Mediterranean diet

    Other intervention

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

  • Low-fat diet

    Other intervention

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

Treatment groups

54 Participants
are divided into 4 treatment groups
Group A: Mediterranean diet groupExperimental treatment 1 intervention
Group B: Mediterranean diet supplemented with aronia groupExperimental treatment 2 interventions
Group C: Low-fat diet groupExperimental treatment 1 intervention
Group D: Low-fat diet supplemented with aronia groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Oxidative stress

TAS, TOS, SOD, Malondialdehyde (MDA), Catalase, Glutathione peroxidase, Glutathione, AGE and DNA oxidative damage will be evaluated.

Time frame
Baseline and end of the 12th week
2

Inflammation

CRP, TNF-alfa, IL-10, IL-13, IL-17, IL-23, TGF-β, LPS will be evaluated.

Time frame
Baseline and end of the 12th week
3

Degree of hepatic steatosis

Evaluation of hepatic steatosis by liver ultrasonography

Time frame
Baseline and end of the 12th week
4

Microbiota analysis

16s rRNA Gene Sequencing and Compositional Analyzes

Time frame
Baseline and end of the 12th week

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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