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Effect of Naringenin Supplementation on Inflammation in Patients with Non-Alcoholic Fatty Liver Disease

Evaluation of the Effect of Naringenin Supplementation on Inflammatory Factors in Patients with Non-Alcoholic Fatty Liver Disease: A Randomized Double-Blind Clinical Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251116068017N1
Enrollment
200
Registered
2025-12-13
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD), a metabolic liver disorder characterized by hepatic steatosis, chronic inflammation, and risk of fibrosis and cirrhosis. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Participants will receive daily oral supplementation with 2 capsules of naringenin (each capsule containing 200 mg naringenin + 300 mg starch) for 3 months. Capsules will be taken ever

Sponsors

Shahre-kord University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 20–65 years Body mass index between 25 and 35 kg/m² Diagnosis of NAFLD confirmed by ultrasound Written informed consent

Exclusion criteria

Exclusion criteria: Use of herbal supplements, antioxidants, omega-3, probiotics, or multivitamins in the past three months Use of NSAIDs, antibiotics, corticosteroids, or weight-loss medications Pregnancy or breastfeeding Menopause Substance or alcohol abuse Liver pathologic disorders, viral hepatitis, or liver transplantation Diabetes, gastrointestinal diseases, organ failure, thyroid disorders, kidney diseases, autoimmune disorders Severe psychiatric disorders or cardiovascular events in the past three months Any malignancy

Design outcomes

Primary

MeasureTime frame
Serum C-reactive protein (CRP) level in patients with non-alcoholic fatty liver disease (NAFLD). Timepoint: Baseline (before intervention) and at 3 months after daily naringenin supplementation. Method of measurement: Serum CRP measured using standard laboratory immunoassay kits.

Secondary

MeasureTime frame
Inflammatory factor related to immune response. Timepoint: Baseline and 12-week follow-up. Method of measurement: Serum levels measured using standard enzyme-linked immunosorbent assay kits.;Second inflammatory factor related to immune response. Timepoint: Baseline and 12-week follow-up. Method of measurement: Serum levels measured using standard enzyme-linked immunosorbent assay kits.;Low-density lipoprotein. Timepoint: Baseline and 12-week follow-up. Method of measurement: Measured using standard enzymatic colorimetric laboratory kits.;High-density lipoprotein. Timepoint: Baseline and 12-week follow-up. Method of measurement: Measured using standard enzymatic colorimetric laboratory kits.;Participant adherence. Timepoint: Midpoint and end of study. Method of measurement: Counting remaining capsules and calculating adherence percentage.;Adverse events. Timepoint: Throughout the intervention period. Method of measurement: Self-reported events recorded at each follow-up visit and via structured questionnaires.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Karami horestani

Shahre-kord University of Medical Sciences

karami.m@skums.ac.ir+98 913 101 7143

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026