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Effects of naringenin supplementation in overweight/obese patients with non-alcoholic fatty liver disease: study protocol for a randomized double-blind clinical trial
- Source :
- Trials, Vol 22, Iss 1, Pp 1-9 (2021), Trials
- Publication Year :
- 2021
-
Abstract
- Introduction Non-alcoholic fatty liver disease (NAFLD) is one of the main causes of chronic liver disease worldwide. Flavonoids, a group of natural compounds, have garnered a great deal of attention in the management of NAFLD because of their profitable effects on glucose and lipid metabolism, inflammation, and oxidative stress which are the pivotal pathophysiological pathways in NAFLD. Naringenin is a citrus-derived flavonoid with a broad spectrum of potential biological effects including anti-inflammatory and antioxidant properties, which may exert protective effects against NAFLD. The present clinical trial aims to examine the efficacy of naringenin supplementation on plasma adiponectin and neurogulin-4 (NRG-4) concentrations, metabolic parameters, and liver function indices in overweight/obese patients with NAFLD. Methods and analysis This is a double-blind, randomized, placebo-controlled clinical study that will investigate the impacts of naringenin supplementation in overweight/obese patients with NAFLD. Liver ultrasonography will be applied to diagnose NAFLD. Forty-four eligible overweight/obese subjects with NAFLD will be selected and randomly assigned to receive naringenin capsules or identical placebo (each capsule contains 100 mg of naringenin or cellulose), twice daily for 4 weeks. Participants will be asked to remain on their usual diet and physical activity. Safety of naringenin supplementation was confirmed by the study pharmacist. The primary outcome of this study is changes in adiponectin circulating levels. The secondary outcomes include changes in NRG-4 levels, liver function indices, metabolic parameters, body weight, body mass index (BMI), waist circumference (WC), blood pressure, and hematological parameters. Statistical analysis will be conducted using the SPSS software (version 25), and P value less than 0.05 will be regarded as statistically significant. Discussion We hypothesize that naringenin administration may be useful for treating NAFLD by modulating energy balance, glucose and lipid metabolism, oxidative stress, and inflammation through different mechanisms. The current trial will exhibit the effects of naringenin, whether negative or positive, on NAFLD status. Ethical aspects The current trial received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICNE.REC.1399.439). Trial registration Iranian Registry of Clinical Trials IRCT201311250155336N12. Registered on 6 June 2020
- Subjects :
- Naringenin
medicine.medical_specialty
Medicine (General)
Medicine (miscellaneous)
Overweight
Iran
Chronic liver disease
Gastroenterology
Study Protocol
chemistry.chemical_compound
R5-920
Double-Blind Method
Non-alcoholic Fatty Liver Disease
Internal medicine
medicine
Humans
Pharmacology (medical)
Obesity
education
Metabolic parameters
Randomized Controlled Trials as Topic
Neuregulin-4
education.field_of_study
Adiponectin
business.industry
Fatty liver
nutritional and metabolic diseases
food and beverages
Non-alcoholic-fatty liver disease
medicine.disease
chemistry
Dietary Supplements
Flavanones
Liver function
medicine.symptom
business
Body mass index
Subjects
Details
- ISSN :
- 17456215
- Volume :
- 22
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....f84476613ff91b590d88d07610f30058