The effect of chitosan supplementation on changes of weight, glycemic risk factors, lipid profile, serum inflammatory factors, adipokines and total antioxidant capacity in patients with nonalcoholic fatty liver disease (NAFLD)

The effect of chitosan supplementation on changes of weight, glycemic risk factors, lipid profile, serum inflammatory factors, adipokines and total antioxidant capacity in patients with nonalcoholic fatty liver disease (NAFLD)

A clinical trial with control group (n=50), with parallel groups, double blind, randomized

This is a clinical trial study performed on Fatty liver patients referred to Golestan Hospital in 1397. The inform consent is given to the participants. Then, a 3-part questionnaire is completed by the subjects. Blood samples are collected at baseline and 12 weeks after the study. Study participants, the main researcher, the specialist, the person who collects the data and analyzes the outcomes are blinded.

Inclusion criteria: Individuals aged between 18-65 years of both genders; diagnosis of nonalcoholic fatty liver disease by ultrasound; willingness to participate Exclusion criteria: Suffering from other kinds of liver disease, diseases that involves bile ducts, hypothyroidism, lipodystrophy, ; history of chronic liver disease, cardiovascular and renal disease; history of significant weight loss (more than 10% of body weight during 6 months ago) or weight loss surgery; history of antioxidant supplementation, omega 3 and milk thistle during 6 months ago; history of liver damaging drug; history of; alcohol consumption more than 20 gram per day, pregnancy and lactation; menopause; energy consumption less than 800 or more than 4200 kilocalorie per day

Intervention group: patients with nonalcoholic fatty liver, 18 to 65 years, receiving chitosan supplements for 12 weeks Control group:patients with nonalcoholic fatty liver, 18 to 65 years, receiving placebo for 12 weeks

glycated hemoglobin; fasting blood glucose; insulin; TNF-α; IL-6; adiponectin; leptin; TAC

First, a nonrandom sample is chosen among the individuals ,who has the inclusion criteria, using a simple sampling method. Then, the randomization is performed between study groups. One of the hospital nurses ,who has not been blinded in the study, will change the names of chitosan and placebo on their packages to A and B (for example). Then, the researcher will distribute A and B packages among patients, who are referring to Golestan Hospital, using a randomized block method (ABAB, BABA, AABB, BBAA, ABBA, BAAB; A, first person; B, Second person; A, third person; B,fourth person B etc.). Finally, choosing the blocks will be continued until reaching the sample size.

Study participants, the main researcher, the specialist, the person who collects the data and analyzes the outcomes are blinded. Supplement and placebo are the same in shape and color, so study participants will not be aware of supplements’ content. One of the nurses in hospital will change the names of chitosan and placebo on their packages to A and B, so the main researcher will not be aware of supplements’ content that are given to the patients. The specialist, the person who collects the data (the main researcher) and analyzes the outcomes (the main researcher) will not be aware of supplements’ content.