Assessing the synergistic effect of milk thistle extract, curcumin, n-acetylcystein, artichoke extract, vitamin D, and Chromium compared to placebo on liver function in patients with non-alcoholic fatty liver (NAFLD)

Determinig the synergistic effects of milk thistle extract, curcumin, n-acetylcystein, artichoke extract, vitamin D and Chromium picolinate compared to placebo on liver function in patients with non-alcoholic fatty liver (NAFLD)

66 participants (no=33 per group) are randomly assigned to intervention and placebo group using random digit table

This double blinded study will be performed in Fayaz Bakhsh Hospital. At base line and after 12 weeks of intervention with supplement/placebo, liver function tests (ALT, AST, ALK-Ph) , Fibrosis-4 (FIB-4), AST to Platelet Ratio Index (APRI) score and lipid profile (T.Chol, LDL-c, HDL-c, TG) will be recorded.

Inclusion criteria: Liver function enzymes higher than normal level, Fatty liver diagnosis based on sonography, Age>18 years Willing to participate in the study Exclusion criteria: having known kidney disease, having known heart disease, pregnancy or lactation

Patients will receive 1000 mg supplement capsule or placebo once daily for 12 weeks. Each capsule contains 175 mg milk thistle extract, 250 mg curcumin, 150 mg n-acetylcystein, 250 mg artichoke extract, 600 IU vitamin D, 100 mcg Chromium picolinate and 100 mg crumium picolinate and maltodextrine in placebo group.

Liver function tests (ALT, AST, ALK-Ph), Fibrosis-4 (FIB-4), AST to Platelet Ratio Index (APRI)

Block Randomization method is used to randomize the patients. For randomization, we will visit the www.sealedenvelope.com and use randomization tab to make a list considering the number of intervention groups, sample size, block size ( 4 is selected for current study). The prepared list that contains the pattern of patient allocation will be obtained and used. This site is designed in such a way that there is no limit on the number of groups for random allocation. According to the total number of samples required for the study, which is 80 patients (40 patients in the intervention group (A) and 40 patients in the control group (B)), 20 blocks with a volume of four includes two groups A and B will be randomly selected using the software, such as (ABAB) ، (BBAB)، (AABB)، (ABBA)، (BAAB ......( Then 80pockets (40 pockets containing paper containing A and 40 pockets containing B) will be prepared based on sample size. According to a list of blocks, a trained person outside of the research team will be set the row of pockets. After admission of each patient will be given a pocket and assigned to Group A (intervention) or B (control group), and the sample process will be performed sequentially until the end of completion of sample size.

It is a double blind study. A third person out of study team (clinic secretary) have the sequence of codes that provide the team with sealed pockets coded as A or B at the time of sampling. The following groups of people involved in the trial: participants, research team including principle investigator, data collectors, and outcome assessors will be blind. After analyzing the data investigators and outcome assessors will be unblinded about A and B group allocation to supplement and placebo. Patients in supplement and placebo groups will receive packages of similar capsules.

Coded data of the participants, study protocol, and report of the main output of the study would be available in case of researchers' reasonable request sending to principal investigator of the study 6 months after publishing the article.

starting 6 months after publication

University researchers

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Email to soodehrazeghi@gmail.com

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