Effects of 12 Weeks Resistance Training with Vitamin E Supplementation on Aminotransferase Enzymes, CTRP2/CTRP9, Insulin Resistance and Sensitivity, and Atherogenic Index of Plasma in Men with non-alcoholic fatty liver: A Double-blind, Randomized, Placebo-controlled Trial

Determining the effects of 12 Weeks Resistance Training with Vitamin E Supplementation on Aminotransferase Enzymes, CTRP2/CTRP9, Insulin Resistance, and Atherogenic Index of Plasma in Men with non-alcoholic fatty liver: A Double-blind, Randomized, Placebo-controlled Trial

A randomized, double-blind, placebo-controlled, phase 3 clinical trial was conducted on 40 patients with non-alcoholic fatty liver disease using factorial groups and simple individual randomization method with sealed envelopes.

The present study aimed to evaluate the effects of resistance training and vitamin E supplementation on patients with non-alcoholic fatty liver disease. A group of 40 subjects residing in Kermanshah city were randomly assigned to one of four groups and underwent a 12-week intervention involving exercise and either vitamin E supplements or a placebo. Body composition evaluations, ultrasound scans, and blood tests were conducted before and after the intervention. The researcher and subjects were blinded to the type of supplement administered.

- The absence of diabetes, cirrhosis, hepatitis, and prostate diseases - Not taking drugs that increase the levels of transaminases - Body mass index of 25 kg/m2 or more - Not consuming more than 30 g of alcohol per day for 3 consecutive months in the past 5 years - Not engaging in regular sports activities in the 6 months before the study - Diagnosis of fatty liver through ultrasound (at least first-degree steatosis)

Resistance training + vitamin E group; Resistance training + placebo group; Vitamin E group; Placebo group.

C1q/TNF-Related Protein-2; C1q/TNF-Related Protein-9; Insulin resistance and sensitivity index; Atherogenic index of plasma; AST enzyme; ALT enzyme.

For this study, a simple randomization method was employed as follows: -For a 40-patient trial, you will need 40 identical, opaque, letter-sized envelopes, 40 sheets of standard-size paper, and a Tupperware-style plastic container large enough to hold all 40 envelopes. -To start the experiment, we divided the 40 sheets of standard-size paper into 4 groups of 10. we then labeled each group with an intervention type as follows: Treatment 1 (exercise + A supplement), Treatment 2 (exercise + B supplement), Treatment 3 (A supplement), and Treatment 4 (B supplement). -We prepared envelopes for different types of treatments in the following way: Firstly, we wrote the type of treatment on each set of 10 papers. Then, we folded the papers and placed them inside the envelopes. Finally, we sealed the envelopes and kept each set's envelopes separately without writing anything on them. -To randomize the envelopes, they were shuffled thoroughly as if they were a deck of cards. Then, a unique number ranging from 1 to 40 was written on each envelope, respectively. After that, the envelopes were placed in a plastic container that resembled a Tupperware box. The subjects were assigned an envelope based on the numerical order, according to their recourse order. This determined the type of intervention they received.

The pharmaceutical company was requested to label the type of supplement as either A or B, without revealing which substance each letter represented until the end of the intervention period. This was considered during randomization and the sheets were labeled using the letters A and B instead of writing the type of supplement received (vitamin E or placebo) on them. For instance, the intervention group could be exercise + supplement A.

The personal information of the study participants can be shared once it has been de-identified. Any identifying information will be removed to protect personal privacy.

The access period begins six months after the results have been published.

This resource will only be accessible to researchers who are affiliated with academic and scientific institutions.

The use of data is permitted only for conducting similar scientific research and not for the personal gain of individuals or specific groups.

Full name: Irfan Varmazyar Way of communication: irfan26398@gmail.com

Sending the request to the mentioned email; Checking the person's request; Sending data within 5-7 days if they have convincing conditions.