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IRCT20200301046655N4 IRCT 2023-08-28 Tehran University of Medical Sciences Investigating the effect of beta-hydroxy beta-methylbutyrate in bariatric surgery Evaluation the effect of beta-hydroxy beta-methylbutyrate supplementation on the prevention of postoperative sarcopenia in patients undergoing bariatric surgery: a double-blind clinical trial study 2023-09-23 anticipated 80 Complete https://irct.ir/trial/72237 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this trial, the balanced random block method will be used, with a block size of 4 (combination of A and B as groups). Using the website Randomization.com, random allocation will be done for 80 people in the form of 20 blocks of 4. Since body mass index is an important variable in the intervention effect. This intervention will be implemented in a classified manner. In order to carry out this experiment correctly, a random allocation list will be produced separately for each of the two classes of body mass index 40 to 45 and 45 to 50, Blinding description: One of the nurses will be responsible for randomly selecting patients and prescribing supplements for them. In order to carry out this research blindly, the supplements will be completely similar and closed in terms of appearance. Also, HMB supplement and placebo are separated by a specific code from the company, which will be determined after analyzing the results of the code for each group. Researchers and doctors will not know about the studied groups and the type of supplement prescribed. 3 Mini bypass surgery. Intervention 1: Intervention group: They will receive beta-hydroxy beta-methylbutyrate (HMB) powder (Karen Company) at the rate of 3 grams per day for 30 days after surgery. Intervention 2: Control group: They will receive placebo with starch content (Karen company) for 30 days after surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Razieh Khalooeifard
Sina Hospital, Hassan Abad Square, Imam Khomeini St.
Tehran Iran (Islamic Republic of) 11367 46911 +98 21 6634 8500 shkhalooei1367@gmail.com Tehran University of Medical Sciences scientific Razieh Khalooeifard
Sina Hospital, Hassan Abad Square, Imam Khomeini St.
Tehran Iran (Islamic Republic of) 11367 46911 +98 21 6634 8500 shkhalooei1367@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Candidate for mini bypass surgery Body mass index 40 to 50 18 years 65 years Both Absence of severe hepatic impairment Absence of renal impairment Previous history of bariatric surgery Bariatric Z98.84 Prevention Prevention Intervention group: They will receive beta-hydroxy beta-methylbutyrate (HMB) powder (Karen Company) at the rate of 3 grams per day for 30 days after surgery. Control group: They will receive placebo with starch content (Karen company) for 30 days after surgery. Muscle mass. Timepoint: Before surgery, 1, 3 and 6 months after surgery. Method of measurement: Bioimpedance analyzer. Lean mass. Timepoint: Before surgery, 1, 3 and 6 months after surgery. Method of measurement: Bioimpedance analyzer. Tehran University of Medical Sciences Approved 2023-08-20 Research Ethics committee of Sina Hospital Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town Tehran Tehran Iran (Islamic Republic of)