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
Determining the effect of beta-hydroxy beta-methylbutyrate supplementation on the prevention of postoperative sarcopenia in patients undergoing bariatric surgery.
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized, on 80 patients, with a convenient sampling method, and a table of numbers will be used for randomization.
Settings and conduct
This study will be conducted in patients who are candidates for elective mini-bypass surgery, among patients referred to bariatric surgery clinic in Sina Hospital, Tehran. One of the nurses will be responsible for randomly assigning 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.
Participants/Inclusion and exclusion criteria
Entry criteria: 1. Age 18 to 65 years 2. Body mass index 40 to 50 3. Candidate for elective mini-bypass surgery. Exclusion criteria: 1. Severe liver disorder 2. Kidney disorder 3. History of previous bariatric surgery
Intervention groups
People in the intervention group will receive HMB powder in the form of 3 grams per day, and people in the control group will receive a placebo with starch content for 30 days after surgery.
Main outcome variables
The amount of muscle mass, the amount of lean mass
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200301046655N4
Registration date:2023-08-28, 1402/06/06
Registration timing:prospective
Last update:2023-08-28, 1402/06/06
Update count:0
Registration date
2023-08-28, 1402/06/06
Registrant information
Name
Razieh Khalooeifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
shkhalooei1367@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigating the effect of beta-hydroxy beta-methylbutyrate in bariatric surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for mini bypass surgery
Body mass index 40 to 50
Exclusion criteria:
Absence of severe hepatic impairment
Absence of renal impairment
Previous history of bariatric surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Sina Hospital
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2023-08-20, 1402/05/29
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1402.065
Health conditions studied
1
Description of health condition studied
Mini bypass surgery
ICD-10 code
Bariatric
ICD-10 code description
Z98.84
Primary outcomes
1
Description
muscle mass
Timepoint
Before surgery, 1, 3 and 6 months after surgery
Method of measurement
Bioimpedance analyzer
2
Description
Lean mass
Timepoint
Before surgery, 1, 3 and 6 months after surgery
Method of measurement
Bioimpedance analyzer
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Prevention
2
Description
Control group: They will receive placebo with starch content (Karen company) for 30 days after surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Razieh Khalooeifard
Street address
Imam Khomeini St, Hassan Abad Square
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6634 8500
Fax
+98 21 6634 8587
Email
hosp_sina@sina.tums.ac.ir
Web page address
https://sinahospital.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Keshavarz Blvd., Qods Corner, Tehran University of Medical Sciences Headquarters
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Web page address
https://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razieh Khalooeifard
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini St.
City
Tehran
Province
Tehran
Postal code
11367 46911
Phone
+98 21 6634 8500
Email
shkhalooei1367@gmail.com
Web page address
https://sinahospital.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razieh Khalooeifard
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini St.
City
Tehran
Province
Tehran
Postal code
11367 46911
Phone
+98 21 6634 8500
Email
shkhalooei1367@gmail.com
Web page address
https://sinahospital.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razieh Khalooeifard
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
11367 46911
Phone
+98 21 6634 8500
Email
shkhalooei1367@gmail.com
Web page address
https://sinahospital.tums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available