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Effect of Beta-hydroxy beta-methylbutyrate, Arginine and Glutamine supplementation in patients undergoing cardiac surgery on postoperative outcomes

Protocol summary

Study aim
Compare the mean concentration of immune factors before and after surgery in the intervention and control groups (White Blood Cell, Red Blood Cell, lymphocytes, Neutrophils, Interleukin 6, Interleukin 1, Tumor necrosis factor α) Determine and comparing the mean concentration of inflammatory factors before and after surgery in the intervention and control groups (Erythrocyte sedimentation rat, High-sensitive CRP)
Design
A clinical trial with a control group, in parallel, will be perform on 80 patients
Settings and conduct
Patients will selected by randomized block sampling from Shahid Rajaei Heart Hospital in Tehran will be contacted before surgery until 30 days before surgery and receive sachets containing supplement and placebo. After confirmation, patients are asked to mix and consume 2 sachets containing supplement with beta hydroxy beta-methylbutyrate, arginine and glutamine or placebo with 120 cc of water daily.
Participants/Inclusion and exclusion criteria
Willingness to cooperate and complete the informed consent form by the patient؛ Age 18 to 70 years, Body mass index above 18.5 and below 30
Intervention groups
The intervention group will receive a dietary supplement containing Beta-hydroxy methylbutyrate,Glutamine and Arginine to evaluate its effect on the consequences after heart surgery, and the control group will use packages similar to the same dietary supplement containing maltodextrin.
Main outcome variables
The mean concentration of immune factors before and after surgery did not differ between the intervention and control groups. The mean concentration of inflammatory factors before and after surgery did not differ between the intervention and control groups. The mean concentration of muscle factors before and after surgery is not different between the intervention and control groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120913010826N31
Registration date: 2020-10-13, 1399/07/22
Registration timing: registered_while_recruiting

Last update: 2020-10-13, 1399/07/22
Update count: 0
Registration date
2020-10-13, 1399/07/22
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-26, 1399/05/05
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Beta-hydroxy beta-methylbutyrate, Arginine and Glutamine supplementation in patients undergoing cardiac surgery on postoperative outcomes
Public title
Effect of beta-hydroxy beta-methylbutyrate, arginine and glutamine on complication after cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate and complete the informed consent form by the patient Age 18 to 70 years Body mass index (BMI) above 18.5 and below 30 Do not take supplements or formulas to strengthen the immune system before starting the study No infection and sepsis No need for other entral formulas due to special problems (kidney, lung, liver, etc) Candidate patients for heart surgery
Exclusion criteria:
Drugs that affect metabolism such as steroids and male and female hormonal drugs or corticosteroids Abnormal liver function Metastatic cancer and autoimmune diseases Patients with thyroid, pituitary and hypothalamus dysfunction
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to the intervention or placebo, using a computer-generated sequence allocation with permuted blocks, in blocks of 2 with 1:1 allocation ratio to each group . Allocation concealment was via sealed opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study supplements were identical in appearance . Investigators, patients, and clinicians will be blinded to treatment assignment.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ٍEthics committee of shahid sadoughi medical science university
Street address
Shahid sadoughi, Yazd
City
Yazd
Province
Yazd
Postal code
2010102748
Approval date
2019-12-31, 1398/10/10
Ethics committee reference number
ir.ssu.sph.rec.1398.122

Health conditions studied

1

Description of health condition studied
cardiac surgery patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Biochemical evaluation of interleukin 1 (mean serum interleukin-1 concentration) Biochemical evaluation of interleukin 6 (mean serum interleukin-1 concentration) Biochemical evaluation of TNF-alpha (mean serum TNF-alpha concentration)
Timepoint
Before and after of surgery
Method of measurement
Biochemical experiments

Secondary outcomes

1

Description
Duration of hospitalization in ICU and hospital
Timepoint
After cardiac surgery
Method of measurement
Check the patient file

Intervention groups

1

Description
Intervention group: Intervention group will receive supplement which contains 7 grams of glutamine, 7 grams of arginine and 1.5 grams of hydroxy methylbutyrate. These supplements are given to patients twice a day for 1 month. Patients are given complete training before taking the supplement that mix sachets with 120 cc of cold water and consume.
Category
Treatment - Drugs

2

Description
Control group:Patients in the control group are given sachets containing maltodextrin, which are very similar to Hilagen supplements. These people are also told to consume 2 sachets daily with 120 cc of cold water.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Mona Norouzi
Street address
Vali-e-Asr St, Shahid Rajaee hospital
City
Tehran
Province
Tehran
Postal code
2010102748
Phone
+98 21 2392 2225
Email
mona.noruzi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Azadeh Nadjarzadeh
Street address
Shahid Sadoughi St.
City
Yazd
Province
Yazd
Postal code
20101012748
Phone
+98 35 3820 9131
Email
azadehnajarzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr Azadeh Nadjarzadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Sadoughi
City
Yazd
Province
Yazd
Postal code
2010102748
Phone
003538209131
Email
azadehnajarzadeh@gamil.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid sadoughi
City
Yazd
Province
Yazd
Postal code
20101012748
Phone
003538209131
Email
azadehnajarzadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Sadoughi University
City
Yazd
Province
Yazd
Postal code
2010102748
Phone
003538209131
Email
azadehnajarzadeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcomes and variables will be shared and personal information is confidential
When the data will become available and for how long
Access starts about 3 months after the results are published.
To whom data/document is available
Students and graduates of this field
Under which criteria data/document could be used
For use in similar research work
From where data/document is obtainable
Dr Azadeh Najarzadeh: azadehnajarzadeh@gmail.com Mona Norouzi : mona.noruzi@yahooo.com
What processes are involved for a request to access data/document
The file and data will be sent to you two weeks after the review.
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