Protocol summary

Study aim
Comparison of HMB Beta-Hydroxy beta-Methyl Butyrate Complementary Effects along with Selected Resistance Exercises on Liver, Muscle, Kidney Enzymes, Lipid Profile, Body Combination, and Some Other Physical Fitness Factors in Bodybuilding Athletes
Design
The sample size in this study was 40 people who were randomly divided into two experimental and control groups. After resistance training and HMB (by the experimental group) and polydextrose (by the control group), two samples were taken from all samples in the laboratory, and some biochemical factors in the serum of the subjects were analyzed.
Settings and conduct
The study site of Moradnia Club is in Lahijan. The experimental supplement group HMB and the placebo group received polydextrose capsules at a dose of 3 g / day as two succulents for 14 days. The subjects' training program included resistance exercises with a dual pyramid pattern for 8 weeks and 3 sessions per week. Laboratory and field tests are performed 48 hours before and after the training program.
Participants/Inclusion and exclusion criteria
inclusion criteria: age (19 to 23 years), gender (male) Exclusion criteria: 1) no history of cardiorespiratory, musculoskeletal, neurological, hormonal or orthopedic disorders, 2) no change in daily diet during the study, and 3) no ingestion of androgenic and energetic supplements in the past 1 months.
Intervention groups
Intervention groups consisted of two groups: a combined group (resistance training + HMB supplement) and a control group (resistance training + placebo).
Main outcome variables
Liver enzymes (ALT, AST), muscle (CPK, LDH), renal (BUN, UREA, Creatinine), lipid profile (cholesterol, LDL, HDL.TAG) and some physical fitness factors (strength, body composition, and Power)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180503039517N4
Registration date: 2020-07-14, 1399/04/24
Registration timing: retrospective

Last update: 2020-07-14, 1399/04/24
Update count: 0
Registration date
2020-07-14, 1399/04/24
Registrant information
Name
Soleyman Ansari Kolachahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2906
Email address
solomonansari@phd.iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of beta-hydroxy beta-methyl butyrate HMB supplementation with selected resistance training on some biochemical factors of blood and strength in bodybuilding athletes
Public title
The effects of beta-hydroxy beta-methyl butyrate HMB supplementation with selected resistance training on Liver, Muscular, Kidney Enzymes, Lipid Profile, Body Combination, Strength and Some Other Physical Fitness Factors in Bodybuilding Athletes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age (19-29years) Gender (male) a maximum of 3 months involving in resistance exercise
Exclusion criteria:
smoking having cardiorespiratory, musculoskeletal, neurological, hormonal or orthopedic disorders No ingestion of androgenic and energetic supplements in the past 1 months
Age
From 19 years old to 29 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 63
Randomization (investigator's opinion)
Randomized
Randomization description
40 bodybuilders were selected by available sampling method. Through drawing (The participants' names were written on paper and selected through a simple random draw for the two intervention groups and a control group).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, participants are unaware of the group assigned to themselves and other participants. A separate workout hour is considered for each intervention group. The person in charge of collecting data and the processor are also unaware of the type of intervention and the people involved in the research groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Islamic Azad University, Rasht Branch
Street address
Islamic Azad University, Rasht Branch, Lakan Blv
City
RASHT
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
IR.IAU.RASHT.REC.1399.016

Health conditions studied

1

Description of health condition studied
supplementation in body builders
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum levels of liver enzymes (Aspartate transaminase (AST) and Alanine transaminase (ALT)
Timepoint
Initial blood sampling will be performed in the pre-test phase two days before the start of the study, and final blood sampling will be performed in the post-test phase two days after the end of the study in the laboratory.
Method of measurement
Using the Pars Azmoun laboratory kit (made in Iran) according to the manufacturer's instructions and the ELISA method.

2

Description
Serum levels of muscle enzymes (Creatine kinase (CK) and lactate dehydrogenase (LDH))
Timepoint
Initial blood sampling will be performed in the pre-test phase two days before the start of the study, and final blood sampling will be performed in the post-test phase two days after the end of the study in the laboratory.
Method of measurement
Using Pars Azmoun laboratory kit (made in Iran) according to the manufacturer's instructions and the ELISA method.

3

Description
Serum levels of renal function enzymes (the blood urea nitrogen (BUN), Creatinine and Urea
Timepoint
Initial blood sampling will be performed in the pre-test phase two days before the start of the study, and final blood sampling will be performed in the post-test phase two days after the end of the study in the laboratory.
Method of measurement
Using the Pars Azmoun laboratory kit (made in Iran) according to the manufacturer's instructions and the ELISA method.

4

Description
Serum levels of Lipid profile (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, Total cholesterol and triglycerides
Timepoint
Initial blood sampling will be performed in the pre-test phase two days before the start of the study, and final blood sampling will be performed in the post-test phase two days after the end of the study in the laboratory.
Method of measurement
Using Biosystems Laboratory kit (made in Spain), according to the manufacturer's instructions and the ELISA method.

5

Description
Some physical fitness factors (strength, body composition and power)
Timepoint
Initial measurements in the pre-test phase will be performed two days before the start of the study, and final measurement in the post-test phase will be performed two days after the end of the study at the club.
Method of measurement
One maximum repetition test and body mass index (BMI) will be used to measure strength and body composition.

Secondary outcomes

empty

Intervention groups

1

Description
The experimental group performed selected resistance exercises for 8 weeks and 3 sessions per week and received HMB supplement in the amount of 3 g per day as two suckers for 14 days. Blood samples are taken from all samples in the laboratory before and after exercise (48 hours apart) and some biochemical factors such as liver, muscle, kidney, and lipid profiles are analyzed in the serum of the subjects. Placed.
Category
Other

2

Description
Control group: The selected resistance exercises were performed for 8 weeks and 3 sessions per week and the polydextrose capsule was taken in the amount of 3 g per day as two suckers for 14 days. Blood samples are taken from all samples in the laboratory before and after exercise (48 hours apart) and some biochemical factors such as liver, muscle, kidney, and lipid profiles are analyzed in the serum of the subjects.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Moradnia Sports Club
Full name of responsible person
Mohammad Moradnia
Street address
Afrooz Alley, 7th Alley, Jomhuri Eslami Street, Lahijan, Guilan
City
RASHT
Province
Guilan
Postal code
4419865615
Phone
+98 13 3375 2906
Email
solomonansari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Seidavi
Street address
Islamic Azad University of Rasht Branch, Lakan Blv
City
RASHT
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13 3342 2153
Email
solomonansari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University of Rasht Branch
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
Islamic Azad University
Full name of responsible person
Soleyman Ansari Kolachahi
Position
Non faculty doctor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
second floor, Adibsaber Apartment, next to Esparo restaurant, Prof. Samei Blv.
City
RASHT
Province
Guilan
Postal code
4193193933
Phone
+98 911 230 6198
Email
solomonansari@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soleyman Ansari Kolachahi
Position
Non faculty specialist
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
second floor, Adibsaber Apartment, next to Esparo restaurant, Prof. Samei Blv.
City
RASHT
Province
Guilan
Postal code
4193193933
Phone
+98 911 230 6198
Email
solomonansari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soleyman Ansari Kolachahi
Position
Non faculty specialist
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
2nd floor, Adibsaber Apartment,next to Esparo restauant, Prof. Samei Blv.
City
RASHT
Province
Guilan
Postal code
4193193933
Phone
+98 911 230 6198
Email
solomonansari@yahoo.com

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
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Raw and processed data
When the data will become available and for how long
Start of access period from 1400
To whom data/document is available
Academic researchers, research colleagues and participants
Under which criteria data/document could be used
Use research results and data in future meta-analysis research
From where data/document is obtainable
Corresponding Author
What processes are involved for a request to access data/document
Request the researcher via email
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