The effect of 8 weeks of milk protein concentrate supplementation on the level of blood lactate ،creatine kinase ،lactate dehydrogenase ،c-reactive protein in CrossFit men
Determining the effect of 8 weeks of milk protein concentrate supplementation on blood lactate, creatine kinase, lactate dehydrogenase and C-reactive protein levels in CrossFit men.
Design
A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 100 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Both groups will do crossfit exercises for 8 weeks and 4 sessions every week. Both groups will take 40 grams of the prescribed supplement and placebo one hour before going to sleep every night for 8 weeks. Exercises will be done in the Crossfit gym in Qasr Shirin city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at least 18 years old; Maximum 35 years; Having at least 6 months of training experience in CrossFit
Exclusion criteria: no injuries, no smoking and alcohol consumption; Not taking medical drugs or any sports supplements
Intervention groups
Using the table of random numbers, the subjects were divided into two groups: supplement with exercise and placebo with exercise. The supplement group with training consumed milk protein concentrate and the placebo group consumed maltodextrin with training.
Main outcome variables
Blood lactate, lactate dehydrogenase, creatine kinase, reactive protein c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231228060556N1
Registration date:2024-02-14, 1402/11/25
Registration timing:registered_while_recruiting
Last update:2024-02-14, 1402/11/25
Update count:0
Registration date
2024-02-14, 1402/11/25
Registrant information
Name
Sajad Yavari
Name of organization / entity
The University of Razi
Country
Iran (Islamic Republic of)
Phone
+98 83 4242 5563
Email address
syavari698@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2025-03-10, 1403/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of milk protein concentrate supplementation on the level of blood lactate ،creatine kinase ،lactate dehydrogenase ،c-reactive protein in CrossFit men
Public title
Investigating the effect of milk protein concentrate supplementation on CrossFit athletes.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 20 to 35 years
Having at least 6 months of CrossFit training experience
Exclusion criteria:
Having an injury
Taking any medical drugs or nutritional or sports supplements
Using tobacco or alcohol or psychotropic drugs
Age
From 20 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Tables of Random numbers are prepared by computers that arrange numbers randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research work, a person outside the research work was requested to help us as a helper in determining the supplement and placebo group. Then he determined the desired groups using a table of random numbers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
No. 4, Farvardin 3 Ave., Perozzi Street
City
Qhaser-shirin
Province
Kermanshah
Postal code
6781733931
Approval date
2023-11-29, 1402/09/08
Ethics committee reference number
IR.RAZI.REC.1402.089
Health conditions studied
1
Description of health condition studied
The effect of milk protein concentrate on inflammatory factors in CrossFit athletes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood lactate
Timepoint
Before starting and after the end of 8 weeks
Method of measurement
By Blood measurements
2
Description
Lactate dehydrogenase
Timepoint
Before starting and after the end of 8 weeks
Method of measurement
By Blood measurements
3
Description
Reactive Protein C
Timepoint
Before starting and after the end of 8 weeks
Method of measurement
By Blood measurements
4
Description
Creatine Kinase
Timepoint
Before starting and after the end of 8 weeks
Method of measurement
By Blood measurements
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group consists of 12 CrossFit athletes who receive 40 grams of milk protein concentrate daily one hour before bed for 8 weeks and do CrossFit training 4 times a week.
Category
Other
2
Description
Control group: The control group consists of 12 CrossFit athletes who receive 40 grams of maltodextrin placebo one hour before bed for 8 weeks and do CrossFit training 4 times a week.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Persian experimenters
Full name of responsible person
Sajad Yavari
Street address
Parsian Laboratory, Corner of Sixth Alley, Mustafa Emami Blvd, Kermanshah city
City
Kermansha
Province
Kermanshah
Postal code
67146-35585
Phone
+98 83 3822 8075
Email
syavari698@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
razi university
Full name of responsible person
mostafa mostafaee
Street address
kermanshah-razi-university
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3428 3272
Email
mo.azizi@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
razi university
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
The University of Razi
Full name of responsible person
Sajad Yavari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 4, Farvardin 3 Alley., Perozzi Street
City
Qhaser-shirin
Province
Kermanshah
Postal code
6781733931
Phone
+98 83 4242 5563
Email
syavari698@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Razi
Full name of responsible person
Sajad Yavari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No 4, Farvardin 3 Alley., Perozzi Street
City
Qhaser-shirin
Province
Kermanshah
Postal code
6781733931
Phone
+98 83 4242 5563
Email
syavari698@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Razi
Full name of responsible person
Sajad Yavari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No 4, Farvardin 3 Alley., Perozzi Street
City
Qhaser-shirin
Province
Kermanshah
Postal code
6781733931
Phone
+98 83 4242 5563
Email
syavari698@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available