Effect of high protein supplementation on inflammatory indices and muscle damage on basketball athletes
Design
This randomized double-blind controlled clinical trial with parallel groups will be conducted on 44 healthy young men who will be randomly categorized into control and intervention groups.
Settings and conduct
This study will be conducted during 8 weeks on 44 basketball men who are members of clubs approved by the basketball board of Kermanshah province. After explaining the purpose of the study and obtaining informed consent, the participants will be evaluated in term of anthropometric indices, nutritional status, inflammatory indices and painful muscle index.
For evaluation of blood inflammatory indices, 10 cc fasting blood samples will be obtained.
Then the participants will be classified into control and intervention groups in which the researcher and the participants will not be aware of the groups allocation. The control group will receive 25 grams daily of Whey protein supplement and the control group will receive the same amount of placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Participants should be male;
New member of basketball team;
Age range between 20-30 year;
Body mass index (BMI) between 20-25 kg/m2;
Voluntary participation.
Exclusion criteria:
Having systemic diseases or having a history of trauma;
Under the diet and special diet plan, up to 6 months before the study;
Use of any dietary supplement and exercise up to 6 months before the study;
Intervention groups
The first group will receive 25 grams of Whey protein supplement ( 3 doses of 8.3 g at 10 A.M, 1 P.M and 4 P.M) daily and the second group will receive placebo (25 g of starch at the same time and the same amount).
Main outcome variables
Blood inflammatory index; Painful muscle index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181111041611N1
Registration date:2019-03-09, 1397/12/18
Registration timing:retrospective
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Mehnoosh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3710 2009
Email address
mehnoosh_samadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of high protein supplementation on inflammatory indicators and muscle damage on basketball athletes in Kermanshah
Public title
Effect of high protein supplementation on inflammatory indicators and muscle damage on basketball athletes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Participants should be male
New member of basketball team
Age range between 20-30 year
Body mass index (BMI) range between 20-25 kg/m2
Voluntary participation
Exclusion criteria:
Having systemic diseases or having a history of trauma
Under the diet and special diet plan, up to 6 months before the study
Use of any dietary supplement and exercise up to 6 months before the study
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Using the draw method:
The names of the participants will be written on the separate papers and will be placed inside a container. Then the names of the participants will be withdrawn randomly and will be placed in the intervention or control groups. The first 20 names will be placed in the intervention group and the rest in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researchers and participants will not be aware of the allocation of groups, and the supplements appearance will be similar in both groups. The supplemented manufacturer will encoded the supplements before delivery.
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
Building No. 2, Research Council of Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran.
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Approval date
2018-10-14, 1397/07/22
Ethics committee reference number
IR.KUMS.REC.1397.561
Health conditions studied
1
Description of health condition studied
Inflammatory indices
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Musculoskeletal Indicator
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of subjects with low inflammation index
Timepoint
Before the intervention and 8 weeks after starting to consume high protein supplement
Method of measurement
Measurement of inflammatory indices and painful muscular questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the intervention will be conducted with 25 grams of Whey protein supplement (Karenpharma co, Canada, Representation in Iran) 90% (in 3 doses of 8.3 gr at 10 am, 1 noon and 4 am) daily.
Category
Prevention
2
Description
Control group: With 25 g of starch (placebo) (in 3 doses of 8.3 g at 10 am, 13 noon and 16 am), it will be done daily.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Clubs approved by the basketball board of Kermanshah province
Full name of responsible person
Karam Ahmadian
Street address
Gomrek Street, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714897767
Phone
+98 83 3823 0218
Email
shimamoradi21@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Building No. 2, Research Council Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3837 6892
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences,Above Farabi Hospital,Iesar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3710 2009
Email
mehnoosh_samadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohamad Hozoori
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qom University of Medical Sciences,Shahid Lavasani Street
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2028
Email
mhozoori@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohamad Moradi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 5, Alley 143, Markazy
City
Kermanshah
Province
Kermanshah
Postal code
67146-97767
Phone
+98 838358058
Email
moradi1991@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
Trail that began to fall ill on 11th of January 1397 should have a release plan when recording its study protocol.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available