The effects of curcumin supplementation on inflammatory markers , oxidative stress , muscle damage and anthropometric markers in female athletes
Design
In this study 80 eligible girls are selected. The participants were randomly divided into two groups of control and intervention. Group allocation was concealed by assignong a unique code to each participants.
Settings and conduct
The present study is a double-blind randomized clinical trial study. Participants and researcher will not be aware of the type of intervention they have been assigned. The target population includes female athletes in the city of Isfahan. The number of participants in this study is 80, the subjects will be divided into two groups and 40 will be in each group. Patients in the intervention and control group receive 500 mg of curcumin or placebo for 8 weeks each day. Participants and researcher will not be aware of assigned interventions.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Willingness to participate in the study
2. Female sex
3. Not using antioxidant supplements and anti-inflammatory drugs
4. History of at least 3 years of continuous exercise
5. Age between 20-30
Exclusion criteria:
1. Following less than 70%
2. Unwillingness to continue
3. Afflicated by a special diseases throught the study
4. smoking
Intervention groups
Persons in the intervention group will receive curcumin (500 mg curcumin from Karen Company) for 8 weeks.
Persons in the control group will take placebo (500 mg of corn starch) for 8 weeks.
Main outcome variables
C-reactive protein (CRP) ; malondialdehyde ; lactate dehydrogenase
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N33
Registration date:2018-04-04, 1397/01/15
Registration timing:retrospective
Last update:2018-04-04, 1397/01/15
Update count:0
Registration date
2018-04-04, 1397/01/15
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of curcumin supplementation on inflammatory markers , oxidative stress , muscle damage and anthropometric markers in female athletes
Public title
The effect of curcumin supplementation on athletes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
willingness to participate in the study
Female athletes of Isfahan
Not using antioxidant supplements and anti-inflammatory drugs
History of at least 3 years of continuous exercise
Age between 20-30
Exclusion criteria:
following less than 70% , loss to follow up
unwillingness to continue, loss to follow up
Afflicated by a special diseases
smoking
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method was used, randomization unit was used individually and we used statistical software. We assigned each participant to study a code and entered the code into SPSS software. The software selected a random number.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to eliminate the error from the patient's and researcher's awareness of the type of treatment received and its possible effect on the outcome of the study, we will conduct a double-blind study. Due to the fact that placebo and supplementation of curcumin are completely in the capsule, the participants and the researcher are not aware of the type of supplement they received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8135798111
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR.MUI.REC.1396.2.045
Health conditions studied
1
Description of health condition studied
athlete
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
C-reactive protein (CRP)
Timepoint
The beginning (before intervention) and the end of the study (60 days after intervention)
Method of measurement
blood sample
2
Description
Total antioxidant capacity
Timepoint
The beginning (before intervention) and the end of the study (60 days after intervention)
Method of measurement
blood sample
3
Description
malondialdehyde
Timepoint
The beginning (before intervention) and the end of the study (60 days after intervention)
Method of measurement
blood sample
4
Description
lactate dehydrogenase
Timepoint
The beginning (before intervention) and the end of the study (60 days after intervention)
Method of measurement
blood sample
Secondary outcomes
1
Description
maximum rate of oxygen consumption (vo2max)
Timepoint
The beginning (before intervention) and the end of the study (60 days after intervention)
Method of measurement
step test
2
Description
body composition
Timepoint
The beginning (before intervention) and the end of the study (60 days after intervention)
Method of measurement
Bioimpedance system
Intervention groups
1
Description
Intervention group: curcumin, 500 mg capsule, once per day, for 8 weeks
Category
Treatment - Drugs
2
Description
control group: placebo of curcumin containing corn starch, 500 mg capsule, once per day, for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
city of isfahan
Full name of responsible person
Dr.Gholamreza Askari, MD, PhD of Nutrition sciences, Assistant Professor
Street address
Street address Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Amir mansour alavi
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3175
Email
am.alavi@nutr.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
mina salehi
Position
Master student of nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezar Jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3171
Fax
Email
mina_salehi1371@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Askari
Position
MD, PhD of Nutrition sciences, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezar Jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3171
Fax
Email
askari@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
mina salehi
Position
master student of nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezar Jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3171
Fax
Email
mina_salehi1371@yahoo.com
Web page address
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