Protocol summary

Summary
This double-blind clinical trial was designed to evaluate the effects of anthocyanin supplementation on inflammatory bio markers, exercise performance, muscle damage and body composition in male and female athletes in Isfahan University of Medical Science. In this evaluation fifty four healthy, non-professional athletes who exercised at least for 3 years and didn’t use antioxidant supplement in the past month were enrolled. Participants consumed either 100cc of anthocyanosid supplement or placebo for six weeks. C-reactive protein as inflammatory factor, lactate dehydrogenase, creatin kinas, body composition, heart rate, blood pressure and maximum oxygen consumption (Vo2max) were measured before and after intervention. Participants were asked to complete food frequency questionnaire for 1 day before intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013041311763N6
Registration date: 2013-06-06, 1392/03/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-06, 1392/03/16
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 Science
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2013-02-01, 1391/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Anthocyanin supplementation on, performance, inflammatory markers , muscle damage indices and body composition in athletes
Public title
Effect of anthocyanin supplementation on athletes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: don't Use of antioxidant supplements in the past month , At least 3 years experience performing continuous exercise, Willingness to participate in the study. Exclusion criteria: less than 70% adherence, tend to leave study, had disease that require special treatment.
Age
From 19 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan Univesity of Medical Sciences
Street address
Isfahan Univesity of Medical Sciences, Hezarjirib street
City
Isfahan
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
392156

Health conditions studied

1

Description of health condition studied
Sports Nutrition
ICD-10 code
Z00.8
ICD-10 code description
Other general examination

Primary outcomes

1

Description
time to exhustion
Timepoint
before intervention and after 6 week intervention
Method of measurement
treadmill

2

Description
plasma CRP
Timepoint
before intervention and after 6 week intervention
Method of measurement
blood test

3

Description
plasma LDH
Timepoint
before intervention and after 6 week intervention
Method of measurement
blood test

4

Description
plasma CK
Timepoint
before intervention and after 6 week intervention
Method of measurement
blood test

5

Description
Body composition
Timepoint
before intervention and after 6 week intervention
Method of measurement
body analyser

6

Description
vo2max
Timepoint
before intervention and after 6 week intervention
Method of measurement
treadmill

Secondary outcomes

1

Description
blood presure
Timepoint
before exercise test and after that ( berore and after intervention)
Method of measurement
presure indicator

2

Description
pulse rate
Timepoint
before exercise test and after that ( berore and after intervention)
Method of measurement
Neck pulse

Intervention groups

1

Description
Case group received 100 milligram anthocyanoside tablet per day for six weeks
Category
Prevention

2

Description
Control group received 100 milligram placebo per day for six weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Movahedian stadium
Full name of responsible person
Gholamreza Askari
Street address
Isfahan Univesity of Medical Sciences, Hezarjirib street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Doctor Peyman Adibi
Street address
Isfahan University of Medical Sciences
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Masume yarahmadi
Position
MSc of Nutrition
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2658
Fax
Email
myarahmadi466@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askar
Position
Ph.D of nutrition, Assistant Professor
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2110
Fax
Email
Askari@mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
masume yarahmadi
Position
Ph.D of nutrition, Assistant Professor
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2658
Fax
Email
myarahmadi466@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...