Protocol summary

Summary
Aim of this research is investigation of the effect of acute dark chocolate supplementation pre intensive exercise on Total Antioxidant Capacity, MDA, H2O2, uric acid and bilirubin in athlete’s girls. In this study, 16 subjects were selected from among volunteers who have at least 2 years of regular exercise, lack chronic disease and food allergies. After informed consent, subjects were divided into two experimental (dark chocolate consumption) and control (no consumption of dark chocolate) groups. The experimental group consumed dark chocolate for 3 days (80 mg per day), and a control group not consumed any supplement. After three days, both groups participated in the intensive exercise. Venous blood samples were taken in the three steps which include before intensive exercise, immediately after exercise and one hour after exercise for the measurement of MDA, H2O2, TAC, bilirubin and uric acid.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015031521481N1
Registration date: 2015-04-25, 1394/02/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-04-25, 1394/02/05
Registrant information
Name
Behrouz Baghaiee
Name of organization / entity
Mohaghegh Ardabili University
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2081
Email address
behrouz_phsport@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Alzahra University
Expected recruitment start date
2014-10-13, 1393/07/21
Expected recruitment end date
2014-11-06, 1393/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Short –Term Dark Chocolate Supplementation on Total Antioxidant Capacity, Malondialdehyde , Hydrogen Peroxide, Uric Acid and Bilirubin fallowing to intensive exercise.
Public title
Effect of Dark Chocolate Supplementation on Antioxidant in Athletes Girls
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having at least 2 years participating in regular exercises, being female, not having chronic diseases and food allergies Exclusion criteria: Having menstruation
Age
From 22 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Alzahra University
Street address
Alzahra University, Vanak Street, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-10-12, 1393/07/20
Ethics committee reference number
93.7.205

Health conditions studied

1

Description of health condition studied
immunological
ICD-10 code
R76
ICD-10 code description
Other abnormal immunological findings in serum

Primary outcomes

1

Description
Uric Acid
Timepoint
pre exercise, immediately after exercise, 1 h after exercise
Method of measurement
autoanalyzer

2

Description
Bilirubin
Timepoint
pre exercise, immediately after exercise, 1 h after exercise
Method of measurement
autoanalyzer

3

Description
Hydrogen Peroxide
Timepoint
pre exercise, immediately after exercise, 1 h after exercise
Method of measurement
autoanalyzer

4

Description
Total Antioxidant Capacity
Timepoint
pre exercise, immediately after exercise, 1 h after exercise
Method of measurement
autoanalyzer

5

Description
Malondialdehyde
Timepoint
pre exercise, immediately after exercise, 1 h after exercise
Method of measurement
autoanalyzer

Secondary outcomes

empty

Intervention groups

1

Description
The experimental group consumed three days (daily 80 grams) dark chocolate. After three days (before exercise), blood samples were taken. Then participated in the intensive exercise.venous blood samples were taken immediately and 1 h after exercise.
Category
Prevention

2

Description
The control group did not consumption supplements. blood samples were taken before exercise. Then participated in the intensive exercise.venous blood samples were taken immediately and 1 h after exercise.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra University
Full name of responsible person
Nasibeh Dowlat Abadi Farahani
Street address
Alzahra University, Vanak Street, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sciences Vice Chancellor for Research of Alzahra University
Full name of responsible person
Dr Ensieh Zahedi
Street address
Alzahra University,Vanak Street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sciences Vice Chancellor for Research of Alzahra University
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
Phd Student
Full name of responsible person
Behrouz Baghaiee
Position
Mohaghegh Ardabili University, University Street, Ardabil, Iran
Other areas of specialty/work
Street address
Ardabil
City
Ardabil
Postal code
Phone
+98 45 3351 2081
Fax
Email
behrouz_phsport@uma.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alzahra University
Full name of responsible person
Nasibeh Dowlat Abadi Farahani
Position
M.Sc
Other areas of specialty/work
Street address
Alzahra University, Vanak Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8804 4040
Fax
Email
nasibeh_6@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Behrouz Baghaiee
Position
Phd Student
Other areas of specialty/work
Street address
Mohaghegh Ardabili University, University Street, Ardabil, Iran
City
ardabil
Postal code
Phone
+98 45 3351 2081
Fax
Email
behrouz_phsport@uma.ac.ir
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
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