Protocol summary

Summary
This study is designed to evaluate the effects of ginger and cinnamon consumption on body composition, exercise performance, muscle soreness, serum level of IL6 and MDA in female martial athletes in Isfahan clubs. We will conduct a randomized double blind placebo-controlled clinical trial involving sixty apparently healthy, well-trained female martial athletes (aged 13-25 yr) who exercised at least three times a week for 3 years. Participants will consume either 3 grams of ginger, cinnamon or placebo powder per day with daily drinks, depending on their groups for 6 weeks. Participants will be asked to record food intake in every 2 weeks of the trial for four times. Body composition, exercise performance, muscle soreness, inflammation and oxidative stress indexes and serum level of IL-6 and MDA will be determined in the beginning and at the end of the study and will be compared among ginger, cinnamon and placebo groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111095062N3
Registration date: 2012-12-03, 1391/09/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-03, 1391/09/13
Registrant information
Name
Reza Ghiasvand
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2742
Email address
ghiasvand@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2011-11-20, 1390/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Ginger and Cinnamon consumption on body composition, exercise performance and biochemical inflammatory indexes in female martial athletes in Isfahan clubs
Public title
The effects of Ginger and Cinnamon consumption on athletes
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria: Willingness to participate in study; exercise at least 3 years experience and a maximum of 5 years; ages 13 to 20 years; non smokers and drug non consumers; not consumption of supplements; Lack of specific diseases; not being in pregnancy and lactation. Exclusion criteria: allergic reaction to supplements; participants tend to leave the study at any stage of the study.
Age
From 13 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan Regional Bioethics committee
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Postal code
81745319
Approval date
2011-08-20, 1390/05/29
Ethics committee reference number
190022

Health conditions studied

1

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

Primary outcomes

1

Description
IL-6
Timepoint
before and after intervention
Method of measurement
blood biochemistr labratory tests

2

Description
MDA
Timepoint
before and after intervention
Method of measurement
spectrophotometery

3

Description
exercise performance
Timepoint
before and after intervention
Method of measurement
Based on distance traveled to reach the fatigue

4

Description
muscle soreness
Timepoint
before and after intervention
Method of measurement
According to participants

5

Description
body fat percentage
Timepoint
before and after intervention
Method of measurement
BIA machine

6

Description
weight
Timepoint
before and after intervention
Method of measurement
mechanical scale

7

Description
length
Timepoint
before and after intervention
Method of measurement
tape

Secondary outcomes

empty

Intervention groups

1

Description
The cinnamon group receives 3 grams of cinnamon powder solved in their sport drink for 6 weeks.
Category
Other

2

Description
The ginger group receives 3 grams of ginger powder solved in their sport drink for 6 weeks.
Category
Other

3

Description
The control group receives 3 grams of placebo powder(lactose) solved in their sport drink for 6 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Food Security Research Center, Department of Community Nutrition, School of Nutrition and Food Scien
Full name of responsible person
Reza Ghiasvand
Street address
Department of Community Nutrition, Department of Nutrition and Food Science, Isfahan University of Medical Sciences, Hezar Jerib St, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Isfahan University of Medical Sciences
Full name of responsible person
Doctor Peyman Adibi
Street address
School of Nutrition and Food sciences, Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of 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
Nafiseh Shokri
Position
MSc of nutrition
Other areas of specialty/work
Street address
School of Nutrition and Food sciences, Isfahan University of Medical Sciences, Hezarjarib St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2742
Fax
Email
nafiseh.shokri@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Reza Ghiasvand
Position
Ph.D. in Nutritional Sciences
Other areas of specialty/work
Street address
School of Nutrition and Food sciences, Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2742
Fax
Email
ghiasvand@hlth.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
Nafiseh Shokri
Position
MSc of nutrition
Other areas of specialty/work
Street address
School of Nutrition and Food sciences, Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Postal code
Phone
+31 17922742
Fax
Email
nafiseh.shokri@yahoo.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
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