Objective: This study attempted to investigate acute effect of strenuous physical activity with & without saffron supplementation on heat shock protein 70 (HSP70), interleukin-6 (IL-6) and TNFα in male mountain climbers.
Inclusion criteria : with minimum 2 years mountaineering ; Climbing experience at minimum height of 4000 meter ; A minimum height of 3500 m bivouac; who were not smoking; No overweight ;No history of endocrine diseases;No diabetes;No heart disease and chronic disease
exclusion criteria : Endocrine diseases ; Diabetes; Heart disease and any disease
lack of taking the supplements for any reason; Failure to observe the test conditions such as altitude sports .
Eleven male climbers with an age range of 27-37 years old ran at one session physical activity with intensity 80-90% of maximum heart rate for 45 minutes on a -5% slope surface. 3 days after recovery, the subjects were given 300 mg of dried stigmas of saffron in capsules once a day for ten days. Subsequently, the subjects again before, immediately and after one hour physical activity to measure HSP70, IL-6 and TNFα.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052622416N1
Registration date:2016-08-15, 1395/05/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-15, 1395/05/25
Registrant information
Name
Fatemeh Jan Bozorgi
Name of organization / entity
Islamic Azad University, Science and Research
Country
Iran (Islamic Republic of)
Phone
+98 21 6684 7082
Email address
fatemeh.janbozorgi@srbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
personal
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2015-12-06, 1394/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of one section strenuous physical activity & Crocus stavus Supplementation on HSP 70 , IL-6, TNF α in male mountain climbers
Public title
Effect of one section strenuous physical activity & Crocus stavus Supplementation on HSP 70 , IL-6, TNF α in male mountain climbers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : with minimum 2 years mountaineering ; Climbing experience at minimum height of 4000 meter ; A minimum height of 3500 m bivouac; who were not smoking; No overweight ;No history of endocrine diseases;No diabetes;No heart disease and chronic disease
exclusion criteria : Endocrine diseases ; Diabetes; Heart disease and any disease
lack of taking the supplements for any reason; Failure to observe the test conditions such as altitude sports
Age
From 27 years old to 37 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
11
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee Ethics in biomedical research Science and Research Branch of Islamic Azad University
Street address
Islamic Azad University, Science and Research, Boulevard of Martyrs HESARAK, University Square, the martyr Stari highway, Tehran
City
Tehran
Postal code
1477893855
Approval date
2016-06-19, 1395/03/30
Ethics committee reference number
IR.IAU.SRB.REC.1395.7
Health conditions studied
1
Description of health condition studied
Effect of one section strenuous physical activity & Crocus stavus Supplementation
ICD-10 code
Z00.6,Z00
ICD-10 code description
Examination for normal comparison and control in clinical research programme
Primary outcomes
1
Description
Hsp 70
Timepoint
Before Saffron supplementation: Before physical activity , Immediately after physical activity , 1 hour post-physical activity - After supplementation Saffron : Before physical activity , Immediately after physical activity , 1 hour after physical activity
Method of measurement
Using blood, serum Hsp70 value in Nanograms per deciliter by Kit
2
Description
IL-6
Timepoint
Before Saffron supplementation: Before physical activity , Immediately after physical activity , 1 hour post-physical activity - After supplementation Saffron : Before physical activity , Immediately after physical activity , 1 hour after physical activity
Method of measurement
Using blood, serum IL-6 value in Picograms per deciliter by Kit
3
Description
TNFα
Timepoint
Before Saffron supplementation: Before physical activity , Immediately after physical activity , 1 hour post-physical activity - After supplementation Saffron : Before physical activity , Immediately after physical activity , 1 hour after physical activity
Method of measurement
Using blood, serum TNFα value in Picograms per deciliter by Kit
Secondary outcomes
empty
Intervention groups
1
Description
Saffron supplementation; dose of 300 mg per day; once per day; for 10 days
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
IR Iran Mountaineering & Sport Climbing Federation
Full name of responsible person
Fatemeh Jan Bozorgi
Street address
The Parliament Issue 19, Iranian Revolutionary Guards, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Islamic Azad University, Science and Research
Full name of responsible person
Fatemeh Jan Bozorgi
Street address
Islamic Azad University, Science and Research, Boulevard of Martyrs HESARAK, University Square, the martyr Stari highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Islamic Azad University, Science and Research
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
Islamic Azad University, Science and Research
Full name of responsible person
Fatemeh Jan Bozorgi
Position
Sports Physiology graduate student
Other areas of specialty/work
Street address
Islamic Azad University, Science and Research, Boulevard of Martyrs HESARAK, University Square, the martyr Stari highway, Tehran
City
Tehran
Postal code
1477893855
Phone
+98 214486517982
Fax
Email
Fattima25jb@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Science and Research
Full name of responsible person
Farshad Gazalian
Position
PhD Sports Physiology
Other areas of specialty/work
Street address
Islamic Azad University, Science and Research, Boulevard of Martyrs HESARAK, University Square, the martyr Stari highway, Tehran
City
Tehran
Postal code
1477893855
Phone
+98 214486517982
Fax
Email
Phdghazalian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Science and Research
Full name of responsible person
Fatemeh Jan Bozorgi
Position
Sports Physiology graduate student
Other areas of specialty/work
Street address
Islamic Azad University, Science and Research, Boulevard of Martyrs HESARAK, University Square, the martyr Stari highway, Tehran
City
Tehran
Postal code
1477893855
Phone
+98 214486517982
Fax
Email
Fattima25jb@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)