The effect of different doses of garlic supplementation on coagulation factors and blood pressure after an acute endurance exercise in young active men
The effect of using of different doses of garlic supplementation on coagulation factors and blood pressure after an acute endurance exercise in young active men
Design
Clinical trial including three intervention groups of garlic supplement with three doses of 500, 750 and 1000 mg and acute endurance training and one placebo group
Settings and conduct
Fifteen healthy endurance runner young men from Tabriz sport clubs (age27.0±7.9years; weight73.9±6.4kg, height175.3±4.33cm) voluntarily participated in study. During 4 sessions, subjects took different garlic doses (500.750 and 1000mg) and placebo in separate days. In each session, four-hour after taking the supplement or placebo, subjects performed 30min of running on treadmill with 65-85% of target heart rate. Blood samples were taken before supplementation and placebo, before and immediately after exercise.
There is no blinding
Participants/Inclusion and exclusion criteria
Entrance and exit criteria include be health, non-smoking, no history of cardiovascular disease, hypertension, lower inferiority, sleep disorders, Do not use drug, supplements and caffeine at least 48 hours before the tests.
Intervention groups
500 mg garlic supplement and an acute endurance exercise
750 mg garlic supplement and an acute endurance exercise
1000 mg garlic supplement and an acute endurance exercise
Main outcome variables
Factor VIII
Fibrinogen
Phromboplastin time
Prothrombin time
Systolic and diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181114041655N4
Registration date:2019-08-16, 1398/05/25
Registration timing:retrospective
Last update:2019-08-16, 1398/05/25
Update count:0
Registration date
2019-08-16, 1398/05/25
Registrant information
Name
Ameneh Pourrahim Ghouroghchi
Name of organization / entity
Mohaghegh-e-Ardabili University
Country
Iran (Islamic Republic of)
Phone
+98 45 3150 5647
Email address
a.pourrahim@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of different doses of garlic supplementation on coagulation factors and blood pressure after an acute endurance exercise in young active men
Public title
The effect of doses of garlic supplementation on coagulation and blood pressure after an acute endurance exercise in young active men
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Health
Being active
Exclusion criteria:
Smoking
History of cardiovascular disease, hypertension, lower leg injury, sleep disorders
Drug, supplement and caffeine intake at least 48 hours before the test
Age
From 25 years old to 29 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
NO
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil university of medical science, University avenue, Ardabil
City
َArdabi
Province
Ardabil
Postal code
5618985991
Approval date
2019-07-21, 1398/04/30
Ethics committee reference number
IR.ARUMS.REC.1398.188
Health conditions studied
1
Description of health condition studied
.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Factor VIII
Timepoint
Before supplementation, before and immediately after exercise.
Method of measurement
Use the French Stage Kit by Coagulation Method and Using the Deficient Plasma
2
Description
Fibrinogen
Timepoint
Before supplementation, before and immediately after exercise.
Method of measurement
Using Quantitative Fibrinogen Kit (Mahsa Yaran Iran) by Quantitative Method
3
Description
Systolic and diastolic blood pressure
Timepoint
Before supplementation, before and immediately after exercise.
Method of measurement
Emsig Model Digital Barometer Manufacturing Made in Japan
4
Description
Thromboplastin time
Timepoint
Before supplementation, before and immediately after exercise.
Method of measurement
using a French Stage Kit with an ACI 7000 device, using a coagulometric method
5
Description
Prothrombin time
Timepoint
Before supplementation, before and immediately after exercise.
Method of measurement
using a French Stage Kit with an ACI 7000 device, using a coagulometric method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group 500 mg of garlic supplementation and acute endurance activity
Category
N/A
2
Description
Intervention group: Group 750 mg of garlic supplementation and acute endurance activity
Category
N/A
3
Description
Intervention group: Group 1000 mg of garlic supplementation and acute endurance activity
Category
N/A
4
Description
Intervention group: Placebo group and acute endurance activity
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Sport Club
Full name of responsible person
Ameneh Pourrahim Ghouroghchi
Street address
Mohaghegh Ardabili University, University blv.
City
Ardabil
Province
Ardabil
Postal code
56199-11367
Phone
+98 45 3150 5647
Fax
+98 45 3150 0427
Email
amenehpoorrahim@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistant-The university of Mohaghegh Ardabili
Full name of responsible person
Azim Omidvar
Street address
Ardabil, University Avenue
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5050
Email
Azim_omidvar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant-The university of Mohaghegh Ardabili
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
The university of Mohaghegh Ardabili
Full name of responsible person
Ameneh Pourrahim Ghouroghchi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
University Ave
City
Ardabil
Province
Ardabil
Postal code
56199-11367
Phone
+98 45 3150 5647
Email
amenehpoorrahim@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of Mohaghegh
Full name of responsible person
Ameneh pourrahim ghouroghchi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
University Ave
City
Adrabil
Province
Ardabil
Postal code
56199-11367
Phone
+98 45315647
Email
amenehpoorrahim@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The university of Mohaghegh Ardabili
Full name of responsible person
Ameneh Pourrahim Ghouroghchi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
University Ave
City
Ardabil
Province
Ardabil
Postal code
56199-11367
Phone
+98 45 3150 5647
Email
amenehpoorrahim@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The effect of different doses of garlic supplementation on coagulation factors and blood pressure after an acute endurance exercise in young active men
When the data will become available and for how long
2020 summer
To whom data/document is available
All
Under which criteria data/document could be used
with refernce
From where data/document is obtainable
Internet
What processes are involved for a request to access data/document