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Comparing the effects of supplementation Krstyn, Vitamin C, endothelial function, oxidative stress, exercise performance, Indicators of inflammation and muscle damage in athletes

Protocol summary

Summary
The purpose of this double blind randomized clinical trial is to compare the effects of quercetin supplements, vitamin C and both Vit. C and quercetin composition on endothelial function, oxidative stress, athletic performance, indicators of inflammation and muscle damage in athletes. In this study, 60 athletes from the university student athletes who meet inclusion criteria are randomly assigned into one of the intervention or control groups. The participants in the intervention group will receive 500 mg of quercetin capsules a day or 25 mg of vitamin c or both and placebo groups will receive one capsule (containing lactose) daily for 8 weeks. Athletic performance, body mass index, SVCAM , PAI-1, SICAM-1، E-selectin CRP, traveled distance, time to exhaustion, heart rate, blood lactic acid, IL-1B, IL-2, IL-6, TNF-α, creatine kinase C, aspartate amino transfrase will be measured and compared forbetween the four groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112055062N4
Registration date: 2011-12-23, 1390/10/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-23, 1390/10/02
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
2011-11-22, 1390/09/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of supplementation Krstyn, Vitamin C, endothelial function, oxidative stress, exercise performance, Indicators of inflammation and muscle damage in athletes
Public title
Comparing the effects of supplementation Krstyn, Vitamin C, endothelial function, oxidative stress, exercise performance, Indicators of inflammation and muscle damage in athletes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study, male, students of Isfahan University of Medical Sciences, a history of continuous exercise at least 3 years of experience, the use of antioxidant supplements in the previous month Exclusion criteria: less than 70% adherence, presence of diseases requiring special treatment
Age
From 18 years old to 30 years old
Gender
Male
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)
Double 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
Hezargerib street, Isfahan
City
Isfahan
Postal code
00982181745319
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
390358

Health conditions studied

1

Description of health condition studied
sport medicine
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
VO2max
Timepoint
before and after intervention
Method of measurement
Gas Analyzor

2

Description
traveled distance
Timepoint
before and after intervention
Method of measurement
gaz analysor

3

Description
time to reach fatigue
Timepoint
before and after intervention
Method of measurement
Gas Analyzor

4

Description
heart rate
Timepoint
before and after intervention
Method of measurement
Gas Analyzor

5

Description
SVCAM
Timepoint
before and after intervention
Method of measurement
Elisa

6

Description
PAI-1
Timepoint
before and after intervention
Method of measurement
Elisa

7

Description
SICAM-1
Timepoint
before and after intervention
Method of measurement
Elisa

8

Description
E-selectin
Timepoint
before and after intervention
Method of measurement
Elisa

9

Description
crp
Timepoint
before and after intervention
Method of measurement
elisa

10

Description
F2-Isoprostane
Timepoint
before and after intervention
Method of measurement
elisa

11

Description
blood lactic acid
Timepoint
before and after intervention
Method of measurement
lactometer

12

Description
IL-1B
Timepoint
before and after intervention
Method of measurement
Elisa

13

Description
IL-2
Timepoint
before and after intervention
Method of measurement
elisa

14

Description
IL-6
Timepoint
before and after intervention
Method of measurement
Elisa

15

Description
TNF-α
Timepoint
before and after intervention
Method of measurement
Elisa

16

Description
CK
Timepoint
before and after intervention
Method of measurement
Chimical coloremetric

17

Description
ASP
Timepoint
before and after intervention
Method of measurement
PHOTOMETERIC

Secondary outcomes

empty

Intervention groups

1

Description
Control Group: Group 4: 1 capsule of 500 mg Krstyn placebo tablet daily and a placebo vitamin C tablet
Category
Treatment - Drugs

2

Description
Intervention group: Group 1: 1 capsule of 500 mg Krstyn supplement daily and 1 tablet of 250 mg vitamin C
Category
Treatment - Drugs

3

Description
Intervention group: Group 2: one capsules of 500 mg Krstyn supplements daily and a placebo tablet of vitamin C
Category
Treatment - Drugs

4

Description
Intervention group: Group 3: daily, one capsule of 500 mg Krstyn placebo and 1 vitamin C tablets
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
committee of sport medicine
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Isfahan University of Medical Sciences field
Full name of responsible person
Peyman Adibi doctor
Street address
Isfahan University of Medical Sciences, Hezarjarib St,Isfahan,
City
Esfahan
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 field
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Reza Ghiasvand doctor
Position
Ph.D. in Nutritional Sciences
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences.Hezarjarib St
City
Esfahan
Postal code
Phone
+98 31 1792 2742
Fax
Email
ghiasvand@hlth.mui.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

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