1. Home
  2. Approved trials
  3. » فارسی

Effects of Eicosapentaenoic Acid and Vitamin E Supplementation On Serum Lipid Profile, Blood Pressure, Antioxidant Status and Inflammatory Responses in Male Athletes

Protocol summary

Summary
Purpose: Investigation the effects of Eicosapentaenoic acid (EPA) supplementation, with or without vitamin E, on serum lipid profile, C-reactive protein(CRP), total antioxidant capacity, vitamin C, E and A, IL-6, and glutathione peroxidase activity in basketball players. Inclusion criteria: Healthy and athlete males with age between 17-35 year; not taking anti-oxidants 2 weeks before introducing to intervention. Exclusion criteria: Persons who treated with immunosupressor drugs; Persons who do not want to continue intervention. Total sample was 34 from healthy, well-trained male Participants received 2 g EPA and/or 400 IU vitamin E and/or placebo depending on their groups from 2011-2012. For 6 weeks,eight subjects received an EPA supplement with vitamin E (group 1), nine subjects received an EPA supplement with vitamin E placebo (group 2), nine subjects received an EPA supplement placebo and vitamiE (group 3), and eight subjects received an EPA supplement placebo and vitamin E placebo (group 4).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201211175062N6
Registration date: 2012-11-28, 1391/09/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-28, 1391/09/08
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
Food Security Research Center, Department of Community Nutrition, School of Nutrition and Food Science, University of Medical Sciences, Isfahan, Iran
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Eicosapentaenoic Acid and Vitamin E Supplementation On Serum Lipid Profile, Blood Pressure, Antioxidant Status and Inflammatory Responses in Male Athletes
Public title
Effects of Eicosapentaenoic Acid and Vitamin E Supplementation On Serum Lipid Profile and Antioxidant Status
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Healthy and athlete males with age between 17-35 year; not taking anti-oxidants 2 weeks before introducing to project Exclusion criteria: Persons who treated with immunosupressor drugs; Persons who do not want to continue project
Age
From 17 years old to 35 years old
Gender
Male
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 34
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Ethics Committee of Tehran University of Medical Sciences, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Approval date
2006-01-03, 1384/10/13
Ethics committee reference number
132/8596

Health conditions studied

1

Description of health condition studied
Serum Lipid Profile, Blood Pressure, Antioxidants Status and Iflamatory Responses
ICD-10 code
R70-R79
ICD-10 code description
Abnormal findings on examination of blood, without diagnosis

Primary outcomes

1

Description
Total Cholestrol
Timepoint
Before and 6 weeks after intervention
Method of measurement
ELISA

2

Description
LDL
Timepoint
Before and 6 weeks after intervention
Method of measurement
ELISA

3

Description
TG
Timepoint
Before and 6 weeks after intervention
Method of measurement
ELISA

4

Description
CRP
Timepoint
Before and 6 weeks after intervention
Method of measurement
ELISA

Secondary outcomes

1

Description
Vitamin E,Vit C,Vit A,IL-6, Glutathion Peroxidase Activity
Timepoint
Before and 6 weeks after project
Method of measurement
Assesment of variables in venus blood level, after 2 hour activity in first day and after 6 weeks

Intervention groups

1

Description
Group 1 received an 2gr EPA supplement with 400 IUvitamin E For 6 Weeks
Category
Treatment - Drugs

2

Description
Group 2 received an2 gr EPA supplement with400IU vitamin E placebo For 6 Weeks
Category
Treatment - Drugs

3

Description
Group 3 received an 2gr EPA supplement placebo and 400IU vitamin E For 6 weeks
Category
Treatment - Drugs

4

Description
Group 4 received an 2 grEPA supplement placebo and 400IU vitamin E placebo For 6 weeks
Category
Treatment - Drugs

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
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
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Food Security Research Center, Department of Community Nutrition, School of Nutrition and Food Scien
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
Food Security Research Center, Department of Community Nutrition
Full name of responsible person
Reza Ghiasvand
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Community Nutrition, Department of Nutrition and Food Science, Isfahan University of Medical Sciences, Hezar Jerib St, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1792 2742
Fax
Email
ghiasvand@hlth.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Food Security Research Center, Department of Community Nutrition
Full name of responsible person
Reza Ghiasvand
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Community Nutrition, Department of Nutrition and Food Science, Isfahan University of Medical Sciences, Hezar Jerib St, Isfahan, Iran
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
Food Security Research Center, Department of Community Nutrition
Full name of responsible person
Reza Ghiasvand
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Community Nutrition, Department of Nutrition and Food Science, Isfahan University of Medical Sciences, Hezar Jerib St, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1792 2742
Fax
Email
ghiasvand@hlth.mui.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
Loading...