Protocol summary

Summary
Effect of Pomegranate Supplementation with Aerobic Training on Total Antioxidant Capacity and Lipid Peroxidation in Overweight Males. Oxidative stress is a source of many diseases, especially in obese patients. Recently, the use of herbal supplements polyphenols to prevent free radicals has been proved. The purpose of this study was to determine the effect of long-term pomegranate supplementation on Antioxidant activity and Lipid peroxidation in overweight males. Subjects have Body Mass Index of 25 to 28; male; no history of diseases included. Participants were excluded if in case of: absence of more than three exercise sessions; Sick or injured during exercise training; Unwillingness to take part in exercise. Double blind randomized clinical trials on 20 participants in 2 groups (intervention & Placebo) are selected. The participant in Intervention group were administered to take pomegranate supplementation (1 capsule daily) for a total of 8 weeks. The Control group was Placebo Capsule (200 mg daily). Each pomegranate Capsule contain 200 Mg (80 mg Ellagic Acid, 50 mg Punicalagin, 40 mg Punicalin, 20 mg Anthocyanin, and 10 mg Flavonoid). The subjects participated in an exercise for eight weeks (three sessions a week) running test with 70% VO2max. Blood samples were collected from the antecubital vein of the subjects at baseline, after 4 and 8 weeks to assess Total Antioxidant Capacity and Lipid Peroxidation. Research findings showed that although exercise can lead to antioxidant system improvement and reduce Molondealdeid among overweight subjects, the combination of aerobic training and pomegranate consumption is more effective.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014070918415N1
Registration date: 2014-11-16, 1393/08/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-16, 1393/08/25
Registrant information
Name
Hassan Farhady
Name of organization / entity
University of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 42 6222 8211
Email address
hfarhadi@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Mohageg Ardabili
Expected recruitment start date
2013-07-01, 1392/04/10
Expected recruitment end date
2013-09-01, 1392/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pomegranate Supplementation and Aerobic Training on Total Antioxidant Capacity and Lipid Peroxidation in Overweight Male.
Public title
Effect of Pomegranate Supplementation and Aerobic Training on Total Antioxidant Capacity
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion: Body Mass Index 25 to 28; male; no history of diseases. Exclusion: absence of more than three exercise sessions; Sick or injured during exercise training; Unwillingness to participate in exercise
Age
From 20 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
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
University of Mohageg Ardabili
Street address
university Ave, University of Mohageg Ardabili
City
Ardabil
Postal code
Approval date
2013-06-08, 1392/03/18
Ethics committee reference number
1094463

Health conditions studied

1

Description of health condition studied
The Relationship Between Pomegranate Supplementation with Aerobic Training on Total Antioxidant Capacity and Lipid Peroxidation in Overweight Males
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Total Antioxidant Capacity
Timepoint
3 Stage
Method of measurement
Ransod kit manufactured by Randox, UK, Cat No. NX 2331, spectrophotometer

Secondary outcomes

1

Description
Malondialdeid
Timepoint
3 Stage
Method of measurement
Using thiobarbituric acid reactive substance (TBARS) and was measured by Satoh.

Intervention groups

1

Description
Experimental Group: Pomegranate Supplementation,200mg per day for 2 month
Category
Placebo

2

Description
Placebo Group, Dexterous 200mg per day for 2 month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Azad University, Ahar branch
Full name of responsible person
Street address
City
Ahar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mohageg Ardabil University
Full name of responsible person
Hasan Farhady
Street address
University Ave, Mohageg Ardabil University, Ardabil
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mohageg Ardabil University
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
Azad University, Ahar branch
Full name of responsible person
Hasan Farhadi
Position
Head of Departement, PhD Student
Other areas of specialty/work
Street address
Emam Ave, Next Big bridge, Varzegan City, Tabriz
City
Varzegan
Postal code
Phone
+98 41 4455 4910
Fax
Email
hassan_farhady@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mohageg Ardabil University
Full name of responsible person
Soheila Rahimifardin
Position
Ms
Other areas of specialty/work
Street address
Emam Ave, Next big bridge, Varzegan City, Tabriz
City
Varzegan
Postal code
Phone
+98 41 4455 4910
Fax
Email
hassan_farhady@yahoo.com; soheila_fardin@yahoo.com
Web page address

Person responsible for updating data

Contact

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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