Some cell culture and animal studies have reported that pomegranate seed (PSO) have several health related benefits, but there is not enough information on the impact combined with exercise. Therefore, in this study was considered the effect of supplementation with pomegranate seed oil with resistance exercise on insulin resistance and lipid profile in non-athletes men. In a semi-experimental study with a double-blind randomized 14 non-athletes male were divided into two groups: exercise+supplementation (n = 7) and training+placebo (n = 7). Both groups performed resistance training program for 4 weeks (3 sessions per week). The experimental group consumed 2 capsules of 400 mg of pomegranate seed oil and the control group received 2 placebo. Glucose, fasting insulin, total cholesterol, triglycerides, LDL-C, HDL-C, were measured at the beginning and end of the study. Insulin resistance was estimated by the homeostasis Formula (HOMA-IR).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092730023N1
Registration date:2017-02-10, 1395/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Khalilullah Moonikh
Name of organization / entity
Rajai Teacher Training University
Country
Iran (Islamic Republic of)
Phone
+98 21 2297 0060
Email address
kh.moonikh@srttu.edu
Recruitment status
Recruitment complete
Funding source
Researchers
Expected recruitment start date
2016-12-10, 1395/09/20
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of pomegranate seed (PSO) with resistance exercise on insulin resistance and cardiovascular risk factors in non-athletic men
Public title
The effects of pomegranate seed (PSO) with resistance exercise on insulin resistance and cardiovascular risk factors in non-athletic men
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Healthy young men with no previous record of any specific drug use؛ without experience of regular physical activity in two year before beginning of the study. Exclusion Criteria: Unhealthy؛ Doing regular exercise during the last two years.
Age
From 21 years old to 23 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
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
Sport Sciences Research Institue of IRAN
Street address
NO 3, 5th alley, Miremad Ave, Tehran
City
Tehran
Postal code
Approval date
2015-11-04, 1394/08/13
Ethics committee reference number
IR.SSRI.IREC.1395.20
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Obesity
Primary outcomes
1
Description
Fasting insulin
Timepoint
Before and after 4 weeks
Method of measurement
Elisa
Secondary outcomes
1
Description
Lipid profiles (total cholesterol, triglycerides, and low high-density cholesterol)
Timepoint
Before and after 4 weeks
Method of measurement
Enzymatic
2
Description
Insulin resistance index
Timepoint
Before and after 4 weeks
Method of measurement
Elisa
Intervention groups
1
Description
400 mg doses of 2 capsules of pomegranate seed oil + RT
Category
Treatment - Drugs
2
Description
2 + placebo control group resistance training
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajai Teacher Training University
Full name of responsible person
Fereshte Shahidy
Street address
Rajai Teacher Training University, Lavizan, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajai Teacher Training University
Full name of responsible person
Khalil ollah Moonikh
Street address
Rajai Teacher Training University, St.Shabanlo, Lavizan, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajai Teacher Training 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
Rajai Teacher Training University
Full name of responsible person
Khalil ollah Moonikh
Position
PhD student of exercise physiology
Other areas of specialty/work
Street address
Rajai Teacher Training University, St.Shabanlo, Lavizan, Tehran
City
Tehran
Postal code
Phone
+98 21 2297 0060
Fax
Email
kh.moonikh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajai Teacher Training University
Full name of responsible person
Fereshte Shahidi
Position
Assistant Professor of exercise physiology
Other areas of specialty/work
Street address
Rajai Teacher Training University, St.Shabanlo, Lavizan, Tehran
City
Tehran
Postal code
Phone
+98 21 2297 0060
Fax
Email
Fe-shahidi@srttu.edu
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rajai Teacher Training University
Full name of responsible person
Khalil ollah Moonikh
Position
PhD student of exercise physiology
Other areas of specialty/work
Street address
Rajai Teacher Training University, St.Shabanlo, Lavizan, Tehran
City
Tehran
Postal code
Phone
+98 21 2297 0060
Fax
Email
kh.moonikh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)