Protocol summary

Summary
The present study has been designed to investigate the effects of pomegranate seed oil (PSO) on insulin resistance, serum concentrations of systemic and vascular inflammatory markers, adipokines and lipid profile in type 2 diabetic patients . it is a randomized, double-blind and placebo-controlled trial .eighty subjects are recruited from an endocrine clinic sequentially and randomly assigned into two groups, the intervention (n =40) and control (n =40) groups.for all of whom demographic data and medical history at baseline will be documented, and subjects will be given capsules containing either PSO or placebo for eight weeks. The intervention group will consume PSO capsules, containing 1000 mg PSO twice daily (2000 mg PSO), while controls will take placebo capsules for eight weeks. Inclusion criteria are: willingness to work ; diabetes type 2 (for 5 to 10 years) ;age between 35 and 65 years; BMI between 20 to30. Exclusion criteria are: supplementation with antioxidant and anti-inflammatory drugs during the past month ;weight loss diets;not medication compliance ; patient with severe hyperglycemia (fasting glucose greater than 250);renal failure ; heart disease and liver failure . At the beginning and end of intervention after 12 to 14 hours of fasting, 10 ml of blood is taken from each patient . HbA1C levels will be measured by ion-exchange chromatography . Insulin, adiponectin, leptin, systemic inflammation, and vascular factors (including IL-6, hs-CRP, sICAM-1, sVCAM-1) will be determined by ELISA, serum triglyceride, total cholesterol, HDL-C and LDL-C will be measured enzymatically using autoanalyzer . Nutrition program and SPSS version 18 will be used respectively for dietary assay and analyzing.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201409031640N15
Registration date: 2015-05-16, 1394/02/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Parvin Mirmiran
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
mirmiran@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute Endocrine and Metaabolism Research Center,Isfahan university of Medical Sciences, Isfahan,Iran
Expected recruitment start date
2015-05-05, 1394/02/15
Expected recruitment end date
2015-07-06, 1394/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of pomegranate seed oil on insulin resistance, serum concentrations of systemic and vascular inflammatory markers, adipokines and lipid profile in type 2 diabetic patients
Public title
Effects of pomegranate seed oil in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : willingness to work diabetes type 2 (for 5 to 10 years) ;35 to 65 years of age;BMI between 20to30. Exclusion criteria: supplementation with antioxidant and anti-inflammatory drugs during the past month;weight-loss diets;not medication compliance; patient having severe hyperglycemia (fasting glucose greater than 250); renal failure; heart disease; liver failure
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
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
Ethical committee,National Nutrition and Food technology Institiute
Street address
National Nutrition and Food technology Institiute, Shahid hafezi street, Shahrak garb, Farahzadi Avenue, Tehran, Iran
City
Tehran
Postal code
19819619573
Approval date
2013-12-08, 1392/09/17
Ethics committee reference number
051526

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
fasting blood glucose
Timepoint
Begining and the end
Method of measurement
Enzymatic

Secondary outcomes

1

Description
total cholestrol
Timepoint
begining and the end of study
Method of measurement
enzymatically using autoanalyze

Intervention groups

1

Description
Intervention group: Pomegranate seed oil capsule, containing 1000 mg PSO, twice daily (2000 mg PSO) for 8 weeks
Category
Treatment - Drugs

2

Description
Control group:placebo capsules twice daily for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Endocrine&Metabolism Research Center
Full name of responsible person
Dr.Elham faghihimani
Street address
Sedigheh Tahereh Research Complex, Khorram Street, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Nutrition and Food Technology Institiute
Full name of responsible person
Dr.Parvin Mirmiran
Street address
National Nutrition and Food Technology Institiute, Shahid Hafezi street, Shahrak Garb, Farahzadi Avenue,Tehran, Iran
City
Tehran
Grant name
18
Grant code / Reference number
384
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology Institiute
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Isfahan endocrine&Metabolism Research Center
Full name of responsible person
Dr. Elham Faghihimani
Street address
Sedigheh Tahereh Research Complex, Khorram Street, 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
Isfahan endocrine&Metabolism Research Center
Proportion provided by this source
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
National Nutrition and Food Technology Institiute
Full name of responsible person
Dr.Parvin mirmiran
Position
PHD of nutrition
Other areas of specialty/work
Street address
National Nutrition and Food Technology Institiute, Shahid hafezi street, shahrak garb, Farahzadi Avenue, Tehran, Iran
City
Tehran
Postal code
19819619573
Phone
+98 21223574835
Fax
+98 21 2237 6467
Email
parvin.mirmiran@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
National Nutrition and Food Technology Institiute
Full name of responsible person
Dr.Parvin Mirmiran
Position
PHD of Nutrition
Other areas of specialty/work
Street address
National Nutrition and Food technology Institiute, Shahid Hafezi street, Shahrak garb, Farahzadi Avenue, Tehran, Iran
City
Tehran
Postal code
19819619573
Phone
+98 21223574835
Fax
+98 21 2237 6467
Email
parvin.mirmiran@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
National Nutrition and Food technology Institiute
Full name of responsible person
Dr.Parvin Mirmiran
Position
PHD of nutrition
Other areas of specialty/work
Street address
National nutrition and Food technology Institiute, Shahid hafezi street, Shahrak garb, Farahzadi Avenue,Tehran,Iran
City
Tehran
Postal code
19819619573
Phone
+98 21223574835
Fax
+98 21 2237 6467
Email
parvin.mirmiran@gmail.com
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
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