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Evaluation of effects of pomegeranate seed oil on lipid profiles, apolipoproteines and body composition in subjects with low HDL-C concentrations

Protocol summary

Summary
The present study has been designed to investigate the effect of pomegranate seed oil (PSO) treatment on lipid profiles, apolipoproteins and body composition of subjects with low serum HDL-C levels. The study has a parallel, randomized, double-blind and placebo-controlled design. One hundred and fifty subjects with low HDL-C levels (serum HDL-C < 40 mg/dl) will be recruited from endocrine clinics using a sequential design and randomly assigned into 3 groups, 1600 mg PSO (n =50), 3200 mg PSO (n =50) and placebo (n =50) groups. For every patient, medical history including history of medication use will be obtained and a thorough physical examination will be performed. All subjects will be given capsules for twelve weeks. The 1600 mg PSO group will consume 2 PSO (800 mg PSO) capsules and 2 placebo capsules, The 3200 mg PSO group will consume 4 PSO capsules daily, while controls will take 4 placebo capsules. Measurements of anthropometric indexes, body composition, and blood pressure will be obtained at baseline and again 12 weeks after treatment. Physical activity and 3 consecutive dietary recalls will be obtained at baseline, and at the end of the weeks 6 and 12. After 12 to 14 hours overnight fasting, blood samples will be taken for biochemical analysis in days 1, 2 and at the end of weeks 2, 4, 8 and 12. Measurement of serum cholesterol, triglycerides, LDL-C, HDL-C, HDL-C2, HDL-C3, VLDL-C, Apo B100, Apo AI, Panicic acid and 9c, 11t CLA will be done in each sample.

General information

Acronym
pomegranate seed oil (PSO)
IRCT registration information
IRCT registration number: IRCT201107201640N5
Registration date: 2011-09-29, 1390/07/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-09-29, 1390/07/07
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
Obesity Research Center, Research Institute for Endocrine Science, Shaheed Beheshti University of Medical Sciences
Expected recruitment start date
2011-04-16, 1390/01/27
Expected recruitment end date
2011-12-18, 1390/09/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effects of pomegeranate seed oil on lipid profiles, apolipoproteines and body composition in subjects with low HDL-C concentrations
Public title
Evaluation of effects of pomegeranate seed oil on lipid profiles, apolipoproteines and body composition in subjects with low HDL-C concentrations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: willingness to cooperate; ages 20-70 years; those with 35≥ BMI (kg/m2) ≥25; having levels of HDL-C <40mgr/dl in the last 12 months; Who are placed in stage I and stage II on TLC, according to NCEP ATP III criteria; Diabetic people not used Glitazones and insulin or consume constantly oral diabetes medications for at least three months Even if taking anti-lipid medications (statins and fibers); Lack of breastfeeding and pregnancy; Those who have had less than 5 Kg in body weight in the last 3 months; Not having any thyroid disorders and kidney failure; Lack of any severe mental illness; Not having cancer in the past five years; Lack of peptic ulcer disease; No smoking and alcohol; Not using drugs affecting lipid profile such as corticosteroids, cyclosporine, propranolol and glucocorticoid. Exclusion criteria: weight loss >10Kg during the study, Diagnosis of any of the diseases mentioned in inclusion criteria, during the study; Patient's lack of cooperation in each of the stages studied.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
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
Research Institute for Endocrine Science, Shaheed Beheshti University of Medical Sciences
Street address
No.24, Parvaneh St, Yemen Blvd, Chamran highway
City
Tehran
Postal code
Approval date
2011-06-03, 1390/03/13
Ethics committee reference number
EC353

Health conditions studied

1

Description of health condition studied
low HDL-C concentrations
ICD-10 code
E78
ICD-10 code description
Disorders of lipoprotein metabolism and other lipidaemias

Primary outcomes

1

Description
low HDL-C
Timepoint
baseline and end of weeks 2, 4, 8 and 12.
Method of measurement
Enzymatic colorimetric method and sediment specific

Secondary outcomes

1

Description
body weight
Timepoint
at the start and end of the 12 weeks study.
Method of measurement
anthropometric measurements

2

Description
blood pressure
Timepoint
at the start and end of the 12 weeks study
Method of measurement
blood pressure measurement

Intervention groups

1

Description
The 1600 mg PSO group: 2 PSO (800 mg PSO) capsules and 2 placebo capsules.
Category
Treatment - Other

2

Description
The 3200 mg PSO group: 4 PSO capsules daily.
Category
Treatment - Drugs

3

Description
Control group: 4 placebo capsules.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Lipid Clinic of shahid Rajai Heart Hospital
Full name of responsible person
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
endocrine clinice of Talaghani Hospital
Full name of responsible person
Street address
City
Tehran

3

Recruitment center
Name of recruitment center
Iran Diabetes Association
Full name of responsible person
Street address
City
Tehran

4

Recruitment center
Name of recruitment center
Research Institue for Endocrine Science, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute for Endocrine Science, Shaheed Beheshti University of Medical Sciences
Full name of responsible person
Parvin Mirmiran
Street address
No.24, Parvaneh St, Yemen Blvd, Chamran highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Endocrine Science, Shaheed Beheshti University of Medical Sciences
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
Obesity Research Center, Research Institue for Endocrine Science, Shaheed Beheshti University of Med
Full name of responsible person
Parvin Mirmiran
Position
Director of Nutrition Unit of Obesity Research Center/ PhD in Nutrition
Other areas of specialty/work
Street address
No.24, Parvaneh St, Yemen Blvd, Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
mirmiran@endocrine.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Obesity Research Center, Research Institue for Endocrine Science, Shaheed Beheshti University of Med
Full name of responsible person
Parvin Mirmiran
Position
PhD in Nutrition
Other areas of specialty/work
Street address
No.24, Parvaneh St, Yemen Blvd, Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
mirmiran@endocrine.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
obesity research center, research institute for endocrine science, shaheed beheshti university of me
Full name of responsible person
Golaleh Asghari
Position
MSc in Nutrition
Other areas of specialty/work
Street address
No.24, Parvaneh St, Yemen Blvd, Chamran Exp
City
Tehran
Postal code
Phone
Fax
Email
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
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