This Study Has Been Designed to Assess the Effect of Amygdalus Oil on Lipid Profile in Patients Suffering from Dyslipidemia Referred to the Health Heart House, Affiliated to Shiraz Cardiovascular Research Center. In This Randomized Controlled Clinical Study 80 People Suffering from Dyslipidemia Age Between 20-70 Referred to Shiraz Heart House Have Been Selected According to the Inclusion criteria: Low Density Lipoprotein (LDL) between 130-169 or High-Density Lipoprotein (HDL) in Females under 50 and Males under 40 or triglyceride between 200-400 and the Use of no Untilipidemic Drugs. The Exclusion criteria have been Pregnancy; breastfeeding; the Use of Oral Contraceptive Pills (OCP) and Antilipidemic Drugs.These Persons Have Randomly been Divided into Experiment Group (40 persons) Receiving Amygdalus Oil and Control Group (40 persons). The Experiment Group has been Given 20 cc of Amygdalus Oil Daily for One Month and the Control Group has not Received any Intervention During This Period. At the End, Total Cholesterol, Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL) and Triglyceride before and after Intervention have been Checked and Compared with Each Other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411141525N4
Registration date:2015-02-04, 1393/11/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-04, 1393/11/15
Registrant information
Name
Mohammad Javad Zibaeenezhad
Name of organization / entity
Cardiovascular Research Center, Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1234 3529
Email address
zibaeem2@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-11-21, 1393/08/30
Expected recruitment end date
2014-12-06, 1393/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Amygdalus Oil Consumption on Lipid Profile in Patients with Dyslipidemia
Public title
Effect of Amygdalus Oil Consumption on Lipid Profile in Patients with Dyslipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 20 -70 year old; Low-density Lipoprotein(LDL) 130-169 or Triglyceride 200-400 or High- density Lipoprotein (HDL) Less 50 in Female and Less 40 in Male; Non-use Antilipidemic Drugs; Non History of Renal, Liver, Kidney, Heart, Thyroid, Diabetes mellitus Diseases; Non History of Food Allergy Especially to Amygdalus.
Exclusion criteria: Breastfeeding and Pregnancy; Use of Antilipideimic Drugs; Alcohol Consumption; Hospitalization During Study.
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:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Science
Street address
Shiraz University of Medical Science, Zand St.
City
Shiraz
Postal code
7134814336
Approval date
2014-11-16, 1393/08/25
Ethics committee reference number
92-01-0105869
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78
ICD-10 code description
Disorders of Llipoprotein Metabolism and Other Lipidaemias
Primary outcomes
1
Description
Low Density Lipoprotein
Timepoint
Before Intervention and One Month After Intervention
Method of measurement
Biochemical Measurements on Blood Sample
2
Description
Serum Total Cholesterol
Timepoint
Before Iintervention and One Month After Intervention
Method of measurement
Biochemical Measurements on Blood Sample
3
Description
High Density Lipoprotein
Timepoint
Before Intervention and One Month After Intervention
Method of measurement
Biochemical Measurements on Blood Sample
Secondary outcomes
1
Description
Serum Triglyceride
Timepoint
Before Intervention and One Month After Intervention
Method of measurement
Biochemical Measurements on Blood Sample
Intervention groups
1
Description
Intervention Group: Use Amygdalus Oil Orally 20 cc per Day for 30 Days
Category
Treatment - Other
2
Description
Control group: No Iintervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiovascular Research Center of Shiraz University of Medical Sciences
Full name of responsible person
Parham Ostovan
Street address
Cardiovascular Research Center, Khalili St, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical of Science
Full name of responsible person
Mrs. Hoghooghi
Street address
Cardiovascular Research Center, Khalili St, shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical of Science
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
Shiraz University of Medical Sciences
Full name of responsible person
Parham Ostovan
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, zand St, shiraz
City
shiraz
Postal code
7134814336
Phone
+98 71 3628 1561
Fax
Email
parham.ostovan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cardiovascular Research Center of Shiraz
Full name of responsible person
Dr. Mahmood Zamirian
Position
Internist Cardiologist
Other areas of specialty/work
Street address
Cardiovascular Research, Khalili St, Shiraz
City
shiraz
Postal code
7193635899
Phone
+98 71 3628 1561
Fax
Email
zmirian@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Parham Ostovan
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Shiraz University of Medical Science, Zand St, Shiraz
City
Shiraz
Postal code
7134844119
Phone
+98 71 3628 1561
Fax
Email
parham.ostovan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)