Protocol summary

Summary
This study is a randomised controlled trial to determine the effect of Black Raisin on some cardiovascular risk factors, serum levels of Malondialdehyde (MDA) and total antioxidant capacity in 40 male and female patients with hyperlipidemia Referred to The Neshat clinic of Dezful county. The criteria for entering to this research are included : patients with Cholesterol above 200 milligrams per deciliter or Triglycerides above 150 mg per deciliter and The criteria for extracting to this research are included : Pregnant, liver disease, kidney disease, Hypothyroidism and Hyperthyroidism, Myocardial Infarction and Diabetes .Patients randomly are placed in two groups of intervention (n = 20) and ontrol (n = 20). Intervention group consumes 90 gram black Raisin daily for 5 weeks and the control group receives no intervention. Amount of energy and macronutrients received via Raisins are Replaced in intervention group. Anthropometric measurements, blood pressure, physical activity and 24-hour Dietary Recall are collected for three consecutive days at baseline and 5 weeks after the intervention . 10 cc blood will be taken after 12 to 14 hours of overnight fasting, at the beginning and after 5 weeks of Intervention. Biochemical analysis of Total Cholesterol, Triglycerides, LDL-C, HDL-C, LDL, will be done on fasting serum sampales ,as well as, serum levels of TAC and MDA will be evaluate. evaluating of Fibrinogen and factor VII on plasma samples will be done by related kits .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091624049N1
Registration date: 2015-10-27, 1394/08/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-27, 1394/08/05
Registrant information
Name
Parvin Joola Joola
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4253 0416
Email address
joola.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-09-29, 1394/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of black Raisin consumption on some cardiovascular risk factors, serum alonaldehyde and total antioxidant capacity in hyperlipidemic patients
Public title
Effect of black raisin consumption on some cardiovascular risk factors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hypercholesterolemia patients who have high cholesterol of 200 mg dL or triglyceride levels over 200 milligrams per deciliter. Exclusion criteria: Hepatic or renal disorders, hypothyroidism and hyperthyroidism, myocardial infarction, diabetes, as well as samples that consume antioxidants, Pregnancy or hormone therapy in women
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Jundi Shapour Of Medical Sciences
Street address
Golestan Blvd.
City
Ahvaz
Postal code
6135715794
Approval date
2010-06-20, 1389/03/30
Ethics committee reference number
1394.103.IR.AJUMS.REC

Health conditions studied

1

Description of health condition studied
Hyperlepidemia
ICD-10 code
E78
ICD-10 code description
Disorders of lipoprotein metabolism and other lipidaemias

Primary outcomes

1

Description
Height
Timepoint
Baseline
Method of measurement
wall meter

2

Description
blood pressure
Timepoint
at baseline and 5 weeks after the intervention
Method of measurement
Aneroid sphygmomanometer dial, bulb, and air valve

3

Description
Weight
Timepoint
at basline and 5 weeks after the intervention
Method of measurement
Kilogram and with digital weight scale

4

Description
serum triglycerid
Timepoint
at basline and 5 weeks after the intervention
Method of measurement
Methods of enzymatic analysis

5

Description
Serum total cholesterol
Timepoint
at basline and 5 weeks after the intervention
Method of measurement
Methods of enzymatic analysis

6

Description
Serum levels of HDL
Timepoint
at basline and 5 weeks after the intervention
Method of measurement
Methods of enzymatic analysis

7

Description
Serum levels of LDL
Timepoint
at basline and 5 weeks after the intervention
Method of measurement
Friedewald formula

8

Description
Plasma levels of fibrinogen
Timepoint
at basline and 5 weeks after the intervention
Method of measurement
special kits and analyzer vicheles

9

Description
Plasma levels of coagulation factor VII
Timepoint
at basline and 5 weeks after the intervention
Method of measurement
Clotting time and spicial kit

10

Description
Serum levels of hs-CRP
Timepoint
at basline and 5 weeks after the intervention
Method of measurement
ELISA Kits

11

Description
TAC , serum total antioxidant capacity
Timepoint
at basline and 5 weeks after the intervention
Method of measurement
Colorimetric Test Kits

12

Description
MDA , Malondialdehyde
Timepoint
at basline and 5 weeks after the intervention
Method of measurement
TBARS

Secondary outcomes

empty

Intervention groups

1

Description
intervention group consume 90 grams black raisin daily for 5 weeks and Amount of energy and macronutrients that are received via raisins are Replaced in intervention group Dietary.
Category
Other

2

Description
The control group receives no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Neshat clinic
Full name of responsible person
Dr Azam Sadeghinai
Street address
Enghelab ST. Neshat ST.
City
Dezful

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences, Vice Chancellor for Research and Technology
Full name of responsible person
Dr.Nader Saki
Street address
Golestan Blvd
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences, Vice Chancellor for Research and Technology
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
Ahvaz University of Medical Sciences
Full name of responsible person
Parvin Joola
Position
Master student of Nutrition Sciences
Other areas of specialty/work
Street address
Golestan Blvd
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 3373 8319
Fax
Email
joola.p@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Farideh Shishehbor
Position
Ph.D. Nutrition Sciences
Other areas of specialty/work
Street address
Golestan Blvd
City
Ahvaz
Postal code
1579461357
Phone
+98 61 3373 8319
Fax
Email
fari.shishehbor@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvin Joola
Position
Master student of Nutrition Sciences
Other areas of specialty/work
Street address
Golestan Blvd
City
Ahvaz
Postal code
1579461357
Phone
+98 61 3373 8319
Fax
Email
joola.p@ajums.ac.ir ,p.joola@yahoo.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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