Protocol summary

Summary
object: The effects of BlackBerry (Morus nigra L.) consumption on serum concentration of lipoproteins , APO A1 , APO B and hs – CRP and blood pressure in dyslipidemic patients. This study is a randomized, single-blind,multiple center with control group in the phase 3 of clinical trial. inclusion criteria: ; informed consent; dislipidemia ( cholesterol > 200 mg/dl and LDL > 100 mg/dl );BMI between 20-35;age between 18-65;no consumption of any drugs affecting lipid metabolism; no consumption antioxidant supplements of at least one month prior to study entry and during study; lack of any systematic disease,inflammation ,choronic or liver and kidney disease;no pregnancy or lactation;lack of sensivity to the blackberry. Exclusion criteria: not wanting Collaboration; changes in food pattern ; systematic or choronic disease during the study; LDL higher than 160 mg/dl and necessity to medication under specialist .72 Eligible patients randomaly divided into two groups, intervention and control groups;individuals in intervention group receive 300 gr BlackBerry daily for 8 weeks and individuals in control group are asked to continue their usual diet without eating berries. The primary expected outcomes are changes in serum level of lipoproteins,Apo A1,Apo B,hs-CRP and blood pressure compared with baseline in the intervention group and the control before and after of intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205182365N7
Registration date: 2012-06-04, 1391/03/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-06-04, 1391/03/15
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of BlackBerry (Morus nigra L.) consumption on serum concentration of lipoproteins , APO A1 , APO B and hs – CRP and blood pressure in dyslipidemic patients
Public title
The effects of BlackBerry (Morus nigra L.) consumption on serum concentration of lipoproteins , APO A1 , APO B and hs – CRP and blood pressure in dyslipidemic patients
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: informed consent; dislipidemia ( cholesterol > 200 mg/dl and LDL > 100 mg/dl );BMI between 20-35;age between 18-65; no consumption of any drugs affecting lipid metabolism; no consumption of antioxidant supplements of at least one month prior to study entry and during study lack of any systematic disease,inflammation ,choronic or liver and kidney disease;no pregnancy or lactation;no smoking and use of alcoholic beverages;lack of sensivity to the blackberry. Exclusion criteria: not wanting Collaboration; changes in food pattern ; systematic or choronic disease during the study; LDL higher than 160 mg/dl and necessity to medication under specialist.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Sixth Floor,Central Organization of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd
City
Tehran
Postal code
Approval date
2012-05-16, 1391/02/27
Ethics committee reference number
130/2828/د/90

Health conditions studied

1

Description of health condition studied
dislipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified

Primary outcomes

1

Description
Total cholesterol
Timepoint
Before and after intervention
Method of measurement
Colorimetric

2

Description
LDL-cholesterol
Timepoint
Before and after intervention
Method of measurement
Colorimetric

3

Description
HDL-cholesterol
Timepoint
Before and after intervention
Method of measurement
Colorimetric

4

Description
TG
Timepoint
Before and after intervention
Method of measurement
Colorimetric

5

Description
APO A1
Timepoint
Before and after intervention
Method of measurement
turbidimetry

6

Description
APO B
Timepoint
Before and after intervention
Method of measurement
turbidimetry

7

Description
hs-CRP
Timepoint
Before and after intervention
Method of measurement
ELISA

8

Description
Systolic blood pressure
Timepoint
Before and after intervention
Method of measurement
Mercury barometer

9

Description
Diastolic blood pressure
Timepoint
Before and after intervention
Method of measurement
Mercury barometer

Secondary outcomes

1

Description
weight
Timepoint
Before and after intervention
Method of measurement
scale

2

Description
height
Timepoint
Before and after intervention
Method of measurement
meter

3

Description
BMI
Timepoint
Before and after intervention
Method of measurement
mathematics

4

Description
Waist circumference
Timepoint
Before and after intervention
Method of measurement
meter

5

Description
Energy intake
Timepoint
Before and after intervention
Method of measurement
recall

6

Description
Protein intake
Timepoint
Before and after intervention
Method of measurement
recall

7

Description
Carbohydrate intake
Timepoint
Before and after intervention
Method of measurement
recall

8

Description
fat intake
Timepoint
Before and after intervention
Method of measurement
recall

9

Description
cholesterol intake
Timepoint
Before and after intervention
Method of measurement
recall

10

Description
fiber intake
Timepoint
Before and after intervention
Method of measurement
recall

11

Description
Vitamin A
Timepoint
Before and after intervention
Method of measurement
recall

12

Description
Vitamin C
Timepoint
Before and after intervention
Method of measurement
recall

13

Description
Vitamin E
Timepoint
Before and after intervention
Method of measurement
recall

14

Description
sodium
Timepoint
Before and after intervention
Method of measurement
recall

15

Description
potasium
Timepoint
Before and after intervention
Method of measurement
recall

16

Description
fruit and vegetables intake
Timepoint
Before and after intervention
Method of measurement
recall

17

Description
level of physical activity
Timepoint
Before and after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Black berry , 300 gr , once a day for 8 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tamin ejtemaei clinic ,Razi hospital
Full name of responsible person
Dr Davood Katebi
Street address
Razi hospital-shahid babaei St-Qazvin
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Aliakbar Fotouhi
Street address
Research section-Tehran University of Medical Sciences- Ghods st- Keshavarz Blvd- Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Nutrition-School of Public Health- Tehran University of Medical Sciences-Alvand st.- Argentine Square- Tehran
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
rezavafa@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Vafa
Position
PhD of Nutrition sciences
Other areas of specialty/work
Street address
Department of Nutrition- Health school- Tehran University of Medical Sciences-Alvand st.- Argentine Square- Tehran
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
mrvafa@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Vafa
Position
PhD of Nutrition sciences
Other areas of specialty/work
Street address
Department of Nutrition- Health school- Tehran University of Medical Sciences-Alvand st.- Argentine Square- Tehran
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
mrvafa@tums.ac.ir
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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