Protocol summary

Summary
According to current knowledge, several studies has been conducted separately concerning the relationship between garlic and lemon juice in reducing inflammatory biomarkers and lipid profile in patients with cardiovascular disease. But yet, the effects of garlic and lemon juice mixture over the indices of cardiovascular disease is not analyzed, and regarding the high and increasing prevalence of these diseases in the world and in Iran, the aim of present study is to investigate effect of garlic and lemon juice mixture on lipid profile and some cardiovascular risk factors.people with hyperlipidemia according to the inclusion criteria were selected and randomly divided into 4 groups and control blood samples were taken, height, weight and blood pressure were recorded, first group received 20 grams of garlic daily, plus 1 tablespoon lemon juice, second 20 g garlic daily , third group 1 tablespoon lemon juice daily2 hours after dinner and forth group did not receive garlic and lemon juice during the intervention. Experiments were repeated after 2 month, the results were analyzed the SPSS softwere.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015020720986N1
Registration date: 2015-03-07, 1393/12/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-03-07, 1393/12/16
Registrant information
Name
Negar Aslani
Name of organization / entity
Isfahan Univercity Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 3433 2929
Email address
negar_aslani@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Science
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of garlic and lemon juice mixture on lipid profile and some cardiovascular risk factors in people 30-60 years old with hyperlipidemia.
Public title
Effect of mixed of garlic and lemon juice on hyperlipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Subjects were eligible if they have a total cholesterol and LDL levels between 240-200 mmol/l and 160-100 mmol/l respectively. People should not be suffering from any other diseases, including heart problems, kidney, lung, thyroid disorders, gastrointestinal, rheumatoid arthritis and other liver problems such as hepatitis or fatty liver, pregnancy or lactating, no smoking, their weight may not change fast in the last two months, should not use drugs that affect blood sugar, blood fat, blood pressure and anti-inflammatory and not to have any sensitivity to garlic and lemon juice. Individual with a history of chronic disease, consuming medicine and flowing special regimen were excluded.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jarib street
City
Isfahan
Postal code
Approval date
2013-10-28, 1392/08/06
Ethics committee reference number
392436

Health conditions studied

1

Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.0
ICD-10 code description
Disorders of lipoprotein metabolism and other lipidaemias

Primary outcomes

1

Description
total cholesterol
Timepoint
in the first of intervention and end of 8th week
Method of measurement
enzymatic, mg/dl

2

Description
Serum low-density lipoprotein cholesterol (LDL-C) levels
Timepoint
Before intervention and at the end of 8th week
Method of measurement
Enzymatic, mg/dl

3

Description
Serum hight-density lipoprotein cholesterol (HDL-C) levels
Timepoint
Before intervention and at the end of 8th week
Method of measurement
Enzymatic, mg/dl

4

Description
triglyceride
Timepoint
in the first of intervention and end of 8th week
Method of measurement
Enzyme colorimetric methods, mg/dl

5

Description
Fibrinogen
Timepoint
Before intervention and at the end of 8th week
Method of measurement
Clauss method

6

Description
Systolic blood pressure
Timepoint
Before intervention and at the end of 8th week
Method of measurement
mmHg, Mercurial sphygmomanometer

7

Description
Diastolic blood pressure
Timepoint
Before intervention and at the end of 8th week
Method of measurement
mmHg, Mercurial sphygmomanometer

8

Description
Body mass index
Timepoint
Before intervention and at the end of 8th week
Method of measurement
kg/m2, Weight/Height squar

9

Description
Fasting blood sugar
Timepoint
Before intervention and at the end of 8th week
Method of measurement
Enzymatic, mg/dl

10

Description
Weight
Timepoint
Before intervention and at the end of 8th week
Method of measurement
Scale, kilogram

Secondary outcomes

empty

Intervention groups

1

Description
first group received 20 grams of garlic plus 1 tablespoon lemon juice daily
Category
Prevention

2

Description
forth group did not recive garlic and lemon juice during the intervention
Category
Prevention

3

Description
second group recived 20 gram of garlic, daily
Category
Prevention

4

Description
third group recived 1 tablespoon of lemon juice, daily
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Cardiovascular Research Center
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Science
Full name of responsible person
Peyman Adibi
Street address
Isfahan University of Medical Science, Hezar Jerib Avenue
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Science
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 University of Medical Sciences, School of Nutrition-School Nutrition Research Center
Full name of responsible person
Miss Samadanian
Street address
School Nutrition Research Center, School of Nutrition and Food Sciences, Isfahan university Of Medical Sciences, Hezar Jerib Street, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, School of Nutrition-School Nutrition 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
Isfahan University of Medical Sciences
Full name of responsible person
Negar Aslani
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Department of Clinical nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Scienses, Hezar Jerib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3433 2929
Fax
Email
negar_aslani@nutr.mui.ac.ir; negaraslani5@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan university of Medical Sciences
Full name of responsible person
Negar Aslani
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Department Of clinical Nutrition, School Of Nutrition and Food Sciences, Isfahan University Of Medical Sciences, Hezar Jerib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3433 2929
Fax
Email
negar_aslani@nutr.mui.ac.ir; negaraslani5@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Negar Aslani
Position
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3433 2929
Fax
negar_aslani@nutr.mui.ac.ir
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
empty
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