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General information
empty
1. Add the duration of the intervention
2. Add more secondary outcome measures
1. Add the duration of the intervention 2. Add more secondary outcome measures
empty
1-اضافه کردن طول زمان مداخله
2-اضافه کردن اندازه گیری پیامد های ثانویه بیشتر
1-اضافه کردن طول زمان مداخله 2-اضافه کردن اندازه گیری پیامد های ثانویه بیشتر
Primary outcomes
#1
At the beginning of the study, the end of the second and fourth week
At the beginning of the study, the end of the second and eight week
At the beginning of the study, the end of the second and fourtheight week
درابتداي مطالعه، پايان هفته دوم ، وچهارم
درابتداي مطالعه، پايان هفته دوم ، وهشتم
درابتداي مطالعه، پايان هفته دوم ، وچهارموهشتم
#2
At the beginning of the study, the end of the second and fourth week
At the beginning of the study, the end of the second and eighth week
At the beginning of the study, the end of the second and fourtheighth week
درابتداي مطالعه، پايان هفته دوم ، وچهارم
درابتداي مطالعه، پايان هفته دوم ، هشتم
درابتداي مطالعه، پايان هفته دوم ، وچهارمهشتم
Secondary outcomes
#1
At the beginning of the study, the end of the second and fourth week
At the beginning of the study, the end of the second and eighth week
At the beginning of the study, the end of the second and fourtheighth week
درابتداي مطالعه، پايان هفته دوم ، وچهارم
درابتداي مطالعه، پايان هفته دوم ، وهشتم
درابتداي مطالعه، پايان هفته دوم ، وچهارموهشتم
#2
At the beginning of the study, the end of the second and fourth week
At the beginning of the study, the end of the second and eighth week
At the beginning of the study, the end of the second and fourtheighth week
درابتداي مطالعه، پايان هفته دوم ، وچهارم
درابتداي مطالعه، پايان هفته دوم ، وهشتم
درابتداي مطالعه، پايان هفته دوم ، وچهارموهشتم
#3
At the beginning of the study, the end of the second and fourth week
At the beginning of the study, the end of the second and eighth week
At the beginning of the study, the end of the second and fourtheighth week
درابتداي مطالعه، پايان هفته دوم ، وچهارم
درابتداي مطالعه، پايان هفته دوم ، وهشتم
درابتداي مطالعه، پايان هفته دوم ، وچهارموهشتم
#4
At the beginning of the study, the end of the second and fourth week
At the beginning of the study, the end of the second and eighth week
At the beginning of the study, the end of the second and fourtheighth week
At the beginning of the study, the end of the eighth week
At the beginning of the study, the end of the eighth week
empty
درابتداي مطالعه، پايان هفته هشتم
درابتداي مطالعه، پايان هفته هشتم
empty
Pars Azmon Kit
Pars Azmon Kit
empty
کیت پارس آزمون
کیت پارس آزمون
Recruitment centers
#1
Name of recruitment center - English: Pasargad Clinic
Name of recruitment center - Persian: درمانگاه پاسارگاد
Full name of responsible person - English: Narges Akramipour
Full name of responsible person - Persian: نرگس اكرامي پور
Street address - English: Shahroud - 28 m Street
Street address - Persian: شاهرود- خيابان 28 متري
City - English: shahroud
City - Persian: شاهرود
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3613773955
Phone: +98 23 3236 1718
Fax:
Email: delvarianzadeh_mehri@yahoo.com
Web page address:
Name of recruitment center - English: Pasargad Clinic
Name of recruitment center - Persian: درمانگاه پاسارگاد
Full name of responsible person - English: Narges Akramipour
Full name of responsible person - Persian: نرگس اكرامي پور
Street address - English: Shahroud - 28 m Street
Street address - Persian: شاهرود- خيابان 28 متري
City - English: Sُُhahroud
City - Persian: شاهرود
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3613773955
Phone: +98 23 3236 1718
Fax:
Email: delvarianzadeh_mehri@yahoo.com
Web page address:
Name of recruitment center - English: Pasargad Clinic Name of recruitment center - Persian: درمانگاه پاسارگاد Full name of responsible person - English: Narges Akramipour Full name of responsible person - Persian: نرگس اكرامي پور Street address - English: Shahroud - 28 m Street Street address - Persian: شاهرود- خيابان 28 متري City - English: shahroudSُُhahroud City - Persian: شاهرود Province: Semnan Country: Iran (Islamic Republic of) Postal code: 3613773955 Phone: +98 23 3236 1718 Fax: Email: delvarianzadeh_mehri@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Azad University
Name of organization / entity - Persian: دانشگاه آزاد
Full name of responsible person - English: mehri Delvarianzadeh
Full name of responsible person - Persian: مهري دلوريان زاده
Street address - English: 7 TirSQ
Street address - Persian: ميدان 7 تير
City - English: Shahroud
City - Persian: شاهرود
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3614773947
Phone: +98 23 3239 7709
Fax:
Email: delvarianzadeh_mehri@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Azad University
Name of organization / entity - Persian: دانشگاه آزاد
Full name of responsible person - English: Mehri Delvarianzadeh
Full name of responsible person - Persian: مهري دلوريان زاده
Street address - English: 7 TirSQ
Street address - Persian: ميدان 7 تير
City - English: Shahroud
City - Persian: شاهرود
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3614773947
Phone: +98 23 3239 7709
Fax:
Email: delvarianzadeh_mehri@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Azad University Name of organization / entity - Persian: دانشگاه آزاد Full name of responsible person - English: mehriMehri Delvarianzadeh Full name of responsible person - Persian: مهري دلوريان زاده Street address - English: 7 TirSQ Street address - Persian: ميدان 7 تير City - English: Shahroud City - Persian: شاهرود Province: Semnan Country: Iran (Islamic Republic of) Postal code: 3614773947 Phone: +98 23 3239 7709 Fax: Email: delvarianzadeh_mehri@yahoo.com Web page address:
Protocol summary
Study aim
The aim of this study is to determine the effects of bulk bread containing Portulaca Oleracea on lipid profile and blood sugar in patients with type 2 diabetes
Design
This study is a randomized clinical trial with parallel groups, without blinding, with 50 subjects in each group which evaluates the effect of portulaca on lipid profiles and fasting blood glucose levels in diabetic patients.
Settings and conduct
Among diabetic patients referred to diabetes clinic selected 100 patients and will be divided into two groups using quadruple blocks. The intervention group (50 patients) will receive the Portulaca Oleracea and the control group (50) will receive bulk without portulaca daily for 4 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria : age range between 30-64 years old, Body Mass Index range between 19 and 35 kg per m2, diabetic patients referring to the diabetic clinic of Shahroud (or a known diagnosis of diabetes and to diagnose a physician) fasting blood glucose ≥ 125mg / dl
Exclusion criteria: Patients receiving insulin therapy; patients with cardiovascular, renal, hepatic, hematological, hypothyroidism and convulsion diseases; patients with a history of gallstones or gallbladder surgery; patients under estrogen, steroid, beta-blocker and thiazide therapy; women planning for pregnancy; pregnant women; breast-feeding women. The use of E and C supplements of omega 3 at least 6 months before sampling, smoking and narcotics as well as those who have not been used during two weeks of training.
Intervention groups
The intervention group included 50 patients will receive bread containing portulaca ( that has already been confirmed technically by its theological, physico-chemical and Sensory properties) and the control group included 50 patients receive bulk without portulaca daily for 4 weeks.
Main outcome variables
Lipid profile and blood sugar
General information
Reason for update
1. Add the duration of the intervention
2. Add more secondary outcome measures
Acronym
IRCT registration information
IRCT registration number:IRCT20110309006010N1
Registration date:2019-05-18, 1398/02/28
Registration timing:prospective
Last update:2020-03-27, 1399/01/08
Update count:1
Registration date
2019-05-18, 1398/02/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
2220097 0273
Email address
delvarianzadeh@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-08, 1398/03/18
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of bulk bread containing Portulaca Oleracea on lipid profile and glucose level in Type II Diabetes
Public title
The effects of bread containing Portulaca Oleracea on lipid profile and blood sugar in patients with type 2 diabetes.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 30-64 years old,
Body Mass Index(BMI), range between 19 and 35 kg per m2,
Diabetic patients referring to diabetes mellitus (known as diabetes mellitus and clinician)
Fasting blood glucose ≥ 125mg / dl.
Exclusion criteria:
Patients receiving insulin therapy;
Patients with cardiovascular, renal, hepatic, hematological, hypothyroidism and convulsion diseases;
Patients with a history of gallstones or gallbladder surgery;
Patients under estrogen, steroid, beta-blocker and thiazide therapy;
Women planning for pregnancy; pregnant women; breast-feeding women.
The use of E and C supplements of omega 3 at least 6 months before sampling,
Smoking and narcotics as well as those who have not been used during two weeks of training,
Age
From 30 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After choosing patients according to inclusion and exclusion criteria and regarding the order of entry of them to this study, the envelopes in which groups A and B are selected from random numbers are opened and subjects allocated to intervention and control group.
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
Ethics Committee of Shahroud University of Medical Sciences
Street address
7th of Tir square, Tehran street, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3613773955
Approval date
2019-04-10, 1398/01/21
Ethics committee reference number
IR.SHMU.REC.1397.200
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Sugar
Timepoint
At the beginning of the study, the end of the second and fourth week
Method of measurement
Blood glucose level will be determined in laboratory by commercial standard kit
2
Description
Triglyceride
Timepoint
At the beginning of the study, the end of the second and eight week
Method of measurement
Blood triglyceride level will be determined in laboratory by commercial standard kit
3
Description
(HDL) High-density lipoprotein
Timepoint
At the beginning of the study, the end of the second and eighth week
Method of measurement
Blood HDL level will be determined in laboratory by commercial standard kit
4
Description
Low-density lipoprotein (LDL)
Timepoint
At the beginning of the study, the end of the second and fourth week
Method of measurement
Blood LDL level will be determined in laboratory by commercial standard kit
Secondary outcomes
1
Description
weight
Timepoint
At the beginning of the study, the end of the second and eighth week
Method of measurement
Scale
2
Description
Waist circumference
Timepoint
At the beginning of the study, the end of the second and eighth week
Method of measurement
Irresistible meter
3
Description
Systolic blood pressure
Timepoint
At the beginning of the study, the end of the second and eighth week
Method of measurement
Mercurial sphygmomanometer
4
Description
Diastolic blood pressure
Timepoint
At the beginning of the study, the end of the second and eighth week
At the beginning of the study, the end of the eighth week
Method of measurement
Pars Azmon Kit
Intervention groups
1
Description
"Intervention group: " included 50 patients will receive bread containing purple( that has already been confirmed technically by its theological, physico-chemical and Sensory properties) daily for 4 weeks
Category
Other
2
Description
"Control group: " included 50 patients receive bulk without purple daily for 4 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pasargad Clinic
Full name of responsible person
Narges Akramipour
Street address
Shahroud - 28 m Street
City
Sُُhahroud
Province
Semnan
Postal code
3613773955
Phone
+98 23 3236 1718
Email
delvarianzadeh_mehri@yahoo.com
2
Recruitment center
Name of recruitment center
Amam Hossian Hospital
Full name of responsible person
Fatemeh hossianpour
Street address
7 Tir SQ
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 7709
Email
delvarianzadeh_mehri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Azad University
Full name of responsible person
Mehri Delvarianzadeh
Street address
7 TirSQ
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 7709
Email
delvarianzadeh_mehri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad University
Proportion provided by this source
5
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mehri Delvarianzadeh
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
7 Tir SQ, Shahroud, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 7709
Email
delvarianzadeh@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mehri Delvarianzadeh
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
7 Tir SQ
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 7709
Email
delvarianzadeh@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mehri Delvarianzadeh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
7 Tir SQ
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 7709
Email
delvarianzadeh@shmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It has not been decided at the moment and there are no more details at the moment