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Comparing the effects of substitution of red meat with soybeans and non- soy Legumes on the glycemic control, lipid profile, inflammatory markers and oxidative stress in adults with type 2 diabetes

Protocol summary

Summary
Objectives: The present study is a parallel, randomized trial to compare the effects of substitution of red meat with soybeans and non- soy legumes on the glycemic control, lipid profile, inflammatory markers and oxidative stress in 60 adults with type 2 diabetes for 8 weeks. Participants: Inclusion criteria are type II diabetes for at least 6 months and aged between 40 and 65 years and exclusion criteria are the use of insulin, ثxistence thyroid disorders, gastrointestinal disorders such as bloat, kidney, liver and cardiovascular diseases and a history of allergy to soybeans or legumes. Design and setting and conduct: After obtaining written informed consent of patients, divided into three groups of 20 persons by randomized block design. Intervention: from 4 weeks before intervention in the control group (use of two servings of red meat for three days a week) and two intervention groups (consumption two servings of soy bean and legume for three days a week) use of lipid-lowering drugs be discontinued under medical supervision. Main outcome measures: At the beginning and end of the intervention measurement of height, weight, waist circumference, systolic and diastolic blood pressure, blood glycemic control, lipid profile, inflammatory markers and oxidative stress (By 5 ml fasting blood sample), taking 3-days food record and physical activity will be doing.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112925276N1
Registration date: 2016-04-26, 1395/02/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-26, 1395/02/07
Registrant information
Name
Zeinab Hematdar
Name of organization / entity
Shiraz Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 936 594 0281
Email address
stud2560183072@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-01-06, 1394/10/16
Expected recruitment end date
2016-03-21, 1395/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of substitution of red meat with soybeans and non- soy Legumes on the glycemic control, lipid profile, inflammatory markers and oxidative stress in adults with type 2 diabetes
Public title
the effects of substitution of red meat with soybeans and non- soy Legumes on diabet improvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having Type II diabetes for at least 6 months/ age between 40 to 65 years/ People with medium and high socio-economic status (with the ability to buy meat, beans or soybeans) Exclusion Criteria: The need to use insulin/ The need to take cholesterol-lowering drugs/ thyroid disorders, gastrointestinal disorders such as bloat, kidney , liver and cardiovascular diseases/ Participate in other studies in the past 6 months/ allergies to soy or bean/ The use of corticosteroids, cyclosporine and warfarin, NSAIDs and immunosuppressive/ Smoking/ Consume Alcohol/ pregnancy or breast-feeding/ history of ovarian cysts
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All patients are assigned to one of three groups by blocked randomizasion: control groups (red meat) and experimental groups (soybeans and legumes) .

Secondary Ids

1

Registry name
Shiraz University of Medical Sciences
Secondary trial Id
IRCT25276N1
Registration date
1394-10-20, 777/01/-1246

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Street, Medical University Bildings
City
Shiraz
Postal code
14336 - 71348
Approval date
2015-12-31, 1394/10/10
Ethics committee reference number
IR.SUMS.REC.1394.144

Health conditions studied

1

Description of health condition studied
Non-insulin dependent diabetic patients
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
before and after intervention
Method of measurement
blood test

Secondary outcomes

1

Description
Hb A1C
Timepoint
before and after intervention
Method of measurement
blood test

2

Description
Serum insulin
Timepoint
before and after intervention
Method of measurement
blood test

3

Description
triglyceride
Timepoint
before and after intervention
Method of measurement
blood test

4

Description
Total cholesterol
Timepoint
before and after intervention
Method of measurement
blood test

5

Description
HDL cholesterol
Timepoint
before and after intervention
Method of measurement
blood test

6

Description
LDL cholesterol
Timepoint
before and after intervention
Method of measurement
blood test

7

Description
Malondialdehyde
Timepoint
before and after intervention
Method of measurement
blood test

8

Description
CRP
Timepoint
before and after intervention
Method of measurement
blood test

9

Description
blood pressure
Timepoint
Before the intervention, 4 weeks after the intervention, after intervention
Method of measurement
Mercury sphygmomanometer

10

Description
weight
Timepoint
Before the intervention, 4 weeks after the intervention, after intervention
Method of measurement
Digital scale

11

Description
Waist circumference
Timepoint
Before the intervention, 4 weeks after the intervention, after intervention
Method of measurement
meter

Intervention groups

1

Description
Case 1: Taking a cup of cooked soy beans three days a week and avoiding the use of beans and red meat during the study for 8 weeks
Category
Treatment - Other

2

Description
Case 2: Taking a cup of cooked beans three days a week and avoiding the use of soy bean and red meat during the study for 8 weeks
Category
Treatment - Other

3

Description
control: Taking two units of red meat three days a week and avoiding the use of beans and soy beans during the study for 8 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari clinic
Full name of responsible person
zeinab hematdar
Street address
Fars, Shiraz, Namazi, Karim Khan Zand Blvd
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Doctor Seyyed Basir Hashemi
Street address
Madical University of Bildings, Zand Street
City
Shiraz
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 of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
zeinab hematdar
Position
MSc student at Shiraz university of medical sciences
Other areas of specialty/work
Street address
Razi Blvd, College of Boulevard secret, Faculty of Nutrition and Food Science
City
Shiraz
Postal code
Phone
+98 717251001
Fax
Email
zhemmatdar@gmail.comhemmatdar_z@yahoo.comstud2560183072@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
zeinab hematdar
Position
MSc student at Shiraz university of medical sciences
Other areas of specialty/work
Street address
Razi Blvd, College of Boulevard secret, Faculty of Nutrition and Food Science
City
Shiraz
Postal code
Phone
+98 717251001
Fax
Email
zhemmatdar@gmail.comhemmatdar_z@yahoo.comstud2560183072@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
zeinab hematdar
Position
MSc student at Shiraz university of medical sciences
Other areas of specialty/work
Street address
Razi Blvd, College of Boulevard secret, Faculty of Nutrition and Food Science
City
Shiraz
Postal code
Phone
+98 717251001
Fax
Email
zhemmatdar@gmail.comhemmatdar_z@yahoo.comstud2560183072@sums.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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