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Effects of Soy nut Supplementation on Glycemic Control, Lipid Profile and Insulin Resistance in Type 2 Diabetic Subjects

Protocol summary

Summary
This study is a prospective and randomized single-blind clinical trial. The aim of this study is effects of soy nut supplementation on glycemic control, lipid profile and insulin resistance in type 2 diabetic subjects. Total of sample size is 70 patient with ages: 30-70 years old. The patients with liver failure, renal failure, heart failure, using insulin, allergy to soy and if patients do not use soy nuts more than five days continuous or ten days discontinuous will be excluded. The patients are randomly divided into two groups. Patients do not know about the protocol of the study. First group receives 60 gram package of Soy nuts without salt, Daily in the morning and the evening for 8 weeks. The second group as a control group does not receive anything. Both groups are matched in terms of taking energy, protein, fat and carbohydrates. Patients basic information such as age and sex, Stature, BMI, serum triglyceride, LDL, HDL, total cholesterol, fasting blood sugar, fasting insulin levels, hemoglobin A1c (HbA1c) will be recorded in both groups before Intervention and after the Intervention period. During the study, both groups are placed under therapeutic life style changes diet and dietary recommendations for diabetes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014022616755N1
Registration date: 2015-11-14, 1394/08/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-11-14, 1394/08/23
Registrant information
Name
Alireza Sedaghat
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
sedaghat.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-05-10, 1393/02/20
Expected recruitment end date
2014-06-10, 1393/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Soy nut Supplementation on Glycemic Control, Lipid Profile and Insulin Resistance in Type 2 Diabetic Subjects
Public title
Effects of Soy Nut Supplementation on Glycemic Control and Llipid Profile in Diabetic Subjects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with type 2 diabetes; Patients with ages: 30-70 years old; BMI less than 35; FBS less than 250; HbA1c less than 8.5. Exclusion Criteria: Patients with liver failure; Renal failure; Heart failure; Using insulin; Allergy to soy nut.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
To randomization: Consecutive odd and even numbers are assigned to patients. 60 gram package of Soy nuts daily for 8 weeks are administered to odd and even numbered as a control group does not receive anything.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2014-01-04, 1392/10/14
Ethics committee reference number
ajums.REC.1392.258

Health conditions studied

1

Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Fasting blood glucose levels (FBS)
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

2

Description
Hemoglobin A1c (HbA1c) levels
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

3

Description
The serum levels of triglycerides, LDL, HDL, Total cholesterol
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

4

Description
Fasting insulin levels
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

5

Description
insulin resistance
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
By Using the homeostasis model Assessment-insulin resistance (HOMA-ir) formula: fasting glucose (mmol/L) × fasting insulin (μU/ml)/22.5

Secondary outcomes

1

Description
Body mass index (BMI)
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Kg/m2 (Body weight to square of length ratio)

2

Description
Systolic blood pressure
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
mmHg, with manometer in sitting state from right arm

3

Description
Diastolic blood pressure
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
mmHg, with manometer in sitting state from right arm

Intervention groups

1

Description
Group I: Prescription 60 gram package of Soy nuts without salt, Daily in the morning and the evening for 8 weeks.
Category
Other

2

Description
Group II: The second group as a control group does not receive anything.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Fatemeh Heidari
Street address
Golestan Hospital, Farvardin st., Golestan, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
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 Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Alireza Sedaghat
Position
fellowship in endocrinology and metabolic diseases
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
Alireza_sedaghat51@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hajieh Shahbazian
Position
Subspecialty Endocrinology and Metabolism
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
Hjb_shahbazian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sanaz Nazari
Position
Nurse Anesthesia
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
Fax
Email
s.nz1990@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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