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The effects of dried jujube (ziziphus vulgaris) on glycemic control and lipid profile in patients with type2 diabetes

Protocol summary

Summary
This randomized controlled without placebo trial is aimed to assess the effect of dried jujube on glycemic control (fasting blood sugar, fasting Insulin,Hb A1C), lipid profile (triglyceride,total cholestrol , low-density lipoprotein, high density lipoprotein, Apo A1, Apo B100), hepatic enzymes ( alanine amino transferase, aspatate amino transferase) and hs-CRP on type 2 diabetes. 76 diabetic patients will be allocated randomly to equal groups: intervention ( using 1 serving dried jujube=28g dried jujube) and control (without using any forms of jujube during study). During study ( 3 months) participants will be asked not to change their physical activity and diet. At the beginning and ending of the study, physical activity questionnaires (IPAQ) and 24-hour dietary recall questionnaires will be completed by patients and blood pressure and anthropometric measurements included weight, hight will be measured. Too, at onset and ending of study 10 milliliter venous blood will be taken after at least 10 hours fasting to conduct the mentioned laboratory tests and at the end of the study results will be compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201604192709N37
Registration date: 2016-05-22, 1395/03/02
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-05-22, 1395/03/02
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-06-09, 1395/03/20
Expected recruitment end date
2017-03-10, 1395/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of dried jujube (ziziphus vulgaris) on glycemic control and lipid profile in patients with type2 diabetes
Public title
Effects of dried jujube on type2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:diabetic patients aged between 20-65 years; FBS more than or equal to 126 mg/dl and less than 200 mg/dl; glycosylated hemoglobin 6.5-9 percent; lack of insulin consumption; lack of history of metabolic diseases,cardiovascular disease,renal disease,tyroid ,cancer; willingness to cooperation; lack of pregnancy and lactation; no consumption of alcoholic beverages; lack of smoking; no consumption of any drug that are metabolized in P450 cytochrome. exclusion criteria:lack of willingness to continue study; Occurrence infectious disease during studys; Occurrence pregnancy during study.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
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
Iran University of Medical Sciences
Street address
Iran University of medical science,Hemmat highway,Tehran,Iran
City
Tehran
Postal code
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR.IUMS.REC.1394.9311468005

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
FBS
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Enzymatic method

2

Description
HbA1C
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Bronnate Affinity

3

Description
Insulin
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Radio Immuno Assay(RIA)

4

Description
Insulin Sensitivity
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Quantitative insulin sensitivity check index ;QUICKI

5

Description
Insulin Resistance
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Homeostasis model assessment ; HOMA

6

Description
TG
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Enzymatic method

7

Description
Total chol
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Enzymatic method

8

Description
LDL-C
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Enzymatic method

9

Description
HDL-C
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Enzymatic method

10

Description
ApoA1
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Immunoturbidimetry method

11

Description
ApoB100
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Immunoturbidimetry method

12

Description
ALT
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Enzymatic method

13

Description
AST
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Enzymatic method

14

Description
hs-CRP
Timepoint
Before intervention and 3 months after intervention
Method of measurement
ELISA test

Secondary outcomes

1

Description
Dietary intake
Timepoint
Before intervention and 3 months after intervention
Method of measurement
24-hour recall questinnaire

2

Description
Blood Pressure
Timepoint
Before intervention and 3 months after intervention
Method of measurement
digital Barometer

3

Description
Physical Activity
Timepoint
Before intervention and 3 months after intervention
Method of measurement
international physical activity questionarre

4

Description
weight
Timepoint
Before intervention and 3 months after intervention
Method of measurement
digital scale

5

Description
BMI
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Weight(kg)/(height(m))2

Intervention groups

1

Description
Intervention group: using 1 serving dried jujube=28g dried jujube daily for 3 months.
Category
Treatment - Other

2

Description
Control group: no consumption of any forms of jujube during study (3 months)
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Zahra Irannejadniri
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Street address
Iran University of Medical Sciences, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Professor
Other areas of specialty/work
Street address
Iran University of medical science,Hemmat highway,Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 8670 4711
Fax
Email
duman407@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of medical science
Full name of responsible person
Farzad Shidfar
Position
Professor
Other areas of specialty/work
Street address
Iran University of medical science,Hemmat highway,Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 8862 2755
Fax
Email
shidfar.f@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of medical science
Full name of responsible person
Farzad Shidfar
Position
professor
Other areas of specialty/work
Street address
Iran University of medical science,Hemmat highway,Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 8862 2755
Fax
Email
shidfar.f@iums.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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