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Effects of dried Zizyphus Vulgaris fruit on lipid profile, blood sugar indices and some inflammatory factors in non insulin dependent diabetes melitus patients

Protocol summary

Summary
This randomized controlled without placebo trial is aimed to assess the effectiveness of dried fruit of ziziphus vulgaris on sugar indices and lipid profile and some inflammation factors on 30 diabetic type 2 patients that are allocated randomly to control(15) and intervention(15) groups. to assess the received nutritional materials,dietary data is completed and compared for 2 days before intervention and 2 days before ending of intervention. then questionnaire of demographic factors and nutritional habits is completed and weight and height are measured. fasting blood sugar, fasting insulin ,blood sugar 2 hours after eating food , total cholesterol, low density lipo-protein cholesterol, high density lipo-protein cholesterol, triglyceride, aspartame amino transferase ,alanine amino transferase, interleukin 6, Blood urea nitrogen, Creatinin are measured in reference laboratory after 10 hours fasting.Then participants of intervention group,addition to routine treatment, will receive packages including 15 gram powder of dried ziziphus vulgaris fruit to be eaten twice daily 30 minutes before lunch and dinner each time 15 gram for 90 days. The control group will receive only routine treatment.After 3 months intervention, the variables are measured again to be compared in the intervention and control groups. At onset and ending of study ,10 milliliter venous blood is taken after at least 10 hours fasting to conduct the laboratory tests

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201506192531N3
Registration date: 2015-07-08, 1394/04/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-07-08, 1394/04/17
Registrant information
Name
Tahmineh Dadkhahtehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7596
Email address
dadkhah-tehrani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Qom University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of dried Zizyphus Vulgaris fruit on lipid profile, blood sugar indices and some inflammatory factors in non insulin dependent diabetes melitus patients
Public title
Effects of dried Zizyphus Vulgaris fruit on lipid profile, blood sugar indices and some inflammatory factors in non insulin dependent diabetes melitus patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:History of more than 2 years NIDDM; regular reference to physician for follow up Exclusion criteria:Having diseases of kidney or liver; pregnancy; cigarette consumption;being alcoholic; insulin consumption; being exposure to sever stress during study (infection, diabetic foot,surgery, serious psychological stress ); depression; consumption of psychotropic drug; experience of embarrassing complications due to ziziphus consumption; irregular consumption of ziziphus; applying other complementary treatment method simultaneously during study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done via simple lottery method

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
Research Chancellor for research of Qom University of Medical Sciences,N 83, Alley 1/1, Alley 4, Safashahr street, Qom
City
Qom
Postal code
37169-87366
Approval date
2015-06-11, 1394/03/21
Ethics committee reference number
IR.MUQ.REC.1394.40

Health conditions studied

1

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

Primary outcomes

1

Description
fasting blood sugar
Timepoint
before intervention and after 3 months intervention
Method of measurement
milligram per deciliter

2

Description
total cholestrol
Timepoint
before intervention and after 3 months intervention
Method of measurement
milligram per deciliter

Secondary outcomes

1

Description
low density lipo protein to high density lipo protein ratio
Timepoint
before intervention and after 3 months intervention
Method of measurement
numerical ratio

2

Description
interlukine 6
Timepoint
before intervention and after 3 months intervention
Method of measurement
picogram per deciliter

3

Description
blood sugar 2 hours after food
Timepoint
before intervention and after 3 months intervention
Method of measurement
milligram per deciliter

4

Description
body mass index
Timepoint
before and after 3 months intervention
Method of measurement
numeral ratio

5

Description
fasting insuline
Timepoint
before intervention and after 3 months intervention
Method of measurement
micro unit per milliliter

6

Description
hemoglobin A1c
Timepoint
before intervention and after 3 months intervention
Method of measurement
percent

7

Description
high density lipoprotein-cholestrol
Timepoint
before intervention and after 3 months intervention
Method of measurement
milligram per deciliter

8

Description
low density lipoprotein-cholestrol
Timepoint
before intervention and after 3 months intervention
Method of measurement
milligram per deciliter

9

Description
trigeliceride
Timepoint
before intervention and after 3 months intervention
Method of measurement
milligram per deciliter

10

Description
Alanine Aminotransferase
Timepoint
before intervention and after 3 months intervention
Method of measurement
unit per liter

11

Description
Aspartate Aminotransferase
Timepoint
before intervention and after 3 months intervention
Method of measurement
unit per liter

12

Description
Erythrocyte sedimentation rate
Timepoint
before intervention and after 3 months intervention
Method of measurement
millimeter per hour

13

Description
c reactive protein
Timepoint
before intervention and after 3 months intervention
Method of measurement
milligram per liter

14

Description
blood urea nitrogen
Timepoint
before intervention and after 3 months intervention
Method of measurement
milligram per deciliter

15

Description
Creatinine
Timepoint
before intervention and after 3 months intervention
Method of measurement
milligram per deciliter

16

Description
Quality of Sleep
Timepoint
before and after 3 months intervantion
Method of measurement
Pittsburgh Sleep Quality Index

Intervention groups

1

Description
Intervention group will eat 15 gram of powder of dried ziziphus fruit(total 30 gram per day) 30 minutes before lunch and dinner as they wish (for example mixed in water ) for 90 days.
Category
Treatment - Other

2

Description
Control group will receive no additional intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized clinic of Shahid Beheshti hospital of Qom
Full name of responsible person
Doctor Mahmood Parham
Street address
Shahid Beheshti hospital, Shahid Beheshti boulvard, Qom
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Qom University of Medical Sciences
Full name of responsible person
Mohammad Hosein Abdolmohammadi
Street address
N 83, Research deputy of Qom University of Medical Sciences, Alley 1/1, Alley 4, Safashahr street, Qom
City
Qom
Grant name
Grant code / Reference number
94539
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Qom 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
Qom University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhah Tehrani
Position
Academic member/ MS Degree
Other areas of specialty/work
Street address
Qom University of Medical Sciences, Shahid Lavasani street, Qom
City
Qom
Postal code
3713649367
Phone
+98 25 3770 3736
Fax
Email
tdtahmineh@gmail.com ; dadkhah-tehrani@muq.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhah Tehrani
Position
Ms degree in midwifery
Other areas of specialty/work
Street address
Qom University of Medical Sciences, Shahid Lavasani street, Qom
City
Qom
Postal code
3713649367
Phone
+98 25 3770 3736
Fax
Email
tdtahmineh@gmail.com; dadkhah-tehrani@muq.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhah Tehrani
Position
Academic member/ MS Degree
Other areas of specialty/work
Street address
Qom University of Medical Sciences, Shahid Lavasani street, Qom
City
Qom
Postal code
3713649367
Phone
+98 25 3770 3736
Fax
Email
tdtahmineh@gmail.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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