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The effect of Anethum graveolens supplementation on some blood biochemical parameters in type 2 Diabetes Patients

Protocol summary

Summary
This study is a randomized double-blind placebo controlled trial that will carry on 60 diabetic patients according to specialist diagnosis from clinics of Tabriz University of Medical Science. The aim of the study is to evaluate the effect of Anethum graveolens supplementation on some blood biochemical parameters in type 2 Diabetes Mellitus patients. Patients will be divided randomly to 2 groups; intervention group : patients recieve3 pill containing 1g powder of anethum herb, and placebo group patients take 3 pill containing 1g isomalt capsule for 60 days. Anthropometric measurements (weight, height, waist and hip circumference), biochemical criteria including lipid profile (TG,TC,HDL-C,LDL-C), inflammation markers (hs-CRP, IL-6, TNF-a) , blood glucose and serum antioxidants using 5cc blood collected, physical activity levels and dietary record will be measured before and after treatment (8 week).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112312017N6
Registration date: 2012-01-10, 1390/10/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-01-10, 1390/10/20
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Tabriz University Of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Anethum graveolens supplementation on some blood biochemical parameters in type 2 Diabetes Patients
Public title
The effect of Anethum graveolens supplementation on some blood biochemical parameters in type 2 Diabetes Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-65 years; proven diagnosis for diabetes mellitus; absence of antioxidants supplementation in previous months or in the study and absence of special diet. Exclusion criteria: history of impaired immune system; alcohol use and depression.
Age
From 18 years old to 65 years old
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-chancellor for research-Tabriz University of Medical Science
Street address
Golgasht street, Tabriz, East Azarbayjan,Iran, Islamic Republic Of
City
Tabriz
Postal code
Approval date
2011-10-23, 1390/08/01
Ethics committee reference number
5.4.5842

Health conditions studied

1

Description of health condition studied
Diabetes type2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Lipid profiles (TC, TG, LDL-C, HDL-C)
Timepoint
Baseline and at the end of intervention
Method of measurement
Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5)

2

Description
Inflammation markers (hs-CRP ، TNF-α،IL-6)
Timepoint
Baseline and at the end of intervention
Method of measurement
ELISA

3

Description
Blood glucose
Timepoint
Baseline and at the end of intervention
Method of measurement
Enzymatic method

Secondary outcomes

1

Description
Serum Antioxidant
Timepoint
Baseline and at the end of intervention
Method of measurement
enzymatic method

2

Description
Nutritional status
Timepoint
Baseline and at the end of intervention
Method of measurement
Dietary record and food frequency questionnaire

3

Description
Anthropometric measurements
Timepoint
Baseline and at the end of intervention
Method of measurement
Analogue scale and meter

Intervention groups

1

Description
Intervention group: daily 3 pill of containing 1g powder of Anethum herb for 60 day
Category
Treatment - Drugs

2

Description
Placebo group: 3 pill containing 1g powder of isomalt for 60 day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences Clinics
Full name of responsible person
Laleh Payahoo
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz , East Azarbayjan ,Iran, Islamic Republic Of
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Tabriz University Of Medical Sciences, Tabriz, East Azarbaijan, Iran
City
Tabriz
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 Tabriz 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
Tabriz university of medical science
Full name of responsible person
Laleh Payahoo
Position
MSc student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz East Azarbayjan Iran, Islamic Republic Of
City
Tabriz
Postal code
Phone
+98 41 1335 2295
Fax
Email
llllpayahoo44@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz university of medical science
Full name of responsible person
Alireza Ostadrahimi
Position
Assistant professor in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz, East Azarbayjan, Iran, Islamic Republic Of
City
Tabriz
Postal code
Phone
+98 41 1335 2295
Fax
Email
ostadrahimi@tbzmed.ac.ir llllpayahoo44@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Laleh Payahoo
Position
MSc student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz East Azarbayjan Iran, Islamic Republic Of
City
Tabriz
Postal code
Phone
+98 41 1335 2295
Fax
Email
ostadrahimi@tbzmed.ac.ir llllpayahoo44@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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