Protocol summary

Summary
Type 2 diabetes is a prevalent metabolic disorder and has several complications affecting the vascular system. Broccoli sprouts rich is a source of sulforaphane with high antioxidant activity. Cell culture and animal studies showed that sulforaphane prevents diabetic vascular complications and improve lipid profile, but little is known about the direct effects of broccoli sprouts in diabetic patients. The purpose of this study is to investigate effects of broccoli sprouts powder (BSP) on fasting blood sugar, lipid profile and oxidative stress index. This study is a randomized double blind clinical trial. Fifty type2 diabetic patients will be recruited from an endocrine clinic and randomly will be assigned into 2 groups, the BSP and the placebo. Subjects in the BSP and the placebo groups will consume 10g/d BSP and corn starch powder for 4 weeks, respectively. For all subjects, medical history, 3 consecutive 24-h dietary recalls, and physical activity questionnaire will be collected and anthropometric measurements will be recorded at baseline and 4 weeks after supplementation. Also, a 14 hour overnight fasting blood sample will be taken for biochemical analysis, including fasting blood sugar, cholesterol, triglycerides, LDL-C, HDL-C, total antioxidant capacity and total oxidant status.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901181640N2
Registration date: 2010-09-02, 1389/06/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-09-02, 1389/06/11
Registrant information
Name
Parvin Mirmiran
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
mirmiran@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Obesity Research Center, Research Institute for Endocrine Science, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2010-04-30, 1389/02/10
Expected recruitment end date
2010-09-30, 1389/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Broccoli Sprouts Powder on Fasting Blood Suger, Lipid Profile and Oxidative Stress Index in Type 2 Diabetic Patients
Public title
Broccoli sprots powder and diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: •Patients suffering from NIDDM, according to present criteria for diagnosis of NIDDM. Exclusion Criteria: •Pregnant or breastfeeding women •Women of childbearing age with no safe method of contraception •Patients receiving vitamin K-antagonists, steroid hormones,antioxidant supplement •Patients with chronic liver,renal,respiratory disease •Patients with chronic or acut inflamation
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Ethics committee, Research Institute For Endocrine Sciences, Shahid Beheshti University of Medical S
Street address
#24, Parvaneh st, Yemen st, Chamran Exp
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
306EC

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
hyperglycemy,lipid profile disorder, oxidative stress
Timepoint
4 weeks
Method of measurement
biochemistry analysiss

Secondary outcomes

1

Description
decrese of blood glucose, improve lipid profile, improve oxidant/antioxidant status
Timepoint
4 weeks
Method of measurement
biochemistry analysis

Intervention groups

1

Description
broccoli sprouts powder, 10g/d
Category
Other

2

Description
corn starch powder, 10g/d
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Taleghani Hospital
Full name of responsible person
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Iran Diabetes Association
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parvin Mirmiran
Street address
Research Institute For Endocrine Sciences, #24 Parvaneh st, Yemen st, Chamran Exp
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Endocrine Sciences, Shahid Beheshti 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
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Full name of responsible person
Parvin Mirmiran
Position
Ph.D of Nutrition Sciences
Other areas of specialty/work
Street address
Research Institute For Endocrine Sciences, #24, Parvaneh st, Yemen st, Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2503
Fax
Email
mirmiran@endocrine.ac.ir , parvin.mirmiran@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Full name of responsible person
Parvin Mirmiran
Position
Ph.D of Nutrition Sciences
Other areas of specialty/work
Street address
Research Institute For Endocrine Sciences, #24, Parvaneh st, Yemen st, Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2503
Fax
Email
mirmiran@endocrine.ac.ir , parvin.mirmiran@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Full name of responsible person
Zahra Bahadoran
Position
Other areas of specialty/work
Street address
Research Institute For Endocrine Sciences, #24 Parvaneh st, Yemen st, Chamran Exp
City
Tehran
Postal code
Phone
Fax
Email
zahrabahadoran@yahoo.com , zahra.bahadoran@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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