Protocol summary

Summary
Metabolic syndrome is a branch of the metabolic disorders including obesity, impaired lipid metabolism, glucose intolerance, insulin resistance and hypertension that is associated with an increased risk of developing cardiovascular disease and type 2 diabetes. Recent studies show that Helicobacter pylori infection is one of the risk factors of metabolic syndrome, type 2 diabetes and cardiovascular diseases. Studies have shown that treatment of H. pylori infection in patients with metabolic syndrome cause to improvement of insulin resistance and risk factors of cardiovascular disease. This study investigated the effect of supplementation with broccoli sprouts powder as compared to standard triple therapy in patients with metabolic syndrome or type 2 diabetic patients with Helicobacter pylori infection. Stool samples are obtained to detect H. pylori stool antigen test. Patients with H. pylori infection are randomized to one of three groups, the standard triple therapy (STT), broccoli sprouts powder (BSP), or BSP+STT. STT group receive antibiotic therapy for 2 weeks. BSP group get 6 grams broccoli sprouts powder daily, and STT+BSP group receive combination of standard triple therapy and broccoli sprouts. At the beginning and one months after the treatment, stool antigen test and biochemical analysis, and urea breath test at end of the study will be performed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111081640N6
Registration date: 2011-11-27, 1390/09/06
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-11-27, 1390/09/06
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
Research Institute for Endocrine Sciences, Shahid Beheshti Medical Sciences University
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of broccoli sprouts powder supplementation on clinical and biochemical parameters in metabolic syndrome patients with positive Helicobacter Pylori test
Public title
Effects of broccoli sprouts powder supplementation on clinical and biochemical parameters in metabolic syndrome patients with positive Helicobacter Pylori test
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with metabolic syndrom according to IDF; patients with positive Helicobacter Pylori test according to stool antigene test. Exclusion criteria: pregnant or breastfeeding women; smoker or alcohol or other drugs abusers; patients receiving vitamin K antagonists, steroid hormons and antioxidant supplement. patients with diabetes,Cardiovascular ,chronic liver, respiratory, chronic renal disease; patients with chronic or acute inflamatory diseases.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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 Medical Sciences Unive
Street address
Tehran, Research Institute for Endocrine Sciences,24, Parvaneh St,Chamran Exxp,Tehran
City
Tehran
Postal code
Approval date
2011-08-02, 1390/05/11
Ethics committee reference number
357EC

Health conditions studied

1

Description of health condition studied
metabolic syndrom
ICD-10 code
ٍE90
ICD-10 code description
Nutritional and metabolic disorders in diseases classified elsewhere

Primary outcomes

1

Description
Decrease of H.Pylori infection
Timepoint
6 weeks
Method of measurement
Biochemical analysis

2

Description
Improvement of metabolic syndrome risk factors
Timepoint
6 weeks
Method of measurement
Biochemical analysis

3

Description
Improvement of oxidative stress
Timepoint
6 weeks
Method of measurement
Biochemical analysis

Secondary outcomes

1

Description
Improvement of metabolic syndrom criteria
Timepoint
6 weeks
Method of measurement
Biochemical analysis

2

Description
Improvement of metabolic syndrom criteria
Timepoint
6 weeks
Method of measurement
biochemical analysis

Intervention groups

1

Description
-broccoli sprouts powder 6 g/day
Category
Placebo

2

Description
corn starch 6 g/day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Institute for Endocrine Sciences, Shahid Beheshti Medical Sciences University
Full name of responsible person
Pavin Mirmiran
Street address
Tehran, Research Institute for Endocrine Sciences, 24 Parvaneh St, Yaman St, Chamran Exp
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti Medical Sciences University
Full name of responsible person
Parvin Mirmiran
Street address
Tehran, Research Institute for Endocrine Sciences, 24 Parvaneh St, Yaman 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 Medical Sciences University
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
Research Institute for Endocrine Sciences, Shahid Beheshti Medical Sciences University
Full name of responsible person
Parvin Mirmiran
Position
Ph.D of Nutrition Sciences-
Other areas of specialty/work
Street address
Tehran, Research Institute for Endocrine Sciences, 24 Parvaneh St, Yaman St, Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2503
Fax
Email
mirmiran@endocrine.ac.ir
Web page address

Person responsible for scientific inquiries

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

Person responsible for updating data

Contact
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti Medical Sciences University
Full name of responsible person
Zahra Bahadoran
Position
Msc student of Nutrition Sciences
Other areas of specialty/work
Street address
Tehran, Research Institute for Endocrine Sciences, 24 Parvaneh St, Yaman St, Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2503
Fax
Email
mirmiran@endocrine.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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