Broccoli sprouts have shown beneficial effects on pathological conditions such as cadiovascular diseases. In the present study we aimed to examine the effect of consumption of broccoli sprouts on pro-inflammatory and anti-inflammatory markers in patients with type 2 diabetes. Eighty patients (40 in each group) with type 2 diabetes will be recruited and randomly divided into two groups. Blood samples and 24-h dietary recall will be taken before intervention. Then, for two months participants in one group will receive 10 mg dried broccoli sprouts per day, and another group will receive the same amount of corn starch as placebo. At the end of the intervention, blood samples will be taken, serum will be separated and examined for detection of C-reactive protein, tumor necrosis alpha, and interleukin-6. Data will be analyzed with SPSS version 16.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070810190N4
Registration date:2013-07-17, 1392/04/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-17, 1392/04/26
Registrant information
Name
Masoumeh Akhlaghi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 7288
Email address
akhlaghi_m@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-01-31, 1392/11/11
Expected recruitment end date
2014-09-30, 1393/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the effect of broccoli sprouts on pro- and anti- inflammatory markers in serum of patients with type 2 diabetes
Public title
Determination of the effect of broccoli sprouts on inflammation in patients with diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Patients with type 2 diabetes with at least 3 years from the onset of the disease.
Exclusion: Insulin therapy, taking especial medications such as hormones, hypoglycemic agents, and lipid lowering medications, vitamin and iron supplements, vitamin K antagonists, those with nephropathy, neuropathy, and cardiovascular disease, liver disease, cancers, autoimmune and inflammatory diseases, pregnant and lactating women, smokers, and those on especial diets, and those who make major changes in their diet during intervention.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Blvd
City
Shiraz
Postal code
Approval date
2012-09-06, 1391/06/16
Ethics committee reference number
CT-91-6224
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
C reactive protein
Timepoint
At the beginning of study and at the end of intervention
Method of measurement
Biochemical analysis
2
Description
Tumor necrosis factor-alpha
Timepoint
At the beginning of study and at the end of intervention
Method of measurement
Biochemical analysis
3
Description
Interleukin-6
Timepoint
At the beginning of study and at the end of intervention
Method of measurement
Biochemical analysis
Secondary outcomes
1
Description
Body mass index
Timepoint
At the beginning and at the end of study
Method of measurement
Weighing
Intervention groups
1
Description
10 g per day dried broccoli sprouts. Broccoli sprouts are an agricultural product cultivated by Agriculture Division in Shiraz University. Sprouts are consumed once per day for two months. Participants are asked to consume the sprouts with yogurt or other dishes.
Category
Treatment - Drugs
2
Description
10 g/day corn starch colored with spinach powder. Participants are asked to consume the starch with yogurt or other dishes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Physicians' offices
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Hatam
Street address
Central Building-Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Akhlaghi
Position
Assistant professor
Other areas of specialty/work
Street address
Razi Blvd, College of Health and Nutrition
City
Shiraz
Postal code
Phone
+98 71 1725 7288
Fax
Email
akhlaghi_m@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Akhlaghi
Position
Assistant professor
Other areas of specialty/work
Street address
Razi Blvd, College of Health and Nutrition
City
Shiraz
Postal code
Phone
+98 71 1725 7288
Fax
Email
akhlaghi_m@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Akhlaghi
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Health and Nutrition- Razi Blvd
City
Shiraz
Postal code
Phone
+98 71 1725 7288
Fax
Email
akhlaghi_m@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)