The effect of dark chocolate intake on serum nitric oxide, angiotensin∏ , adiponectin, inflammatory cytokines (IL-6، TNFα) and blood pressure in patients with type 2 diabetes.
Polyphenol compounds are found in some foods like cocoa and have beneficial effects on inflammatory factors. According to that appropriate diet are very important in diabetics patients, so it is important to consume some foods that could be effective on treatment and reduction of diabetes complications.This study was designed to investigate the effect of dark chocolate (that contains many polyphenols) on serum nitric oxide, angiotensin∏, adiponectin, inflammatory cytokines and blood pressure in diabetic patients. The study people are patients with type 2 diabetes. Inclusion criteria are 30-60 years old type 2 diabetic patients with no other diseases and the key exclusion criteria is BMI more than 35. sample size is 50 that will be divided into two groups (dark chocolate group and the control). The period of intervention is 2 months. The primary outcomes are nitric oxide angiotensin∏, adiponectin, inflammatory cytokines (IL-6, TNFα) and blood pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015022116123N5
Registration date:2015-03-11, 1393/12/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-11, 1393/12/20
Registrant information
Name
Sima Jafarirad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8317
Email address
jafarirad-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dark chocolate intake on serum nitric oxide, angiotensin∏ , adiponectin, inflammatory cytokines (IL-6، TNFα) and blood pressure in patients with type 2 diabetes.
Public title
dark chocolate effect on cardiovascular side effect of diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: no food supplement consumption; body mass index 18.5-34.9; 30-60 years old; using only blood glucose reducing drugs, Metformin and Glibenclamide; willing to participate. Exclusion criteria: no appropriate corporation; any other disease; Obesity∏ (body mass index more than 34.9); pregnancy and lactating.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Scineces
Street address
The Ethics Committee, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, University City, Golestan Blvd.
City
Ahvaz
Postal code
Approval date
2015-01-31, 1393/11/11
Ethics committee reference number
ajums.REC.1393.407
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
nitric oxide
Timepoint
at the first and at the end of intervention period
Method of measurement
ELISA
2
Description
adiponectin
Timepoint
at the first and at the end of intervention period
Method of measurement
ELISA
3
Description
angiotensin∏
Timepoint
at the first and at the end of intervention period
Method of measurement
ELISA
4
Description
Interleukine- 6
Timepoint
at the first and at the end of intervention period
Method of measurement
ELISA
5
Description
Tumor necrosis Factor-α
Timepoint
at the first and at the end of intervention period
Method of measurement
ELISA
6
Description
blood pressure
Timepoint
at the first and at the end of intervention period
Method of measurement
Mercury sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: diet controlling; 30 gram of 84% dark chocolate per day, for two months
Category
Treatment - Other
2
Description
control: diet controlling, for two months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Jafarirad
Street address
Golestan Hospital, Farvardin Street, Golestan
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology
Street address
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, University City, Golestan Blvd.
City
Ahvaz
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 and Technology, Ahvaz Jundishapur 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition and Metabolic Disease Research Center, Ahvaz Jundishapur University of Medical Sciences, A
Full name of responsible person
Dr. Sima Jafarirad
Position
PhD
Other areas of specialty/work
Street address
Nutrition and Metabolic Disease Research Center, Ahvaz Jundishapur University of Medical Sciences, University City, Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 61 3373 8317
Fax
Email
jafarirad-s@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, paramedics schools
Full name of responsible person
nina ayoobi
Position
master student of nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Golestan Blvd, paramedics schools
City
Ahvaz
Postal code
Phone
00
Fax
Email
n.ayoobi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)