Polyphenol compounds are found in some foods like cocoa and have beneficial effects on lipid profiles, insulin production and insulin sensitivity. 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 lipid profile and blood sugar 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 30. sample size is 30 that will be divided into two groups (dark chocolate group and the control). The period of intervention is 2 months. The primary outcomes are fasting blood sugar and lipid profiles (LDL-C, HDL-C, TG and total cholesterol).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010716123N1
Registration date:2014-06-09, 1393/03/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-06-09, 1393/03/19
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
Nutrition and Metabolic Disease Research Center, Ahvaz Jondishapur University of Medical Sciences
Expected recruitment start date
2014-10-21, 1393/07/29
Expected recruitment end date
2015-03-30, 1394/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of dark chocolate intake on serum lipid profiles, fasting blood sugar and C-reactive protein in patients with type 2 diabetes
Public title
dark chocolate effect on diabetes treatment process
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: no food supplement consumption; body mass index 18.5-29.9; 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 30); 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:
30
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
2013-10-26, 1392/08/04
Ethics committee reference number
ajums.REC.1392.157
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
fasting blood glucose
Timepoint
at the first and at the end of intervention period
Method of measurement
Autoanalyzer
2
Description
HgA1C
Timepoint
at the first and at the end of intervention period
Method of measurement
Enzymatic method
3
Description
LDL
Timepoint
at the first and at the end of intervention period
Method of measurement
Friedewald formula
4
Description
TG
Timepoint
at the first and at the end of intervention period
Method of measurement
Autoanalyzer
5
Description
HDL
Timepoint
at the first and at the end of intervention period
Method of measurement
Autoanalyzer
6
Description
hs-CRP
Timepoint
at the first and at the end of intervention period
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: diet controlling; 40 gram of 85% dark chocolate per day, for two months
Category
Treatment - Other
2
Description
control: diet controlling, for two months
Category
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 1373 8317
Fax
Email
jafarirad-s@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nutrition and Metabolic Disease Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. 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 1373 8317
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)