Evaluation of the effect of chocolate consumption on oxidative stress conditions, glucose and lipid profile and insulin resistance in patients with metabolic syndrome
This study is a blind clinical trial. the aim of this study is to determine the effects of dark chocolate consumption on antioxidant status, serum glucose, lipid profile and insulin resistance in patients with metabolic syndrome. 114 patients 30-60 years of age with diagnosed metabolic syndrome that had been detected by khatamolanbia Center, After filling out the consent, will be recruited to the study. Period of intervention is 8 weeks. According to random assignment, patients will be divided into three groups: 1) 20g/d dark chocolate consumption , or 2) 40 gr/day dark chocolate consumption, or 3) control group that receives no intervention. Anthropometric and biochemical measurements, medical and general information and 24-hour dietary recalls will be collected at the beginning and the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022812122N2
Registration date:2013-04-28, 1392/02/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-28, 1392/02/08
Registrant information
Name
Faezeh Poursoleiman
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1623 4120
Email address
f.poursoleiman@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoughi University of Medical Sciences.
Expected recruitment start date
2013-05-05, 1392/02/15
Expected recruitment end date
2013-09-06, 1392/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of chocolate consumption on oxidative stress conditions, glucose and lipid profile and insulin resistance in patients with metabolic syndrome
Public title
effect of dark chocolate consumption on metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
diagnosed metabolic syndrome based on NCEP definition by speceialist and age of 30 to 60 years; without any kidney, liver, heart, stomach,thyroid disease, anemia and Fibrocystic breast; not taking vitamin and antioxidant supplements in recent months; not pregnant or lactating.
exclusion criteria: taking less than 80% of given chocolates; changing the type and dose of routine medicine.
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:
114
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
Department of Research and technology, Shahid Sadoughi University
Street address
University Department, Bahonar squareو غشظی
City
Yazd
Postal code
Approval date
2013-02-24, 1391/12/06
Ethics committee reference number
172757/1/17/ب
Health conditions studied
1
Description of health condition studied
metabolic syndrome
ICD-10 code
Z86.3
ICD-10 code description
Personal history of endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
oxidative stress condition
Timepoint
Before and after intervention
Method of measurement
measurement of plasma free radical trapping capacity ,and serum MDA
2
Description
Fasting Blood Sugar
Timepoint
Before and after intervention
Method of measurement
enzymatic
3
Description
insulin resistance
Timepoint
Before and after intervention
Method of measurement
HOMA calculation
4
Description
serum triglyceride
Timepoint
Before and after intervention
Method of measurement
enzymatic
5
Description
total cholesterol
Timepoint
Before and after intervention
Method of measurement
enzymatic
6
Description
High density Lipoprotein (HDL)
Timepoint
Before and after intervention
Method of measurement
enzymatic
7
Description
low density Lipoprotein (lDL)
Timepoint
Before and after intervention
Method of measurement
freidewald formula
Secondary outcomes
empty
Intervention groups
1
Description
intervension group 1= two times Dark chocklate consumption per day, each time 10gr
Category
Treatment - Other
2
Description
control group= recieve no intervension
Category
Treatment - Other
3
Description
intervension group2= 2 times dark chocklate per day, each time 20gr
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Dr Hasan Mozaffari Khosravi
Street address
Diabetes Center, Afshar hospital, Jomhuri Blvd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Hasan Mozaffari Khosravi
Street address
Department of Health, Imam Reza building, Student Blvd, Imam Hossein Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahid Sadoughi 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
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Akram Naghdipour
Position
Student of MSc Health Sciences in Nutrition
Other areas of specialty/work
Street address
Graduate Units, Department of Health, Imam Reza building, Student Blvd, Imam Hossein Square
City
Yazd
Postal code
Phone
+98 35 1623 4120
Fax
Email
naghdipour86@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadughi University of Medical Sciences
Full name of responsible person
Dr Hasan Mozaffari Khosravi
Position
PhD in Nutritional Sciences
Other areas of specialty/work
Street address
Department of Health, Imam Reza building, Student Blvd, Imam Hossein Square
City
Yazd
Postal code
Phone
+98 35 1724 0173
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Shahid Sadughi University of Medical Sciences
Full name of responsible person
Akram Naghdipour
Position
Student of MSc Health Sciences in Nutrition
Other areas of specialty/work
Street address
Department of Health, Imam Reza building, Student Blvd, Imam Hossein Square
City
Yazd
Postal code
Phone
+98 35 1623 4120
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)