Comparison of the effect of whole wheat and white bread on Serum Lipid profile, Malondialdehyde, and C_reactive protein in over weight and obese patients with coronary stent
We aim to examine the effect of whole wheat VS. white bread on serum lipid profiles, Malondialdehyde; and C_reactive protein in overweight and obese patients with Coronary stent. Eighty men and women who had stent and BMI ≥ 25 by using block randomization were be divided into two groups. Intervention group consumed 150 g of whole-wheat bread daily accompanied with a low-calorie diet and the Control group consumed 150 g of white-wheat bread as well as a low-calorie diet. The intervention was continued for 3 months. All groups were advised not to change their physical activity during the study. Primary outcome (BMI, lipid profile, MDA, hs_CRP, blood pressure, waist and hip circumference) were evaluated at baseline and end of the study. Data will be analysis with SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021021039N1
Registration date:2015-08-16, 1394/05/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-16, 1394/05/25
Registrant information
Name
Razieh Khorramnazari
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
khoramnazari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2015-02-10, 1393/11/21
Expected recruitment end date
2015-07-12, 1394/04/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of whole wheat and white bread on Serum Lipid profile, Malondialdehyde, and C_reactive protein in over weight and obese patients with coronary stent
Public title
Effect of Whole bread on patients with Coronary diseases
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate, having stent for Atherosclerosis, Body Mass Index ≥ 25, whole grain product consumption ≤ 3 servings/d, not having any kidney, liver or thyroid diseases, nonsmoker, pregnant or lactating.
Exclusion criteria: poor participation, lack of adherence to the study protocol
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics committee of Shiraz University of Medical Sciences
Street address
7th floor, Shiraz University main Office, Zand St.
City
Shiraz
Postal code
Approval date
2015-02-03, 1393/11/14
Ethics committee reference number
CT- 9372-7342
Health conditions studied
1
Description of health condition studied
Patients with Coronary stent
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Lipid profile
Timepoint
At the beginning and end of the intervention
Method of measurement
By use of bt1500 set and Pars test kit
2
Description
hs_CRP
Timepoint
At the beginning and end of the intervention
Method of measurement
ELISA
3
Description
MDA
Timepoint
At the beginning and end of the intervention
Method of measurement
Spectroscopy and photometric method
4
Description
Blood Pressure
Timepoint
At the beginning and end of the intervention
Method of measurement
mmHg-piezometer
5
Description
Body Mass Index
Timepoint
At the beginning and end of the intervention
Method of measurement
BMI will be calculated as weight (kg)/ height (m)2
6
Description
Waist circumference
Timepoint
At the beginning and end of the intervention
Method of measurement
Tape measure
7
Description
Hip circumference
Timepoint
At the beginning and end of the intervention
Method of measurement
Tape measure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group consumed 150 g of whole-wheat bread daily as well as a low-calorie diet. Patients consumed 90 g of whole wheat bread for breakfast and 60 g at dinner. The intervention continued for 3 months. Bread was given to the participants weekly. The breads is produced by Hadith Factory in Shiraz. (Health produce ministry.: 36/12435, Lic No.: 817072, Health benefit ministry No.: 9137)
Category
Prevention
2
Description
Control group consumed 150 g of white_wheat_bread daily as well as a low-calorie diet. Patients consumed 90 g of the bread at breakfast and 60 g for dinner. The intervention continued for 3 months.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Clinic
Full name of responsible person
Razieh Khorramnazari
Street address
Namazi Square, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor off Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyyed Basir Hashemi
Street address
7th floor, Shiraz University main Office, Zand St.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor off Research, 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
School of Nutrition and Food Science
Full name of responsible person
Razieh Khorramnazari
Position
MS Candidate of Nutrition
Other areas of specialty/work
Street address
School of Nutrition and Food Science. Across from Bargh Stadium, Razi Blvd.
City
Shiraz
Postal code
Phone
0098 71_372_51001
Fax
Email
khoramnazari@sums.ac.ir rkhoramnazari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nutrition and Food Science
Full name of responsible person
Razieh Khorramnazari
Position
MS Candidate in Nutrition
Other areas of specialty/work
Street address
School of Nutrition and Food Science. Across from Bargh Stadium, Razi Blvd.
City
Shiraz
Postal code
Phone
0098 71_372_51001
Fax
Email
khoramnazari@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nutrition and Food Science
Full name of responsible person
Razieh Khorramnazari
Position
MS Candidate of Nutrition
Other areas of specialty/work
Street address
School of Nutrition and Food Science. Across from Bargh Stadium, Razi Blvd.
City
Shiraz
Postal code
Phone
0098 71_372_51001
Fax
Email
khoramnazari@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)