Protocol summary

Summary
Increased lipid profile after each meal can disturb the endothelial function. The present study assessed the effects of bread supplemented with oat bran on serum lipids and endothelial dysfunction in patients with hypercholesterolemia. This randomized controlled clinical trial was conducted on 60 patients (age: 20-60 years old) who were receiving statins for hypercholesterolemia. The subjects were selected from hypercholesterolemic participants in outpatient clinics. Individuals with diabetes type one or two, hypothyroidism, renal failure, anemia, cholestasis, pancreatic cancer or malignancy, and secondary dyslipidemia were not included. Patients who used antihypertensive drugs or alcohol, smoked, did vigorous regular exercise, had a history of eating disorders, or had weight changes (losing or gaining more than three kilogram weight during the three months prior to the study) were not included, either. The subjects were randomly allocated to either intervention (consuming at least five daily servings of oat bread with 6 g beta-glucagon) or control (receiving at least five servings of wheat bread). Anthropometric indicators, fasting blood sugar and lipid profiles ere measured at baseline and in the end of intervention. Endothelial function was assessed using flow-mediated dilation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201312073733N3
Registration date: 2014-01-03, 1392/10/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-01-03, 1392/10/13
Registrant information
Name
Masoumeh Sadeghi
Name of organization / entity
Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1335 9696
Email address
roohafza@crc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2013-03-01, 1391/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of hull-less barley bread on lipid profile, fasting blood sugar and effective factors on vascular endothelial function in hypercholestrolemic patients
Public title
Investigation the effect of hull-less barley bread on lipid profile, fasting blood sugar and effective factors on vascular endothelial function in hypercholestrolemic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age 25-65 years old; hypercholesterolemia patients who receiving statins for hypercholesterolemia. Exclusion criteria: Diabetes type one or two; hypothyroidism; renal failure; anemia; cholestasis; pancreatic cancer or malignancy; secondary dyslipidemia; used antihypertensive drugs; alcohol; smoked; did regular exercise; had a history of eating disorder; had weight changes (losing or gaining more than three kilogram weight during the three months prior to the study)
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan Cardiovascular Research Institute Isfahan University of Medical Sciences
Street address
Isfahan Cardiovascular Research Institute, Khorram, Ave
City
Isfahan
Postal code
Approval date
2012-10-27, 1391/08/06
Ethics committee reference number
91117

Health conditions studied

1

Description of health condition studied
Hypercholesterolemic
ICD-10 code
E78.0
ICD-10 code description
Low-density-lipoprotein-type [LDL] hyperlipoproteinaemia

Primary outcomes

1

Description
Lipid Profile
Timepoint
Before and after intervention
Method of measurement
Autoanalyzer

2

Description
Fasting blood sugar
Timepoint
Before and after intervention
Method of measurement
Autoanalyzer

3

Description
flow-mediated dilation (FMD)
Timepoint
Before and after intervention
Method of measurement
FMD is a noninvasive technique where forearm ischemia is induced by inflating a sphygmomanometer cuff to 50-100 mmHg for five minutes.

Secondary outcomes

1

Description
Body mass index
Timepoint
before and after intervention
Method of measurement
Body mass index (BMI) was calculated as weight divided by height squared

2

Description
Hip circumference
Timepoint
before and after intervention
Method of measurement
measured based on standard protocols.

3

Description
waist circumference
Timepoint
before and after intervention
Method of measurement
measured based on standard protocols.

4

Description
blood pressure
Timepoint
before and after intervention
Method of measurement
after 20-minuterest, in sitting position

Intervention groups

1

Description
All subjects were provided with a hypo caloric diet in the calorie range of 1500- 2000 for 4 weeks. the intervention group received the hypocaloric diet containing an experimental bread rich in beta-glucan from oat bran (at least five servings (150 g) per day based on their needs, each serving of which had 6 gram beta-glucan). Their adherence to diet was checked weekly by a dietitian through a diary log in which the daily amounts of all consumed foods including bread were recorded. They were asked to continue their routine levels of physical activity and not to consume fiber supplements, weight loss drugs, herbals medicines, or laxatives. During the course of the intervention, the participants attended weekly visits with the mentioned resident and nutritionist (who evaluated their daily intake of food items.
Category
Prevention

2

Description
All subjects were provided with a hypo caloric diet in the calorie range of 1500- 2000 for 4 weeks. The control group consumed the hypocaloric diet with control bread rich in wheat fiber (at least five servings (150 g) per day based on their needs, with no beta-glucan). Their adherence to diet was checked weekly by a dietitian through a diary log in which the daily amounts of all consumed foods including bread were recorded. They were asked to continue their routine levels of physical activity and not to consume fiber supplements, weight loss drugs, herbals medicines, or laxatives. During the course of the intervention, the participants attended weekly visits with the mentioned resident and nutritionist (who evaluated their daily intake of food items.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Cardiovascular Research Institute
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan Cardiovascular Research Institute
Full name of responsible person
Dr. Masoumeh Sadeghi
Street address
Sedighe Tahereh Center, Khorram Ave, Jomhouri square
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Cardiovascular Research Institute
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mr. Toghyani
Street address
School of Medicine, Isfahan University of Medical Sciences, Hezar jerib Ave
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
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
Isfahan Cardiovascular Research Institute
Full name of responsible person
Dr Hamidreza Roohafza
Position
Assistant Professor
Other areas of specialty/work
Street address
Isfahan Cardiovascular Research Institute,Sedighe Tahereh Research Center, khorram Ave
City
Isfahan
Postal code
Phone
+98 31 1335 9090
Fax
Email
hroohafza@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Masoumeh Sadeghi
Position
Associate Professor
Other areas of specialty/work
Street address
Isfahan Cardiovascular Research Institute, Sedigheh Tahereh Research Center, khorram Ave
City
Isfahan
Postal code
Phone
+98 31 1335 9090
Fax
Email
sadeghimasoumeh@gmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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