In this randomized cross-over study in healthy volunteers, 30 healthy subjects aged 19–59 years will be selected. The purpose of this study, is to investigate the effect of natural and commercial orange juice consumption on pro-inflammatory cytokines, lipid profile levels, flow-mediated dilatation (FMD) and Blood pressure (BP) in healthy volunteers.
Individuals with a history of diabetes; cardiovascular disease; liver and kidney disease as well as those with thyroid disease; pregnant and breastfeeding; individuals with dyslipidemia, metabolic and endocrine diseases and those with a vegetarian diet will be exclude.
FMD measurement will done using high-frequency ultrasonography of the brachial artery, blood pressure gauge using a sphygmomanometer and the inflammatory markers (hs-CRP-ICAM-VCAM-IL-6-E-Selecti) and lipid profile levels will be measured using ELISA kits. Participants are randomly divided into two groups . And will consume 500mL orange juice(natural or commercial orange juice); twice a day with breakfast and dinner for 4 weeks, at the beginning and end of a 4-week period, above mentioned factors will be measured. And after a 2wk wash out (no consumption of oranges or orange juice) Groups will be changed and factors will be measured again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205079662N2
Registration date:2012-06-10, 1391/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-10, 1391/03/21
Registrant information
Name
Sedigheh Asgary
Name of organization / entity
Isfahan Cardiovascular Research Center ,Isfahan Cardiovascular Research institute , Physiology Re
Country
Iran (Islamic Republic of)
Phone
+98 31 1335 9090
Email address
s_asgari@crc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of natural and commercial orange juice consumption in blood pressure and inflammatory factors in healthy volunteers
Public title
Effects of natural and commercial orange juice consumption in inflammatory factors ( hs-CRP; ICAM; VCAM; IL-6; E-Selectin )and endothelial function evaluation (FMD ) in healthy volunteers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Healthy individuals 19-59 years.
Exclusion criteria: Individuals with a history of diseases; diabetes; cardiovascular disease; liver and kidney as well as those with thyroid disease; pregnant and breastfeeding; individuals with dyslipidemia, metabolic and endocrine diseases and those with a vegetarian diet.
Age
From 19 years old to 59 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar jirib st.
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
288028
Health conditions studied
1
Description of health condition studied
Blood pressure
ICD-10 code
I10-I15
ICD-10 code description
Hypertensive diseases
2
Description of health condition studied
flow-mediated dilatation (FMD)
ICD-10 code
I70-I79
ICD-10 code description
Diseases of arteries, arterioles and capillaries
Primary outcomes
1
Description
Positive changes in inflammatory markers
Timepoint
Baseline and after 4 weeks
Method of measurement
ELISA kit
2
Description
Positive changes in endothelial function
Timepoint
Baseline and after 4 weeks
Method of measurement
Doppler ultrasonography
Secondary outcomes
1
Description
Decrease in blood pressure
Timepoint
Baseline and after 4 weeks
Method of measurement
Sphygmomanometer
2
Description
Positive changes in lipid profiles
Timepoint
Baseline and after 4 weeks
Method of measurement
kit
3
Description
Cholesterol Level
Timepoint
Before and after 4 weeks
Method of measurement
KIT
4
Description
HDL Level
Timepoint
Before and after 4 weeks
Method of measurement
KIT
5
Description
LDL level
Timepoint
Before and after 4 weeks
Method of measurement
KIT
Intervention groups
1
Description
500 ml of fresh orange juice consumption in group 1 for 4wk
Category
Other
2
Description
500 ml of Commercial orange juice consumption in group 1, for 4wk.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sedigheh tahere Cardiovascular Research Center
Full name of responsible person
mahtab keshvari
Street address
Khorram Street, Jomhori Square
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.gholam hossin sadri
Street address
Hezar jirib St.
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
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
Isfahan Cardiovascular Research Center, Applied Physiology Research Center, Isfahan University of M
Full name of responsible person
Sedigheh Asgary
Position
Pharmacist and PhD Pharmacogenetics
Other areas of specialty/work
Street address
Khorram Street, Jomhoori Square
City
Isfahan
Postal code
Phone
+98 31133595959
Fax
Email
sasgary@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Cardiovascular Research Center
Full name of responsible person
Mahtab keshvari
Position
MSc / BSc Research
Other areas of specialty/work
Street address
Cardiovascular Research Center, Khorram Street, Jomhoori Square
City
Isfahan
Postal code
Phone
+98 31133595959
Fax
Email
mahtabkeshvari87@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)