Objective: To determine the effects of pomegranate juice consumption on blood pressure , lipid profile , inflammatory markers and oxidative stress in patients undergoing hemodialysis
Study design : Crossover clinical trial
Study population: Hemodialysis Patients
Inclusion criteria : patients undergoing hemodialysis treatment for more than 3 months , patients with ESRD undergoing hemodialysis three times a week for at least 90 days ; age 18 to 65 years, life expectancy greater than one year ; potassium level less than 5 mEq / L ;Let your doctor , informed consent to participate in the study
Non- inclusion criteria : cancer activist , has a digestive disorder that requires nutritional support preparations ; poor adherence to hemodialysis or drugs ;Kidney transplant less than 6 months ; taking antioxidant supplements such as vitamins E and C during one month prior to the study , the use of Vnvfr at least two weeks before the start of the study , patients hospitalized for more than 5 days in a month before registration; a history of thrombosis,Coronary artery bypass surgery and stroke in patients with acute infections or inflammatory disease ; patients who are pregnant or who plan to become pregnant during the study period .
Exclusion criteria : lack of pomegranate juice consumption by more than 3 days a month ; change the pressure medications and cholesterol ; non-compliance with dietary recommendations , hospitalization for more than 5 days in a month ; the loss of the conditions of entry to study
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070428797N1
Registration date:2016-07-24, 1395/05/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-24, 1395/05/03
Registrant information
Name
Reza Barati Boldaji
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3464 2735
Email address
stud4640075952@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-04-29, 1395/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pomegranate juice on blood pressure, lipids profile, inflammatory and oxidative stress biomarkers in hemodialysis patients
Public title
The effect of pomegranate juice on patients undergoing hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : patients undergoing hemodialysis treatment for more than 3 months , patients with ESRD undergoing hemodialysis three times a week for at least 90 days ; age 18 to 65 years, life expectancy greater than one year ; potassium level less than 5 mEq / L ;Let your doctor , informed consent to participate in the study
Non- inclusion criteria : AIDS, cancer activist , has a digestive disorder that requires nutritional support preparations ; poor adherence to hemodialysis or drugs ;Kidney transplant less than 6 months ; taking antioxidant supplements such as vitamins E and C during one month prior to the study , the use of Vnvfr at least two weeks before the start of the study , patients hospitalized for more than 5 days in a month before registration; a history of thrombosis,Coronary artery bypass surgery and stroke in patients with acute infections or inflammatory disease ; patients who are pregnant or who plan to become pregnant during the study period .
Exclusion criteria : lack of pomegranate juice consumption by more than 3 days a month ; change the pressure medications and cholesterol ; non-compliance with dietary recommendations , hospitalization for more than 5 days in a month ; the loss of the conditions of entry to study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz Zand Ave.
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.SUMS.REC.1394.210
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Baseline - 2 months , 3 months and 5 months after the start of the study
Method of measurement
Mercury manometers
2
Description
Diastolic blood pressure
Timepoint
Baseline - 2 months , 3 months and 5 months after the start of the study
Method of measurement
Mercury manometers
3
Description
TC
Timepoint
Baseline - 2 months , 3 months and 5 months after the start of the study
Method of measurement
kit
4
Description
LDL-C
Timepoint
Baseline - 2 months , 3 months and 5 months after the start of the study
Method of measurement
kit
5
Description
HDL-C
Timepoint
Baseline - 2 months , 3 months and 5 months after the start of the study
Method of measurement
kit
6
Description
TG
Timepoint
Baseline - 2 months , 3 months and 5 months after the start of the study
Method of measurement
kit
7
Description
Total Antioxidant capacity
Timepoint
Baseline - 2 months , 3 months and 5 months after the start of the study
Method of measurement
kit
8
Description
Malondialdehyde
Timepoint
Baseline - 2 months , 3 months and 5 months after the start of the study
Method of measurement
kit
9
Description
IL- 6
Timepoint
Baseline - 2 months , 3 months and 5 months after the start of the study
Method of measurement
kit
10
Description
Anthropometric indices
Timepoint
Baseline - 2 months , 3 months and 5 months after the start of the study
Method of measurement
Weighing scale,Tape measure,BIA
Secondary outcomes
1
Description
potassium
Timepoint
Baseline - 2 months , 3 months and 5 months after the start of the study
Method of measurement
blood test
Intervention groups
1
Description
In the first two months Group A: One hundred ml of pomegranate juice ; immediately after each dialysis session , three times a week for two months Group B: usual care in hemodialysis patients
Category
Treatment - Other
2
Description
In the second Group B: One hundred ml of pomegranate juice ; immediately after each dialysis session , three times a week for two months Group A: usual care in hemodialysis patients
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Reza Barati
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Reza Barati
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Akhlaghi
Street address
Boulevard Razi School of Nutrition and Food Science
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Sciences
Full name of responsible person
Reza Barati
Position
Masters student
Other areas of specialty/work
Street address
Razi Blvd. School of Nutrition and Food Sciences
City
Shiraz
Postal code
Phone
+98 71372510018
Fax
Email
reza93barati@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nutrition and Food Sciences
Full name of responsible person
Dr Akhlaghi
Position
Assistant Professor
Other areas of specialty/work
Street address
Razi Blvd. School of Nutrition and Food Sciences
City
Shiraz
Postal code
Phone
+98 71372510018
Fax
Email
msm.akhlaghi@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)