Protocol summary

Summary
This experimental study is performed on 60 diabetic patients, among patients referred to Kashan Diabetes Center, divided into two groups: CPJ consumption (n=30) and control(n=30). Diabetic patients have fasting blood glucose below 150 mg/dl and do not took lipid lowering drugs. A questionnaire including anthropometric, medical and 24-hour food recall completed. Fasting blood samples before and after study are collected to measure glucose, HbA1c, TG, Chol, LDL and HDL. The patients consume CPJ 45 g/day for 3 months; then the variables are measured at the end of the study again. Both groups receive the same diet and physical activity advice during the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138711031576N1
Registration date: 2012-07-14, 1391/04/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-14, 1391/04/24
Registrant information
Name
Ali Akbar Rshidi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
rashidi@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2012-06-04, 1391/03/15
Expected recruitment end date
2013-06-05, 1392/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of concentrated pomegranate juice consumption on blood glucose and lipid concentrations in type 2 diabetic patients
Public title
Effect of concentrated pomegranate juice on treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: FBS< 150 mg/dl; not receiving lipid-lowering drugs and not receiving vitamin and mineral supplements Exclusion critera: using insulin for diabetes control; concentrated pomegranate juice sensitivity and receiving lipid-lowering drugs
Age
No age limit
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ravand Blv- Kashan University of Medical Sciences- Kashan- Iran
City
Kashan
Postal code
Approval date
2008-05-19, 1387/02/30
Ethics committee reference number
809

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E14
ICD-10 code description
Unspecified diabetes mellitus

Primary outcomes

1

Description
blood glucose level
Timepoint
before and 3 month after intervention
Method of measurement
enzymatic

2

Description
serum triglyceride level
Timepoint
before and 3 month after intervention
Method of measurement
photometry

3

Description
serum cholesterol level
Timepoint
before and 3 month after intervention
Method of measurement
photometry

4

Description
serum LDL level
Timepoint
before and 3 month after intervention
Method of measurement
photometry

5

Description
serum HDL level
Timepoint
before and 3 month after intervention
Method of measurement
photometry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: concentrated pomegranate juice, 45 g/d, 3 month
Category
Other

2

Description
control group: no intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan Diabetes Center
Full name of responsible person
Mrs Zinsaz
Street address
Kashan Diabetes Research-Emam Khomeiny street- Kashan- Iran
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Kashan University of Medical Sciences, Ravand Blv, Kashan, Iran
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Ali Akbar Rashidi
Position
faculty member/ MS.c
Other areas of specialty/work
Street address
Department of Biochemistry and Nutrition, school of Medicine, kashan university of medical sciences, Ravand Blv, kashan, Iran.
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
rashidi@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ali Akbar Rashidi
Position
MS.c
Other areas of specialty/work
Street address
Department of Biochemistry and Nutrition, school of Medicine, kashan university of medical sciences, Ravand Blv, kashan, Iran.
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
rashidi@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
kashan university of medical sciences
Full name of responsible person
Ali Akbar Rashidi
Position
Faculty member/MSc
Other areas of specialty/work
Street address
Department of Biochemistry and Nutrition, school of Medicine, kashan university of medical sciences, Ravand Blv, kashan,Iran.
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
rashidi@kaums.ac.ir
Web page address

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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