This study was undertaken to assess the effect of comsumption of 1 cup cranberry juice by type 2 diabetic patients on serum paraoxonase-1 (PON-1) activity , apoA-1 ,apoB, glucose and Lp(a).
In a double- blind randomized clinical trial, 58 type2 diabetic male patients were randomly divided to received 1 cup cranberry juice (CJ) or placebo drink daily for 12 weeks.Inclusion criteria were BMI more than 30 kg/m2 and HbA1c less than 9% .
Exclusion criteria were change in the use of medication for diabetes ; hypertension ; dyslipidemia or anti-platelet in the previous 2 months ; pregnancy or breastfeeding. There were significant decrease in serum glucose and apoB (p<0.05 and p<0.01, respectively) and significant increase in serum apoA-1 and PON-1 activity (p<0.05 and p<0.01, respectively) at the end of study in CJ group compare to control group. Conclusion : 1 cup cranberry juice for 12 weeks is effective in reducing serum glucose and apoB and increasing apoA-1 and PON-1 activity, so may have favorite effects on reducing CVD risk factors in type 2 diabetic male patients
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111272709N23
Registration date:2011-12-24, 1390/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-24, 1390/10/03
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-08-15, 1388/05/24
Expected recruitment end date
2011-03-23, 1390/01/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of cranberry juice on serum glucose, apoB, apoA-I, Lp(a) and Paraoxonase-1 activity in type 2 diabetic male patients.
Public title
The Effects of cranberry juice in type 2 diabetic male patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: BMI more than 30 kg/m2; HbAlc less than 9% ; serum triglyceride < 400mg/d1 ; serum total cholesterol< 240mg/d1; taking oral hypoglycemic agents but not insulin.
Exclusion criteria:A recent (within previous 3 months) or past history of symptomatic heart disease ; myocardial infarction ; angina pectoris or stroke ; surgery ; liver ; renal (plasma creatinine >1.62 mg/d1) or thyroid disease; use of steroids or drugs with unknown components ; change in the use of medication for diabetes ; hypertension ; dyslipidemia or anti-platelet in the previous 2 months ; pregnancy or reastfeeding.
Age
From 25 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
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
School of Medicine,Tehran University of Medical sciencesa
Street address
Central building of Tehran University of Medical Sciences, Intersection of Qods Avenue and Bulvard Keshavarz
City
Tehran
Postal code
Approval date
2010-01-18, 1388/10/28
Ethics committee reference number
3248
Health conditions studied
1
Description of health condition studied
IV Endocrine, nutritional and metabolic diseases
ICD-10 code
E(E00-E90)
ICD-10 code description
E11
Primary outcomes
1
Description
Lp(a)
Timepoint
12 weeks
Method of measurement
Laboratory kits
2
Description
glucose
Timepoint
12 weeks
Method of measurement
laboratory kits
3
Description
Paraoxonase-1
Timepoint
12 weeks
Method of measurement
Laboratory kits
4
Description
ApoB
Timepoint
12 weeks
Method of measurement
laboratory kits
5
Description
Apoa-I
Timepoint
12 weeks
Method of measurement
laboratory kits
Secondary outcomes
1
Description
Weight
Timepoint
12 weeks
Method of measurement
electronic scale
2
Description
Body mass index
Timepoint
12 weeks
Method of measurement
Weight/height2
3
Description
Waist circumference
Timepoint
12 weeks
Method of measurement
nonstrechable tape
Intervention groups
1
Description
A double-blind randomized clinical trial of parallel design was used. During a 2-week baseline period, participants continued their usual diet without any cranberry (Run-in period), then in intervention group Patients consumed 1 cup (240m1) cranberry juice (CJ group) for 12 weeks.Thirty, nonsmoking type 2 diabetes(T2D) male patients were recruited from the Endocrine Research Center of Tehran University of Medical sciences (TUMS), Tehran, Iran from Sep 2009 to March 2011.All patients were asked to maintain their usual diet and physical activity level and not to alter their lifestyle during the intervention. Twenty-nine patients in intervention group ended the study.
Category
Treatment - Other
2
Description
A double-blind randomized clinical trial of parallel design was used. During a 2-week baseline period, participants continued their usual diet without any cranberry (Run-in period), then in control group patients consumed 1 cup (240m1) placebo drink (natural mineral water with strawberry flavor) for 12 weeks.Thirty, nonsmoking type 2 diabetes(T2D) male patients were recruited from the Endocrine Research Center of Tehran University of Medical sciences (TUMS), Tehran, Iran from Sep 2009 to March 2011.All patients were asked to maintain their usual diet and physical activity level and not to alter their lifestyle during the intervention. Twenty-nine patients in control group ended the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine and Research Center(Tehran University of Medical Sciences)
Full name of responsible person
Dr. mohammad ebrahim Khamseh
Street address
Endocrine and Research Center-Firozgar Education Center-Behafarin Avenue-Valiasr Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbass motevalian
Street address
Deputy of Researches and Technology, Central Building of Tehran University of Medical Sciences , Intersection of Qods Avenue and Bulvard Keshavarz
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical sciences
Full name of responsible person
Farzad Shidfar
Position
Associate Professor
Other areas of specialty/work
Street address
School of Health, No 52, Alvand Avenue, Argantine Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
+98 88779487
Email
farzadshidfar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Associate Professor
Other areas of specialty/work
Street address
School of Health,No. 52, Alvand Avenue, Argantine Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
+98 21 8877 9487
Email
farzadshidfar@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)