The aim of this study is to evaluate the possible effects of daily intake of carrot juice fortified with 10 mg beta carotene on inflammatory factors, lipids, glycemic control in patients with type 2 diabetes (T2DM). To do this, 44 diabetic patients will be selected. Patients will be assigned randomly to one of the 2 intervention groups. 1. Plain carrot juice .2, carrot juice fortified with 10 mg beta carotene Each patient will consume 200 ml of carrot juice every day for 2 months with lunch and dinner. At the first and last visits, anthropometric, dietary and laboratory assessments will be performed for all patients. Primary outcomes are improvement in glycemic, inflammatory and lipid markers and secondary outcome is prevention of long-term diabetic complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812113465N1
Registration date:2011-12-19, 1390/09/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-19, 1390/09/28
Registrant information
Name
farideh tahbaz
Name of organization / entity
faculty nutrition and food science shahid beheshti university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7484
Email address
f_tahbaz@nnftri.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and food Technology Research institute, Shahid Beheshti University of Medical Sciences & Health Services
Expected recruitment start date
2009-12-23, 1388/10/02
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of carrot juice fortified with beta carotene on inflammatory factors, lipid profile and glycemic control in type 2 diabetes patient.
Public title
Carrot juice fortified with beta carotene and diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion: age between 40-65 years old, FBS Equal or geater than 126 mg/dl, non smoking patients,
exclusin criteria: CRP > 10 mg/l , not taking multivitamins and minerals, not using insulin and fat lowering drugs
Age
From 40 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
f_tahbaz@nnftri.ac.ir
Secondary trial Id
-
Registration date
2011-12-18, 1390/09/27
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and food Technology Research institute, Shahid Beheshti University of Medical Sci
Street address
West Arghavan St., Farahzadi Blvd., Shahrak Qods,
City
tehran
Postal code
1981619573
Approval date
2009-09-24, 1388/07/02
Ethics committee reference number
4356
2
Ethics committee
Name of ethics committee
National Nutrition and food Technology Research institute, Shahid Beheshti University of Medical Sci
Street address
tehran- West Arghavan St., Farahzadi Blvd., Shahrak Qods,
City
tehran
Postal code
1981619573
Approval date
2009-09-04, 1388/06/13
Ethics committee reference number
4356
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E 11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
assessment of serum beta carotene
Timepoint
At the beginning and after 2 months intervention.
Method of measurement
with HPLC
2
Description
assessment of serum inflammatory factors CRP, IL6
Timepoint
At the beginning and after 2 months intervention.
Method of measurement
with ELISA
3
Description
assessment of serum lipid profile TC,TG,LDL-C,HDL-C
Timepoint
At the beginning and after 2 months intervention.
Method of measurement
with autoanalyzer
4
Description
assessment of serum glycemic control such as fasting Glucose
Timepoint
At the beginning and after 2 months intervention.
Method of measurement
with autoanalyzer
5
Description
IR و LDL/HDL و TC/HDL
Timepoint
At the beginning and after 2 months intervention.
Method of measurement
calculate
Secondary outcomes
1
Description
improvement of serum antioxidant such as beta-carotene , complication in type 2 diabetic patient
Timepoint
Baseline and 2 month after intervention
Method of measurement
assessment of serum factors and improvement of health in patient
2
Description
improvement of inflammatory factors
Timepoint
Baseline and 2 month after intervention
Method of measurement
with instrument
3
Description
improvement of serum lipid profile
Timepoint
Baseline and 2 month after intervention
Method of measurement
with instrument
4
Description
improvement of glycemic profiles
Timepoint
Baseline and 2 month after intervention
Method of measurement
with instrument
Intervention groups
1
Description
intervention group 1: fortified carrot juice with10 mg beta-carotene
Category
Treatment - Other
2
Description
intervention group 2: 200 ml plain carrot juice per 200 mL group
Category
Treatment - Other
3
Description
group 1 :with their lunch (this was exchanged with one serving of bread). 8 weeks
Category
Treatment - Drugs
4
Description
group 2 : with their lunch (this was exchanged with one serving of bread). 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
National nutrition and food technology research institute
Full name of responsible person
Dr Farideh Tahbaz
Street address
West Arghavan St., Farahzadi Blvd., Shahrak Qods,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and food Technology Research institute, Shahid Beheshti University of Medical Sci
Full name of responsible person
Dr Majid hajifaraji
Street address
West Arghavan St., farahzadi Blvd., Shahrak Qods
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and food Technology Research institute, Shahid Beheshti University of Medical Sci
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
Faculty of Nutrition and food Technology , Shahid Beheshti University of Medical Sciences & Health
Full name of responsible person
Atena Ramezani
Position
M.S student in Nutrition and at peresent ph.D student in Nutrition in Tehran ,University of Medical
Other areas of specialty/work
Street address
West Arghavan St., Farahzadi Blvd., Shahrak Qods,
City
Tehran
Postal code
19395/4741
Phone
+98 21 2235 7484
Fax
-
Email
ramezaniatena@yahoo.com
Web page address
atena.ramezani62@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition and food Technology, Shahid Beheshti University of Medical Sciences & Health Se
Full name of responsible person
Dr Farideh Tahbaz
Position
Associate Professor/PhD in nutrition
Other areas of specialty/work
Street address
West Arghavan St., Farahzadi Blvd., Shahrak Qods
City
Tehran
Postal code
19395/4741
Phone
+98 21 2235 7484
Fax
Email
f_tahbaz@nnftri.ac.ir, farideh.tahbaz@gmail.com
Web page address
www.nnftri.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nutrition and Food Technology , Shahid Beheshti University of Medical Sciences & Health S
Full name of responsible person
Atena Ramezani
Position
M.S student in Nutrition, at peresent: ph.D student in Nutrition, Tehran,University of Medical Scien
Other areas of specialty/work
Street address
West Arghavan St., Farahzadi Blvd., Shahrak Qods
City
Tehran
Postal code
-
Phone
+98 21 3324 0685
Fax
-
Email
ramezaniatena@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)