The effects of freeze - dried strawberry powder on glucose and lipid profile, malondialdehyde (MDA), hs-CRP and serum total antioxidant capacity in type 2 diabetic patients
The aim of this randomized double blind clinical trial is to determine the effects of freeze dried strawberry consumption on some blood biochemical parameters in type 2 diabetic patients. Forty patients aged between 30-60 years old from both sexes are assigned into two groups. Patients in intervention group consume 2 cups of freeze dried strawberry beverage (50 g /day) and patients in control group consume 2 cups of placebo beverage with strawberry flavor (8g pectin and 24g lactose) for 6 weeks. Anthropometric and blood pressure measurements, 3-day 24h dietary recalls and fasting blood samples are collected at the beginning and at the end of study. Fasting blood sugar, glycosylated hemoglobin, lipid profile, malondialdehyde, total antioxidant capacity, and high sensitive C-reactive protein are measured. The participants are asked not to change their regular diet, medicine and activity during the study and refrain from other sources of berries, green tea, cocoa, and soy products while on the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110117765N1
Registration date:2012-08-02, 1391/05/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-02, 1391/05/12
Registrant information
Name
Sara Moazzen
Name of organization / entity
Ahvaz Joundishapour University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1380 1454
Email address
moazzen.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Joundishapour University of Medical Science
Expected recruitment start date
2011-04-10, 1390/01/21
Expected recruitment end date
2012-05-30, 1391/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of freeze - dried strawberry powder on glucose and lipid profile, malondialdehyde (MDA), hs-CRP and serum total antioxidant capacity in type 2 diabetic patients
Public title
Effect of strawberry powder on diabetes complications
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having type 2 diabetes; 30 to 60 years old; LDL level more than 100 mg/Dl.
Exclusion criteria: Having renal or hepatic failure; cardiovascular disease; thyroid disorders; lactose intolerance; treatment with insulin; taking corticosteroides, NSAIDS, cholesterol lowering drugs, multivitamin-mineral and fiber supplements; BMI more than 35 Kg/m2; smoking; pregnancy and lactation; use of multivitamin-mineral and fiber and antioxidant supplements 3 weeks prior to the study.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Joundishapour University of Medical Science
Street address
Glestan street
City
Ahvaz
Postal code
Approval date
2012-03-11, 1390/12/21
Ethics committee reference number
ETH_393
Health conditions studied
1
Description of health condition studied
None-insulin dependant diabetese mellistus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Sugar
Timepoint
baseline and after 6 weeks
Method of measurement
spectrophotometry
2
Description
Hemoglobin A1c
Timepoint
baseline and after 6 weeks
Method of measurement
Chromatography
3
Description
Total Cholesterol
Timepoint
Baseline and after 6 weeks
Method of measurement
Spectrophotometry
4
Description
Triglyceride
Timepoint
Baseline and after 6 weeks
Method of measurement
Spectrophotometry
5
Description
LDL
Timepoint
Baseline and after 6 weeks
Method of measurement
Friedewald Formula
6
Description
HDL
Timepoint
Baseline and after 6 weeks
Method of measurement
Spectrophotometry
7
Description
Malondialdehyde
Timepoint
Baseline and after 6 weeks
Method of measurement
Spectrophotometry
8
Description
Total Antioxidant Capacity (TAC)
Timepoint
Baseline and after 6 weeks
Method of measurement
Spectrophotometry
9
Description
hsCRP
Timepoint
Baseline and after 6 weeks
Method of measurement
Immunotorbidometry
Secondary outcomes
1
Description
Dietary Factors
Timepoint
Baseline and after 6 weeks
Method of measurement
3-day 24h dietary recalls
2
Description
Body Mass Index
Timepoint
Baseline and after 6 weeks
Method of measurement
Formula
3
Description
Blood Pressure
Timepoint
Baseline and after 6 weeks
Method of measurement
Sphygmomanometer
Intervention groups
1
Description
Intervention Group: 2 cups of strawberry beverage containing 50 gr of freeze dried strawberry daily for 6 weeks
Category
Treatment - Drugs
2
Description
Control Group: 2 cups of Placebo beverage, containing 32 gr of placebo powder ( containing 24 g lactose and 8 g pectin ), daily for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Diabetes Research Center
Full name of responsible person
Dr Reza Amani
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Joundishapour University of Medical Science
Full name of responsible person
Dr Reza Amani
Street address
Golestan street
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Joundishapour University of Medical Science
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
Para medicine Faculty, Ahvaz Joundishapour University of Medical Science
Full name of responsible person
Dr Reza Amani
Position
Associate Professor in Department of Nutrition
Other areas of specialty/work
Street address
Golestan street
City
Ahvaz
Postal code
Phone
+98 61 1373 8319
Fax
+98 61 1373 8330
Email
rezaamani@hotmail.com, sm.yaghmur@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Joundishapour University of Medical Science
Full name of responsible person
Sara Moazzen
Position
MSc Student of Nutrition Science
Other areas of specialty/work
Street address
Golestan street
City
Ahvaz
Postal code
Phone
+98 61 1373 8319
Fax
Email
sm.yaghmur@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Joundishapour University of Medical Science
Full name of responsible person
Sara Moazzen
Position
MSc Student of Nutrition Science
Other areas of specialty/work
Street address
Nutrition Department, Para medicine Faculty, Golestan street
City
Ahvaz
Postal code
Phone
+98 37 38319
Fax
+98 61 1373 8330
Email
Sm.yaghmur@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)