The purpose of the present study is to evaluate the antioxidant effect of quercetin supplementation on the glycemic control, lipid profile and oxidative stress in type 2 diabetic patients, due to the high prevalence of the disease.
In an 8 week single-blind placebo-controlled clinical trial, 44 diabetic patients are randomly assigned into two groups, the interventional (consuming 250-mg quercetin supplement) and the control (consuming cellulose as placebo). Fasting blood samples are taken at the beginning and at week 8 for measuring glucose, insulin, and glycosylated hemoglobin (HbA1C), lipid profile and oxidative stress parameters. Dietary data are also obtained using 24-hour recalls at baseline and at the endpoint of the study.
At the end of the study, mean differences of the meseared parameters of the intervention and control groups are analyzed statically.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101911168N1
Registration date:2013-01-03, 1391/10/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-03, 1391/10/14
Registrant information
Name
Seyedeh Maryam Abdollahzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3649 1126
Email address
abdolahsm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of medical Sciences
Expected recruitment start date
2012-07-05, 1391/04/15
Expected recruitment end date
2012-12-05, 1391/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The antioxidant effect of quercetin supplementation on the glycemic control, lipid profile and oxidative stress in type 2 diabetic patients.
Public title
The effects of Quercetin on the management of diabetes mellitus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age range 35-60 years; having controlled diabetes (no need for changes in oral hypoglycemic medication during the study or having HbA1C <7%, pre-prandial capillary blood glucose <150 mg/dl and peak postprandial capillary blood glucose <180 mg/dl); maximum period of 10 years from the diagnosis of the disease; having normal blood pressure (systolic and diastolic blood pressure: <120 mmHg and <80 mmHg, respectively).
Exclusion criteria: smoking and/or drinking alcohol; having documented liver/kidney and/or lung diseases, kidney stone or any other type of chronic and/or acute inflammatory disorder; taking any lipid lowering and/or hypotensive medication and multi-vitamin mineral supplements; having documented clinically significant secondary complication of the disease (i.e. diabetic retinopathy, nephropathy and neuropathy)
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Iran- Fars- Shiraz- Zand St.-Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2012-10-07, 1391/07/16
Ethics committee reference number
CT-91-6271
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10-E14
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
FBS
Timepoint
Baseline and at the endpoint (after 8 weeks) of the trial
Method of measurement
mg/dl, by using auto-analyzer
2
Description
Insulin
Timepoint
Baseline and at the endpoint (after 8 weeks) of the trial
Method of measurement
microU/ml, by using an ELISA kit
3
Description
Hb A1C
Timepoint
Baseline and at the endpoint (after 8 weeks) of the trial
Method of measurement
percentage(%), by using HPLC method
4
Description
Triglyceride
Timepoint
Baseline and at the endpoint (after 8 weeks) of the trial
Method of measurement
mg/dl, by using auto-analyzer
5
Description
total-cholesterol
Timepoint
Baseline and at the endpoint (after 8 weeks) of the trial
Method of measurement
mg/dl, by using auto-analyzer
6
Description
LDL-cholesterol
Timepoint
Baseline and at the endpoint (after 8 weeks) of the trial
Method of measurement
mg/dl, by using auto-analyzer
7
Description
HDL-cholesterol
Timepoint
Baseline and at the endpoint (after 8 weeks) of the trial
Method of measurement
mg/dl, by using auto-analyzer
8
Description
ox-LDL
Timepoint
Baseline and at the endpoint (after 8 weeks) of the trial
Method of measurement
U/L, by using ELISA kit
9
Description
Total Antioxidant Capacity
Timepoint
Baseline and at the endpoint (after 8 weeks) of the trial
Method of measurement
nmol/mL, by using an ELISA kit
Secondary outcomes
empty
Intervention groups
1
Description
Quercetin, an oral 250-mg dietary supplement, once daily, for 8 weeks
Category
Other
2
Description
Acetate cellulose, an oral 250-mg dietary supplement, once daily, for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic, Shiraz
Full name of responsible person
Seyede Maryam Abdollahzadeh
Street address
Nemazee Square, Shiraz, Fars.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahmeddini
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Fars.
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
Shiraz University of Medical Sciences
Full name of responsible person
Seyedeh Maryam Abdollahzadeh
Position
MSc Student in Nutrition
Other areas of specialty/work
Street address
School of Health and Nutrition, Shiraz University of Medical Sciences, Shiraz, Fars.