Study of quercetin supplementation on risk factors for cardiovascular disease, inflammatory biomarkers and oxidative stress and the relationship between physical activity level in women with type 2 diabetes
This study investigated the effect of Quercetin supplementation on cardiovascular disease risk factors, inflammatory biomarkers and oxidative stress and correlation with physical activity level in women with type 2 diabetes. This study is a randomized clinical trial On 72 women 55-35 years. daily supplement group receiving One 500 mg capsule quercetin and placebo group receiving An identical placebo capsules for 10 weeks. 10cc blood sample will be collected at the beginning and end of intervention to assess the Indicators related to cardiovascular disease risk factors (Total Cholesterol, LDL-c, HDL-c, triglycerides, blood pressure) Indicators of oxidative stress(TAC,MDA) Inflammatory indices(TNFα , hs-CRP,IL-6) and The glycemic index(HbA1c، FBS). Food intake assessed by food records in First, the fifth week and The tenth week. .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011015062N1
Registration date:2011-12-07, 1390/09/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-07, 1390/09/16
Registrant information
Name
Reza Ghiasvand
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2742
Email address
ghiasvand@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Isfahan University of Medical Sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2011-10-06, 1390/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of quercetin supplementation on risk factors for cardiovascular disease, inflammatory biomarkers and oxidative stress and the relationship between physical activity level in women with type 2 diabetes
Public title
The effect of quercetin supplementation in women with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria
1. Willingness to participate in the study
2. Type 2 diabetes diagnosed by a physician
3. Having a history of diabetes at least 3 years
4. Age between 35-55 years
5. Not smoking and addiction
6. Lack of severe heart disease, stroke, liver disease, renal, gastrointestinal, thyroid, parathyroid, rheumatoid arthritis and infectious disease
7. Lack of insulin
8. Lack of antioxidant supplements in the previous month
9. Lack of pregnancy and lactation
Exclusion criteria
1. Need to change the dose and type of drug from the baseline to the end
2. Occurring in pregnancy
3. Less than 70% adherence
4. Unwillingness to continue reading
5. Staying beyond the fixed type and dose of drugs during the intervention.
6. There are diseases that require special treatment
Age
From 35 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Isfahan Regional Bioethics Committie
Street address
hezargerib street -Isfahan
City
Isfahan
Postal code
81745319
Approval date
2011-06-20, 1390/03/30
Ethics committee reference number
190022
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin dependent type2 diabetes
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
befor start and end of study
Method of measurement
Mercury Barometer - mmHg
2
Description
total Cholesterol
Timepoint
befor start and end of study
Method of measurement
Enzymatically-mg/dl
3
Description
HDL-c
Timepoint
befor start and end of study
Method of measurement
Enzymatically-mg/dl
4
Description
LDL-c
Timepoint
befor start and end of study
Method of measurement
Enzymatically-mg/dl
5
Description
TG
Timepoint
befor start and end of study
Method of measurement
Enzymatically-mg/dl
6
Description
FBS
Timepoint
befor start and end of study
Method of measurement
Enzymatically-mg/dl
7
Description
HbA1c
Timepoint
befor start and end of study
Method of measurement
Enzymatically-mg/dl
8
Description
MDA
Timepoint
befor start and end of study
Method of measurement
ELISA-ng/ml
9
Description
total antioxidant capacity
Timepoint
befor start and end of study
Method of measurement
Chemical colorimetric-mmol/L
10
Description
TNF-α
Timepoint
befor start and end of study
Method of measurement
ELISA-pg/ml
11
Description
hs-CRP
Timepoint
befor start and end of study
Method of measurement
ELISA-mg/L
12
Description
IL-6
Timepoint
befor start and end of study
Method of measurement
ELISA-pg/ml
13
Description
diastolic blood pressure
Timepoint
befor start and end of study
Method of measurement
Mercury Barometer - mmHg
Secondary outcomes
1
Description
Physical Activity
Timepoint
before start and end of sudy
Method of measurement
IPAQ Questionnaire-Met.minutes/week
2
Description
Weight
Timepoint
before start and end of sudy
Method of measurement
Weight gauge-Kg
3
Description
food intake
Timepoint
First, the fifth week, the tenth week
Method of measurement
Inventory Software N4
4
Description
The waist to hip circumference
Timepoint
before start and end of sudy
Method of measurement
Tape-Centimeter
Intervention groups
1
Description
The intervention group received daily 500mg capsule quercetin for 10 weeks
Category
Treatment - Other
2
Description
control group received 500mg placebo(lactose) daily for 10 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Endocrinology and Metabolism
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Isfahan University of Medical Sciences field
Full name of responsible person
Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Isfahan University of Medical Sciences field
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Reza Ghiasvand
Position
Ph.D. in Nutritional Sciences
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences. Hezarjerib St. Isfahan.
City
Isfahan
Postal code
Phone
+98 31 1792 2742
Fax
Email
ghiasvand@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)