Effect of coenzyme Q10 Supplementation on Metabolic Syndrome Parameters, lipid peroxidation, hs-CRP and homocysteine in patients with metabolic syndrome.
In this study, the people in intervention and control group are chosen by using the method of random sampling among patients with metabolic syndrome, they were chosen in the KER CARDS project which is a population study in the city of Kerman from 1388-1390.It is done so that 60 of the patients will be chosen according to the standards of entering the study and will be divided to two control and intervention groups by using random allocation software.In the beginning of the study Anthropometric measurements are done. 10cc blood sample after fasting 8 to 12 hours for measurement of HDL cholesterol, triglycerides, LDLCholesterol, total cholesterol, fasting blood sugar (FBS), homocysteine, MDA and hs-CRP levels is collected. After avoiding any body activity for 5 minutes, blood pressure of the person is measured and after another 5 minutes of rest, it is measured again and we use the mean of these two blood pressures. After the primary measurements 200 mg coenzyme Q10 is prescribed daily for intervention group and placebo for control group. After the intervention period for 3 months all the measurements mentioned above is done again to survey any changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101311092N2
Registration date:2012-11-12, 1391/08/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-12, 1391/08/22
Registrant information
Name
Najmeh Rafiei Moghadam
Name of organization / entity
Shahid Sadoghi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
rafiee.najmeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences and Health Services
Expected recruitment start date
2012-10-20, 1391/07/29
Expected recruitment end date
2012-10-25, 1391/08/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of coenzyme Q10 Supplementation on Metabolic Syndrome Parameters, lipid peroxidation, hs-CRP and homocysteine in patients with metabolic syndrome.
Public title
Effect of Q10 in the treatment of metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Having the metabolic syndrome according to the NCEP ATP III definition:
According to the NCEP ATP III definition of having at least 3 of the following conditions:
a)Abdominal obesity (waist circumference ≥102 cm in men and≥ 88 cm in women)
b) High blood pressure (systolic blood pressure≥130 mm Hg and / or diastolic blood pressure≥85 mm Hg)
c)Low HDL-C (< 40 mg/ dl in men and < 50 mg/ dl in women)
d)TG ≥150 mg/ dl
e)FBS ≥100 mg/ dl
2.Being the age limit from 35 to 55 years
3.Patients with hypertension treated with anti-hypertensive drugs in the past 3 months have not changed and changes in drug therapy not occure during the study period.
4.Patients with diabetes who their treatment in the past 6 weeks has not changed
(Changes in drug therapy not occur during the study period )
5. Consent to participate in the study.
Exclusion criteria:
1.Statin use in the last month
2.History of cardiovascular disease in the past three months
3.Having an active infection
4.Risk of renal failure
5.Liver disease (viral hepatitis, treatments for liver disease)
6.Alcohol Consumption
7.Pregnancy or taking contraceptive drugs
8.History of hospitalization in the past 2 months
9.consumption of Nutritional supplements such as vitamins, trace elements, antioxidants
Age
From 35 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Yazd Univesity of Medical Sciences Ethics Committee
Street address
Bahonar Square
City
Yazd
Postal code
8916978477
Approval date
2012-07-07, 1391/04/17
Ethics committee reference number
51242 / 1/ 17/پ
Health conditions studied
1
Description of health condition studied
Metabolic Syndrome
ICD-10 code
E78.8
ICD-10 code description
Other disorders of lipoprotein metabolism
Primary outcomes
1
Description
Fasting Plasma Glucose
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Enzymatic methods
2
Description
HDL Cholesterol
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
colorimetry
3
Description
Blood pressure
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
sphygmomanometer
4
Description
waist circumference
Timepoint
at the begining of the study and3 month after intervention
Method of measurement
tape
5
Description
TG
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Enzymatic methods
6
Description
malondialdehyde
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
thiobarbituric acid method
7
Description
hs-CRP
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
ELISA
8
Description
Homocysteine
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
colorimetry
Secondary outcomes
1
Description
total cholesterol
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
colorimetry
2
Description
Anthropometric indicators: weight, height, body mass index, waist circumference, hip circumference and waist to hip ratio
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
Standard procedures using scale, tape and equations
3
Description
LDL cholesterol
Timepoint
at the begining of the study and 3 month after intervention
Method of measurement
colorimetry
Intervention groups
1
Description
Intervention group:Q10,100 mg soft gel capsule twice a day for 3 month
Category
Treatment - Drugs
2
Description
Placebo group: placebo tablets containing 100 mg of soy oil twice a day for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Physiology Research Center
Full name of responsible person
Dr Gholamreza Usefzadeh
Street address
Shariati Av
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University Of Medical Sciences
Full name of responsible person
Dr Hassan Mozaffari Khosravi
Street address
Bahonar sq
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Kerman Physiology Research Center
Full name of responsible person
Dr Gholamreza Usefzadeh
Position
Specialist in endocrinology and metabolism
Other areas of specialty/work
Street address
Shariati Ave
City
Kerman
Postal code
Phone
+98 34 1245 9003
Fax
Email
uousefzadeh@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoghi University of Medical Sciences
Full name of responsible person
Dr Azadeh Najarzadeh
Position
PHD,nutrition
Other areas of specialty/work
Street address
Bahonar Sq
City
Yazd
Postal code
Phone
+98 35 1623 8505
Fax
Email
azmm1383@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoghi University Of Medical Sciences
Full name of responsible person
Najmeh Rafiei Moghadam
Position
MS student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Bahonar Sq
City
Yazd
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)