Effects of hydro-alcoholic artichoke leaf extract supplementation on metabolic and antioxidant status in patients with metabolic syndrome with regard to genetic polymorphism of CETP, TCF7L2 and FTO
This study is a double blind randomized clinical trial that aims in determining the effects of hydro-alcoholic artichoke leaf extract supplementation on metabolic and antioxidant status with regard to genetic polymorphism of CETP, TCF7L2 and FTO. It will be examined on 80 patients with metabolic syndrome. Blinding will be performed on patients and measuring the outcomes of study (researchers). At first the volunteers in the study will be observed in respect to inclusion criteria and qualified individuals will be asked to sign a written agreement. Venus blood samples of candidates will be collected and evaluated after 10-12 hours of fasting in respect of serum sugar and lipids. Also anthropometric measurements and blood pressure will be performed. Later, infected individual will be found out. In two groups they will be allocated in quadruple blocks: 1) supplement (daily intake of 1800 milligrams hydro-alcoholic artichoke leaf extract in the form of 4 tablets), 2)placebo (daily intake of 1800 milligrams placebo in the form of 4 tablets containing corn starch, lactose and avicel). Candidates will be requested to take one tablet before breakfast, 2 tablets before lunch and one tablet before dinner for the period of three months. Serum amount of sugar, lipid, insulin, CETP, total antioxidant capacity and MDA will be measured before and after intervention. Desired gens’ polymorphism will be determined based on RFLP-PCR method. The amount of food intake will be studied by using 3-days food-recall questionnaire, accompanying with anthropometric measurements and physical activity every 45 days as probabilistic confounder agents.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409033320N9
Registration date:2014-12-27, 1393/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-27, 1393/10/06
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
Expected recruitment start date
2014-11-21, 1393/08/30
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of hydro-alcoholic artichoke leaf extract supplementation on metabolic and antioxidant status in patients with metabolic syndrome with regard to genetic polymorphism of CETP, TCF7L2 and FTO
Public title
Effects of hydro-alcoholic artichoke leaf extract supplementation on metabolic and antioxidant status in patients with metabolic syndrome with regard to genetic polymorphism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: willingness and ability to collaborate on project ; aged between 20-60 years (both sexes); affected by metabolic syndrome: having at least 3 of 5 criteria according to international definition: waist circumference >91 cm in women and >89cm in men, serum glucose ≥100 mg/dl, serum triglyceride ≥150 mg/dl, HDL-C >40 mg/dl in men and >50 mg/dl in women, systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg
Exclusion criteria: Smoking ; Consumption of fish oil supplement or other antioxidant supplements currently or within 3 months before intervention; Consumption of lipid or blood pressure lowering drugs, corticosteroids currently or within 3 months before intervention; affected by cardiovascular disease, renal failure, diabetes mellitus, liver dysfunction, cancer; affected by Infectious or inflammatory disease or recent surgery; affected by malabsorption, such as sprue and Crohn's disease; affected by hypothyroidism or hyperthyroidism; having gallstones and biliary tract obstruction; having a weight loss diet at the time of the study; pregnancy or lactation; history of allergy to artichoke family plants and their products; menopause
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Approval date
2014-11-15, 1393/08/24
Ethics committee reference number
93120
Health conditions studied
1
Description of health condition studied
metabolic syndrom
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder, unspecified
Primary outcomes
1
Description
Fasting blood suger and Serum Lipid profile
Timepoint
at the beginning and end of intervention
Method of measurement
Fasting blood suger by enzymatic method and triglycerid, total cholestrol and HDL-C by espectrophotometry method and LDL-C by Friedewald Formula
2
Description
Serum levels of total antioxidants capacity and Malondialdehyde
Timepoint
at the beginning and end of intervention
Method of measurement
TAC: Espectrophotometry by Rabdox enzymatic kit; MDA: Reaction with thiobarbituric acid by fluorimetry method
3
Description
Serum level of CETP
Timepoint
at the beginning and end of intervention
Method of measurement
By Laboratory ELISA Kits
Secondary outcomes
1
Description
Energy and nutrient intake
Timepoint
3 times; at first, midst and the end of intervention
Method of measurement
3 dayes food record was used and analyzed with Nutritionist 4 software
2
Description
Serum level of Insulin
Timepoint
at the beginning and end of intervention
Method of measurement
Chemilumines
3
Description
Physical activity level
Timepoint
3 times; at first, midst and the end of intervention
Method of measurement
International questionnaire
4
Description
Systolic and Diastolic blood pressure
Timepoint
at the beginning and end of iintervention
Method of measurement
Automatic Blood Pressure Monitoring
5
Description
Anthropometric measurements
Timepoint
3 times during the study: at the beginning, midst and end of intervention
Method of measurement
Anthropometric measurements including weight using calibrated Omron scale with a precision of 0.1 kg and a minimum of clothes, height, waist and hip circumference using a tape measure with an accuracy of 0.1 cm will be done, and BMI will be calculated.
6
Description
Body composition
Timepoint
3 times during the study: at the beginning, midst and end of intervention
Method of measurement
Measurement of body composition using Omron Bioelectric Impedance Analyzer.
Intervention groups
1
Description
intervention group: 1800 mg hydro-alcoholic artichoke leaf extract as 4 tablets per day for 3 months
Category
Treatment - Other
2
Description
Control group: 1800 mg placebo containing corn starch, lactose and Avicel as 4 tablets per day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khoy City
Full name of responsible person
khatereh Rezazadeh
Street address
City
Khoy
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad - Reza Rashidi
Street address
Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research (VCR) of Tabriz 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
Ph.D Student of Nutrition
Full name of responsible person
khatereh Rezazadeh
Position
Faculty of Nutrition, Tabriz University Of Medical Sciences
Other areas of specialty/work
Street address
Faculty of Nutrition, Attar Neyshaboori Avenue, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3335 2292
Fax
Email
rezazadekhatereh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehranghiz Ebrahimi Mamaghani
Position
Associate Professor
Other areas of specialty/work
Street address
Faculty of Nutrition, Golgasht Street, Attar neishaboori Avenue
City
Tabriz
Postal code
Phone
+98 41 3335 2295
Fax
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
khatereh Rezazadeh
Position
Ph.D Student of Nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)