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IRCT20191109045382N1 IRCT 2019-12-07 Tabriz University of Medical Sciences The effect of lutein on cardiovascular risk factors The effect of lutein supplementation on anthropometric parameters, metabolic and inflammatory status, sirtuin1 and plasminogen activator inhibitor-1 in obese individuals on a low-calorie diet 2020-01-10 anticipated 46 Complete https://irct.ir/trial/43999 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 46 eligible participants will be randomly allocated to intervention and placebo groups using a software generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study, Blinding description: In this study, the main investigators (including the student and her supervisors and adviser professors), as well as the patients will be blinded to the type of the supplement (lutein or placebo) received by each group. The person responsible for preparing the supplement sachets (who is completely unrelated to the study) will be asked to assign a three-digit code to each of the two capsules (lutein and placebo) and keep the codes for himself until the end of the study and data analysis. 3 Cardiovascular diseases, obesity. Intervention group: Patients in this group will receive lutein supplement for 12 weeks. The supplement is a capsule containing 20 milligrams of lutein (a product by Bulk Supplements Co. and made in the United States) which will be used once a day with lunch.. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: Access starting 12 months after publication To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by other researchers, for conducting meta-analysis. Where to obtain: Ms. Fatemeh Hajizadeh-Sharafabad, E-mail address: fm.hajizadeh@gmail.com, cellphone number: 0098 9141894602 How to obtain: The applicant should provide a brief description of the aims and methods of his his Meta-analysis. His request will be assessed and, if agreed, the data will be emailed to the applicant. All these procedures will take no longer than 20 days. Comments:
public Dr. Zohreh Ghoreyshi
Faculty of Nutrition and Food Sciences., Attar Neishabouri St., Golghast St
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3336 2117 ghoreyshiz@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr Ali Tarighat-Esfanjani
Faculty of Nutrition and Food Sciences., Attar Neyshaburi St., Golghast St
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3336 2117 tarighata@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 46 individuals with obesity (BMI of 30-40 kg / m2) Pregnancy, lactation 45 years 64 years Both taking anti-diabetic drugs, statines, or anti-inflammatory drugs developing cardiovascular, renal and hepatic diseases, cancer. bariatrics surgeries Prevention Intervention group: Patients in this group will receive lutein supplement for 12 weeks. The supplement is a capsule containing 20 milligrams of lutein (a product by Bulk Supplements Co. and made in the United States) which will be used once a day with lunch. Anthropometric Indices. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Measurement of waist and hip circumference by a tape measure and body mass index (BMI) by dividing weight (kg) by height squared (m2). Calorie and macronutrients intake. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: The intake of calorie and macronutrients from the diet of the subjects with using a 3 day food record questionnaire and analysis by the nutritionist 4 program. Fasting blood sugar. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic method. Insulin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA. Lipid profile. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of total cholesterol, HDL- cholesterol and triglyceride through enzymatic methods and calculation of LDL- cholesterol by Friedewald equation. Insulin resistance. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Insulin resistance with HOMA-IR and calculation by this equation : [fasting insulin (mU / ml) × fasting glucose (mg / dl)] / 405. Inflammatory indices. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of serum hs-CRP by immunoturbidometry method and serum IL-6 by ELISA. Free fatty acids. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Chloromerer kit. Plasminogen activator inhibitor-1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA. Sirtuin1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA. Endothelin-1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA. Nitric oxide. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Chloromerer kit. Adiponectin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA. Leptin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA. Oxidative stress. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Prooxidant Antioxidant Balance (PAB). Tabriz University of Medical Sciences Approved 2019-10-15 The Research Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neishabouri Ave., Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)