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IRCT20171107037302N1 IRCT 2017-12-26 Esfahan University of Medical Sciences curcumin supplementation in overweight/obese female students ندارد The effect of curcumin supplementation on anthropometric indices, glycemic indices, inflammatory markers, oxidative stress markers and chemerin in healthy overweight/obese female students 2017-10-09 anticipated 60 Complete https://irct.ir/trial/27993 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: students will be matched for BMI percentile. By using Stratified Blocked Randomization method, students will be assigned to intervention or control group, Blinding description: In this study, students will not be aware of type of received intervention. Furthermore, before the beginning of intervention, curcumin supplements and their placebo which are completely similar to each other will be coded to A and B by a third person rather than main researcher to keep blindness of study. The statistical analyzer will also be unaware of the allocation of treatments. N/A overweight and obesity. Intervention 1: Intervention group: Subjects in intervention group will receive 500 milligram curcumin supplements (1 per day) for 10 week. The curcumin supplements will provide from Karen pharmaceutical and dietary supplements company, Tehran, Iran. Based on body mass index percentile, subjects will receive a weigh maintenance or a mild weight loss diet (maximum half a kilogram per month). Intervention 2: Control group: Subjects in control group will receive placebo (1 per day) for 10 week. The placebo will provide from Karen pharmaceutical and dietary supplements company, Tehran, Iran. The placebo will completely similar in appearance with curcumin supplements. Based on body mass index percentile, subjects will receive a weigh maintenance or a mild weight loss diet (maximum half a kilogram per month). Undecided - It is not yet known if there will be a plan to make this available
public Mozhgan Nourian
Hezar jarib street, Isfahan University of Medical Sciences, Nutrition and Food Sciences School
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3172 Nourian@hlth.mui.ac.ir Esfahan University of Medical Sciences scientific Mozhgan Nourian
Hezar jarib street, Isfahan University of Medical Sciences, Nutrition and Food Sciences school
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3172 Nourian@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) overweight or obese girls (BMI percentile >=85 for age), age 13-18 years old, having menstural cycles far at least 6 months 13 years 18 years Female not consuming any drugs including drugs that could affect on lipid and carbohydrate metabolism such as statins and metformin, hormone therapy drugs, multivitamin-minerals, corticosteroids and nonsteroidal anti-inflammatory drugs no history of chronic diseases including diabetes, hypo- and hyperthyroidism, liver or renal diseases, cardiovascular diseases, polycystic ovary syndrome Treatment - Other Treatment - Other Intervention group: Subjects in intervention group will receive 500 milligram curcumin supplements (1 per day) for 10 week. The curcumin supplements will provide from Karen pharmaceutical and dietary supplements company, Tehran, Iran. Based on body mass index percentile, subjects will receive a weigh maintenance or a mild weight loss diet (maximum half a kilogram per month). Control group: Subjects in control group will receive placebo (1 per day) for 10 week. The placebo will provide from Karen pharmaceutical and dietary supplements company, Tehran, Iran. The placebo will completely similar in appearance with curcumin supplements. Based on body mass index percentile, subjects will receive a weigh maintenance or a mild weight loss diet (maximum half a kilogram per month). Weight. Timepoint: At the beginning of study- week 10. Method of measurement: Seca scale. Height. Timepoint: At the beginning of study- week 10. Method of measurement: Strip meter. Waist circumference. Timepoint: At the beginning of study- week 10. Method of measurement: Strip meter. Hip circumference. Timepoint: At the beginning of study- week 10. Method of measurement: Strip meter. Body mass index. Timepoint: At the beginning of study- week 10. Method of measurement: formula. Fasting blood sugar. Timepoint: At the beginning of study- week 10. Method of measurement: biochemical assessment. Fasting Insulin. Timepoint: At the beginning of study- week 10. Method of measurement: biochemical assessment. Homeostatic model assessment of insulin resistance. Timepoint: At the beginning of study- week 10. Method of measurement: formula. C-reactive protein. Timepoint: At the beginning of study- week 10. Method of measurement: biochemical assessment. Interleukin 6. Timepoint: At the beginning of study- week 10. Method of measurement: biochemical assessment. Chemerin. Timepoint: At the beginning of study- week 10. Method of measurement: biochemical assessment. Total Antioxidant Capacity. Timepoint: At the beginning of study- week 10. Method of measurement: biochemical assessment. Malondialdehyde. Timepoint: At the beginning of study- week 10. Method of measurement: biochemical assessment. Esfahan University of Medical Sciences Approved 2017-06-20 Ethics committee of Isfahan University of Medical Sciences Hezar jarib street, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)