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IRCT20210103049933N2 IRCT 2021-05-24 Islamic Azad University The effects of curcumin supplementation along with pilates training in overweight and obese women The effects of curcumin supplementation along with pilates training on anthropometric indices, liver enzymes and lipid profile in overweight and obese women 2021-05-22 anticipated 60 Complete https://irct.ir/trial/53903 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: Assignment of people in each of the study groups (supplement, placebo, pilates training and supplement, pilates training and placebo) will be done by "Random allocation software" using classified randomized blocking method (block size: 4). In addition, in order to reduce selection bias error, allocation concealment will be used. This will be done by assigning unit codes (two codes A and B) to each person's capsules. In this way, 60 people will be randomly allocated to supplement (n = 15), placebo (n = 15), pilates training and supplement (15), pilates training and placebo (n = 15) groups. In fact, each person will receive a can containing code A or B, and eventually 30 people will receive cans containing code A and 30 people will receive cans containing code B. Also, 30 people in two groups will receive pilates training in addition to supplement or placebo, Blinding description: In the present study, the statistical analyst will be blinded to the study groups. Before starting the study, the cans containing the respective capsules will be coded by a person other than the researcher (this person will not aware of the details of the research) to A and B, so that the type of received capsules in each group will be blinded for researcher. Also, placebo and supplement capsules will be similar in terms of color, shape, size and taste. In addition, cans containing the supplement and placebo will be quite similar. 3 Overweight and obesity. Intervention 1: Intervention group:1) Supplement: one capsule 500 mg/d (450 mg of turmeric rhizome and 50 mg of turmeric extract) for 8 weeks. Intervention 2: Control group: one capsule 500 mg/d containing starch for 8 weeks. Intervention 3: Intervention group: 2) Pilates training (three times/week, 1 hour each time) and supplement one capsule 500 mg/d (450 mg of turmeric rhizome and 50 mg of turmeric extract) for 8 weeks. Intervention 4: Intervention group: 3) Pilates training (three times/week, 1 hour each time) and placebo (one capsule 500 mg/d containing starch) for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is The person's information will be confidential and the results will be as collective statistics
public zeynab porasgari
No.133, Mehregan Medical Building, Motahari St, Ramsar, Iran
Ramsar Iran (Islamic Republic of) ۴۶۹۱۸۴۶۹۴۰ +98 911 196 0775 porasgarizeynab@yahoo.com Islamic Azad University scientific Zeynab Porasgari
No.133, Mehregan Medical Building, Motahari St, Ramsar, Iran
Ramsar Iran (Islamic Republic of) ۴۶۹۱۸۴۶۹۴۰ +98 911 196 0775 porasgarizeynab@yahoo.com Islamic Azad University Iran (Islamic Republic of) Willingness to participate in the study Women between 20 to 50 years old Body mass index (BMI) between 25 to 35 (kg / m2) 20 years 50 years Female Reluctance of patients to participate in the study Use of other dietary supplements, probiotics and anti-inflammatory drugs Use of any antioxidant supplements in the last 3 months Use of immunosuppressive drugs Following of special diets Change of diet or decide to lose weight Pregnancy, lactation Smokers Menopause Having a history of diabetes, cancer, liver, kidney, thyroid and gastrointestinal diseases Having surgical operation to weight loss E66 Overweight and obesity Lifestyle Placebo Lifestyle Lifestyle Intervention group:1) Supplement: one capsule 500 mg/d (450 mg of turmeric rhizome and 50 mg of turmeric extract) for 8 weeks Control group: one capsule 500 mg/d containing starch for 8 weeks Intervention group: 2) Pilates training (three times/week, 1 hour each time) and supplement one capsule 500 mg/d (450 mg of turmeric rhizome and 50 mg of turmeric extract) for 8 weeks Intervention group: 3) Pilates training (three times/week, 1 hour each time) and placebo (one capsule 500 mg/d containing starch) for 8 weeks Weight. Timepoint: Before the intervention and 1 week after the end of intervention. Method of measurement: Seca scale. Body mass index. Timepoint: Before the intervention and 1 week after the end of intervention. Method of measurement: Weight divided by the square of height in meters (kg / m2). Waist circumference. Timepoint: Before the intervention and 1 week after the end of intervention. Method of measurement: Tape metre (cm). Hip circumference. Timepoint: Before the intervention and 1 week after the end of intervention. Method of measurement: Tape metre (cm). Lipid profile (HDL-c, LDL-c, TG, total cholesterol and VLDL). Timepoint: Before the intervention and 1 week after the end of intervention. Method of measurement: Colorimetric enzymatic method (Pars Azmun). Alanine transaminase, Aspartate transaminase and Gamma-glutamyltransferase. Timepoint: Before the intervention and 1 week after the end of intervention. Method of measurement: Colorimetric enzymatic method (Pars Azmun). Islamic Azad University Approved 2021-04-20 Research Ethics Committee of Sport Sciences Research Institute Velayat University Complex, Shahid Sohani St., Army Blvd, Imam Ali highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)