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IRCT20210103049933N1 IRCT 2021-05-19 Islamic Azad University The effects of aerobic training along with spirulina supplementation in women with overweight and obesity The effects of aerobic training along with spirulina supplementation on markers of hepatic, cardiovascular, lipid profile and anthropometric indices in women with overweight and obesity 2021-05-22 anticipated 40 Complete https://irct.ir/trial/53926 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of people in each of the study groups (supplement, placebo, aerobic training and supplement, aerobic 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 = 10), placebo (n = 10), aerobic training and supplement (10), aerobic training and placebo (n = 10) groups. In fact, each person will receive a can containing code A or B, and eventually 20 people will receive cans containing code A and 30 people will receive cans containing code B. Also, 20 people in two groups will receive aerobic 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 group1: Three capsules 500 mg/d of spirulina after each meal for 8 weeks (Made by the German Rocket company ). Intervention 2: Control group: Three capsules 500 mg/d containing starch after each meal for 8 weeks (Made by the Faculty of Pharmacy, Mazandaran University of Medical Sciences). Intervention 3: Intervention group 2: Aerobic training (three times/week, 1 hour each time) and three capsules 500 mg/d of spirulina after each meal for 8 weeks (Made by the German Rocket company ). Intervention 4: Intervention group 3: Aerobic training (three times/week, 1 hour each time) and placebo (three capsules 500 mg/d containing starch) after each meal for 8 weeks (Made by the Faculty of Pharmacy, Mazandaran University of Medical Sciences). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in 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 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 Pregnancy, lactation Smokers Menopause Having a history of diabetes, cancer, liver, kidney, thyroid and gastrointestinal diseases E66 Overweight and obesity Lifestyle Placebo Lifestyle Lifestyle Intervention group1: Three capsules 500 mg/d of spirulina after each meal for 8 weeks (Made by the German Rocket company ) Control group: Three capsules 500 mg/d containing starch after each meal for 8 weeks (Made by the Faculty of Pharmacy, Mazandaran University of Medical Sciences) Intervention group 2: Aerobic training (three times/week, 1 hour each time) and three capsules 500 mg/d of spirulina after each meal for 8 weeks (Made by the German Rocket company ) Intervention group 3: Aerobic training (three times/week, 1 hour each time) and placebo (three capsules 500 mg/d containing starch) after each meal for 8 weeks (Made by the Faculty of Pharmacy, Mazandaran University of Medical Sciences) Weight. Timepoint: Before and after the intervention. Method of measurement: Seca scale. Body mass index. Timepoint: Before and after the intervention. Method of measurement: Weight divided by the square of height in meters (kg / m2). Waist and hip circumference. Timepoint: Before and after the intervention. Method of measurement: Tape metre (cm). Liver enzymes (alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase). Timepoint: Before and after the intervention. Method of measurement: Colorimetric enzymatic method (Pars Azmun). Lipid profile (HDL-c, LDL-c, TG, total cholesterol and VLDL). Timepoint: Before and after the intervention. Method of measurement: Colorimetric enzymatic method (Pars Azmun). Serum homocysteine. Timepoint: Before and after the intervention. Method of measurement: ELISA. Serum levels of C-reactive protein. Timepoint: Before and after the intervention. Method of measurement: ELISA. Islamic Azad University Islamic Azad University Islamic Azad University Approved 2021-04-20 Ethics Committee of Islamic Azad University of Tehran Velayat University Complex, Shahid Sohani St., Army Blvd, Imam Ali highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)