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IRCT20160813029322N4 IRCT 2021-11-09 Zahedan University of Medical Sciences The effect of exercise and spirulina supplementation on the Asprosin hormone in overweight men Determining the effect of 8 weeks of resistance training and spirulina supplementation on levels of asprosin, Glucose, lipid profile and some body composition indices in overweight men 2021-08-23 anticipated 60 Complete https://irct.ir/trial/56245 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Out of all the population, a number of 60 overweight men will be selected using G-Power software. Individuals will be divided into four groups by the permuted block method with blocks size 4 as A: placebo, B: spirulina with training, C: training with placebo, and D: spirulina, Blinding description: The present study is a single blind, clinical trial study. It is single blind in spirulina and placebo groups. The subjects will study the research protocol in the first session. The supplement and placebo will be in the same capsules. The capsules will be distributed among the participants. Only the researcher knows the contents of the capsules. N/A Overweight and obesity. Intervention 1: Intervention group 1: Training with spirulina: Spirulina group will take two 500 mg spirulina capsules daily (morning and evening) for eight weeks. Rayhaneh Pharmaceutical Company of Isfahan will provide Spirulina supplement. Resistance training will be implemented for eight weeks, 3 sessions each week, and in 12 movements with 1, 2, 3, and 4-minute rest intervals, and 40, 60, 75, and 90 percent of a maximum repetition, using a flexible scheduling pattern, and an additional principle. Exercises will be performed in a gym in Zahedan. Intervention 2: Intervention group 2: spirulina. Spirulina group will take two 500 mg spirulina capsules daily (morning and evening) for eight weeks. Rayhaneh Pharmaceutical Company of Isfahan will provide Spirulina supplement. Intervention 3: Control group 1: Training With placebo. The placebo group will take two 500 mg capsules of starch daily for eight weeks. The placebo will be provided by Reyhaneh Pharmaceutical Company of Isfahan. Resistance training will be implemented for eight weeks, 3 sessions each week, and in 12 movements with 1, 2, 3, and 4-minute rest intervals, and 40, 60, 75, and 90 percent of a maximum repetition, using a flexible scheduling pattern, and an additional principle. Exercises will be performed in a gym in Zahedan. Intervention 4: Control group 2: Placebo. The placebo group will take two 500 mg capsules of starch daily for eight weeks. The placebo will be provided by Reyhaneh Pharmaceutical Company of Isfahan. Yes - There is a plan to make this available What will be shared: All data including: (IPD), study protocol, statistical analysis map, informed consent form, clinical study report and data dictionary will be published upon completion of the study. Participants' identities will not be released. When: Data will be available immediately upon completion of the project. It will probably be released in 1401. To whom: For researchers of academic and scientific institutions Conditions: For the development of related sciences Where to obtain: Refer to Zahedan University of Medical Sciences by letter How to obtain: Submit a valid letter from the scientific centres Comments:
public Hossein Nakhaei
Main campus, Dr. Hassabi Square
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5765 hossiennakhaie@yahoo.com Zahedan University of Medical Sciences scientific Hossein Nakhaei
Main campus, Dr. Hessabi Square
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5765 hossiennakhaie@yahoo.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Aged between 50-30 years old General physical and mental health Body mass index (BMI) more than 25 kg / m 2 30 years 50 years Male If the participant has exercised regularly during 6 months before the start of training sessions If the participant has suffers from cardiovascular diseases If the participant has suffers from diabetes disease If the participant has suffers from hormonal disorders disease If the participant has suffers from kidney disease If the participant has suffers from liver disease If the participant is a smoker If the participant has recently had any surgery or medical interventions E66 Overweight and obesity Rehabilitation Treatment - Drugs Rehabilitation Placebo Intervention group 1: Training with spirulina: Spirulina group will take two 500 mg spirulina capsules daily (morning and evening) for eight weeks. Rayhaneh Pharmaceutical Company of Isfahan will provide Spirulina supplement. Resistance training will be implemented for eight weeks, 3 sessions each week, and in 12 movements with 1, 2, 3, and 4-minute rest intervals, and 40, 60, 75, and 90 percent of a maximum repetition, using a flexible scheduling pattern, and an additional principle. Exercises will be performed in a gym in Zahedan. Intervention group 2: spirulina. Spirulina group will take two 500 mg spirulina capsules daily (morning and evening) for eight weeks. Rayhaneh Pharmaceutical Company of Isfahan will provide Spirulina supplement. Control group 1: Training With placebo. The placebo group will take two 500 mg capsules of starch daily for eight weeks. The placebo will be provided by Reyhaneh Pharmaceutical Company of Isfahan. Resistance training will be implemented for eight weeks, 3 sessions each week, and in 12 movements with 1, 2, 3, and 4-minute rest intervals, and 40, 60, 75, and 90 percent of a maximum repetition, using a flexible scheduling pattern, and an additional principle. Exercises will be performed in a gym in Zahedan. Control group 2: Placebo. The placebo group will take two 500 mg capsules of starch daily for eight weeks. The placebo will be provided by Reyhaneh Pharmaceutical Company of Isfahan. Asprosin. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Plasma Asprosin levels were measured using an ELISA kit (Zell Bio Co made in Germany with a sensitivity of 0.05 ng/m), and ELISA-by-ELISA Reader (US lotion model). Glucose. Timepoint: Before the intervention and two months after the intervention. Method of measurement: ParsAzmon Kit (mg/dl). Triglyceride. Timepoint: Before the intervention and two months after the intervention. Method of measurement: ParsAzmon Kit (mg/dl). Cholesterol. Timepoint: Before the intervention and two months after the intervention. Method of measurement: ParsAzmon Kit (mg/dl). High Density Lipoprotein. Timepoint: Before the intervention and two months after the intervention. Method of measurement: ParsAzmon Kit (mg/dl). Low Density Lipoprotein. Timepoint: Before the intervention and two months after the intervention. Method of measurement: ParsAzmon Kit (mg/dl). Least body mass. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Body composition analyzer, model IOI 353, made by Jawon Medical, South Korea. Lean body mass. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Body composition analyzer, model IOI 353, made by Jawon Medical, South Korea. Waist to height ratio. Timepoint: Before the intervention and two months after the intervention. Method of measurement: Height will be measured with Sahand Company's height meter and Waist circumference will be measured with a Tape meter (made in Iran). Zahedan University of Medical Sciences Approved 2021-05-02 university/regional research Ethics committee Zahedan University of medical sciences Medical Sciences Campus- Dr. Hesabi Square- Zahedan City- Sistan and Baluchestan Province Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)