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IRCT20190731044398N4 IRCT 2020-07-25 Vice Chancellor For Research, Ferdowsi University Effects of Saffron (Crocus sativus L.) supplementation and Combined Training in obese men with T2DM Effects of Saffron (Crocus sativus L.) supplementation and Combined Training on Physiological Regulators in obese men with T2DM 2020-05-30 anticipated 60 Complete https://irct.ir/trial/49808 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: In order to randomize, simple randomization method with random number Table method was used. This table contains a bunch of numbers that are randomly drawn in the form of a table without a specific pattern and order. The numbers directions(Left, right, up, down) were first determined by the researcher to read the numbers and then the numbers were considered for different research groups. In the next step, the researcher randomly placed on one of the numbers and moved in the present direction and recorded the numbers for that direction in the target group, Blinding description: In this research, participants are unaware of the group assigned to themselves and other participants. experts in laboratory analysis are also unaware of the type of intervention and the participating groups. N/A Condition 1: type 2 diabetes. Condition 2: obesity. Intervention 1: Intervention group: The training group performed 12 weeks and each week 3 sessions of combined training (Resistance training, Aerobic training). Resistance training (Three sets / six exercises / 60-90-second rest between each set/ 90-120-second rest between each exercise) which contained leg press, bench press, leg extension, lat pulldown, lying leg curl, and shoulder press. the aerobic training protocol was 1×10 minutes exercise with one minute active rest between the sets. Intervention 2: Intervention group: The saffron group consumed one pill of 100 mg of saffron for 12 weeks. Intervention 3: Intervention group: the saffron + training group performed a combined training program (Resistance training, Aerobic training) for 12 weeks and 3 sessions per week and consumed one pill of 100 mg of saffron daily. Resistance training (Three sets / six exercises / 60-90-second rest between each set/ 90-120-second rest between each exercise) which contained leg press, bench press, leg extension, lat pulldown, lying leg curl, and shoulder press. the aerobic training protocol was 1×10 minutes exercise with one minute active rest between the sets. Intervention 4: Control group: The control group did not perform combined training and did not consume saffron. Yes - There is a plan to make this available What will be shared: Publication of protocol study in form of the article and also data publication in the original article. The total potential data can be shared after unidentifiable subjects. When: 6 months after the publication of results To whom: All researchers who have access to clinical trials databases. Conditions: The only way for using the data is after the publication of the article in the indexed ISI journal. Where to obtain: Via database websites such as PubMed and google scholar and via email address: b.hooshmand.m@gmail.com How to obtain: The original article reaches the requestor by email within a maximum of one week. Comments:
public amir rashidlamir
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177948974 +98 51 3880 5000 amir.rashidlamir@um.ac.ir Ferdowsi University of Mashhad scientific amir rashidlamir
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177948974 +98 51 3880 5000 amir.rashidlamir@um.ac.ir Ferdowsi University of Mashhad Iran (Islamic Republic of) age 30-50 years BMI > 30 kg/m2 fasting blood glucose ≥ 126 mg/dL HbA1C ≥ 6.5% 30 years 50 years Male use insulin having cardiovascular diseases, musculoskeletal disorders, liver disease, kidney disease, and thyroid dysfunction having regular physical activity in the past year Not taking dietary supplements Sensitivity to saffron E11 E66 Non-insulin-dependent diabetes mellitus obesity Prevention Prevention Prevention Other Intervention group: The training group performed 12 weeks and each week 3 sessions of combined training (Resistance training, Aerobic training). Resistance training (Three sets / six exercises / 60-90-second rest between each set/ 90-120-second rest between each exercise) which contained leg press, bench press, leg extension, lat pulldown, lying leg curl, and shoulder press. the aerobic training protocol was 1×10 minutes exercise with one minute active rest between the sets. Intervention group: The saffron group consumed one pill of 100 mg of saffron for 12 weeks. Intervention group: the saffron + training group performed a combined training program (Resistance training, Aerobic training) for 12 weeks and 3 sessions per week and consumed one pill of 100 mg of saffron daily. Resistance training (Three sets / six exercises / 60-90-second rest between each set/ 90-120-second rest between each exercise) which contained leg press, bench press, leg extension, lat pulldown, lying leg curl, and shoulder press. the aerobic training protocol was 1×10 minutes exercise with one minute active rest between the sets. Control group: The control group did not perform combined training and did not consume saffron. Fasting insulin. Timepoint: Before and after intervention. Method of measurement: Autoanalyzer kit. Serum levels of testosterone. Timepoint: Before and after intervention. Method of measurement: Blood sampling and using ELISA method. Serum levels of Nitric oxide. Timepoint: Before and after intervention. Method of measurement: Blood sampling and using ELISA method. Serum levels of hs-CRP. Timepoint: Before and after intervention. Method of measurement: Blood sampling and using ELISA method. Serum levels of TNF-α. Timepoint: Before and after intervention. Method of measurement: Blood sampling and using ELISA method. Serum levels of IL-6. Timepoint: Before and after intervention. Method of measurement: Blood sampling and using ELISA method. Serum levels of IL-10. Timepoint: Before and after intervention. Method of measurement: Blood sampling and using ELISA method. Serum levels of adiponectin. Timepoint: Before and after intervention. Method of measurement: Blood sampling and using ELISA method. Serum levels of leptin. Timepoint: Before and after intervention. Method of measurement: Blood sampling and using ELISA method. Serum levels of Chemerin. Timepoint: Before and after intervention. Method of measurement: Blood sampling and using ELISA method. Fat mass. Timepoint: Before and after intervention. Method of measurement: bioelectrical impedance device. Fat free mass. Timepoint: Before and after intervention. Method of measurement: bioelectrical impedance device. Dietary intake. Timepoint: Before and after intervention. Method of measurement: Food record questionnaire. Vice Chancellor For Research, Ferdowsi University Approved 2019-11-13 Ethics committee of Ferdowsi University of Mashhad Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)