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IRCT20140415017288N7 IRCT 2021-03-06 Islamic Azad University Effect of Exercise and Spirulina on Elderly Men The Effect of Aerobic Training with Spirulina Supplementation on Mitochondrial-Derived Peptides, Inflammatory factors and Heart damage in Overweight Elderly Men 2021-04-09 anticipated 40 Complete https://irct.ir/trial/54708 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: In this research, subjects are selected Simple randomization by random allocation rule. After determining the sample size, they will be equally divided into five groups (1- Control, 2- Overweight, 3- Overweight + Exercise, 4- Overweight + Spirulina and 5- Overweight + Exercise + Spirulina). Using the lottery method, the names of the subjects are written on separate papers and placed in a container, then the names of the subjects are randomly taken out and placed in the intervention groups or placebo, respectively, Blinding description: The Overweight + Spirulina and Overweight + Exercise + Spirulina patients receive Spirulina (1000 mg/day), two capsules orally of 500 mg twice daily before breakfast and dinner for 8 weeks. Control, Overweight and Overweight + Exercise groups receive placebo in the same pharmacological presentation. Starch is used as placebo. 3 overweight elderly men. Intervention 1: Control group: in this group we have not any intervention during 8 weeks, and will consider this group as placebo. Intervention 2: Intervention group: Training group (in this group for eight week, three session/weeks, the training start with 10 min warming and then 40 min training with 65% Peak heart rate, which in the final weeks reaches 80% of the heart rate). Intervention 3: Intervention group: Spirulina supplementation group (in this group eat 1000 mg of spirulina supplementation for eight weeks Twice a day before breakfast and dinner). Intervention 4: Intervention group: Training+spirulina supplementation group (In this group the Simultaneous intervention, training and spirulina supplementation, will treat with the same protocol that describe at the previous part). Yes - There is a plan to make this available What will be shared: The report is submitted to the research department of the university. Also published as a paper. When: Since 2021 To whom: All researchers Conditions: Citing references Where to obtain: Scientific bases and Ayatollah Amoli Branch, Islamic Azad University, amol, Iran How to obtain: Maximum one week Comments:
public Ahmad Abdi
Ayatollah Amoli Branch, Islamic Azad University
Amol Iran (Islamic Republic of) 678 +98 11 4321 7124 a.abdi@iauamol.ac.ir Islamic Azad University scientific Alireza Barari
Ayatollah Amoli Branch, Islamic Azad University
Amol Iran (Islamic Republic of) 678 +98 11 4321 7126 alireza54.barari@gmail.com Islamic Azad University Iran (Islamic Republic of) Age range in the range of 50-65 years BMI more than 25 kg per square meter Inactive lifestyle (exercise less than 1 hour per week) Do not use the drug in 6 months No person or family has Covid disease 19 Satisfaction to participate in the study 50 years 65 years Male Take supplements and practice before starting the protocol Detection of other underlying diseases during the implementation of the protocol, such as cardiopulmonary problems and musculoskeletal disorders during exercise that prevent the performance of the activity Covid 19 disease E66.3 Overweight Placebo Treatment - Other Treatment - Other Treatment - Other Control group: in this group we have not any intervention during 8 weeks, and will consider this group as placebo. Intervention group: Training group (in this group for eight week, three session/weeks, the training start with 10 min warming and then 40 min training with 65% Peak heart rate, which in the final weeks reaches 80% of the heart rate). Intervention group: Spirulina supplementation group (in this group eat 1000 mg of spirulina supplementation for eight weeks Twice a day before breakfast and dinner). Intervention group: Training+spirulina supplementation group (In this group the Simultaneous intervention, training and spirulina supplementation, will treat with the same protocol that describe at the previous part). Effect of aerobic training and spirulina supplementation on Humanin. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on mitochondrial ORF of the 12S rRNA type-c (MOTS-c). Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on Transforming growth factor beta 1 (TGF-β1). Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on Tumor necrosis factor alpha (TNF-α). Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on Growth Differentiation Factor 15 (GDF15). Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on N-terminal pro-brain natriuretic peptide (NTproBNP). Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1). Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on E-selectin. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on Ghrelin. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on Nesfatin-1. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on Obstatin. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on YY peptide. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on sICAM-1. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on sVCAM-1. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on E-selectin. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Effect of aerobic training and spirulina supplementation on endothelin-1. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods. Islamic Azad University Approved 2021-03-01 Ethics Committee of Islamic Azad University - Marvdasht Branch 3 km of Marvdasht-Persepolis Boulevard, Islamic Azad University, Marvdasht Branch Marvdasht Fars Iran (Islamic Republic of) Approved 2021-12-26 Ethics Committee of Islamic Azad University - Marvdasht Branch 3 km of Marvdasht-Persepolis Boulevard, Islamic Azad University, Marvdasht Branch Marvdasht Fars Iran (Islamic Republic of)