Clinical Trial Protocol Iranian Registry of Clinical Trials

25 Sep 2021

Eﬀect of aerobic exercise and green tea supplementation on body composition, and cardio metabolic risk factors of overweight and obese women.

Protocol summary General information

Study aim Reason for update Assessing the eﬀect of aerobic exercise and green tea Acronym IRCT registration information supplementation on body composition, and cardio IRCT registration number: IRCT20150531022498N17 metabolic risk factors of overweight and obese women Registration date: 2018-02-07, 1396/11/18 Design Registration timing: retrospective In this research, 39 overweight and obese women will be select and randomly divide in to three equal groups including aerobic- group, aerobic combine with green tea Last update: 2018-02-07, 1396/11/18 consumption and control groups. Update count: 0 Registration date Settings and conduct 2018-02-07, 1396/11/18 The present study is a semi-experimental study on the women of city of Lasht-e Nesha . Aerobic training will be Registrant information conducting three time per week and green tea will be Name consuming on a daily basis. The study duration will be Ramin Shabani eight weeks. The level of fasting blood sugar, blood lipid, Name of organization / entity Rest heart rate, blood pressure and body composition Islamic Azad University will be measuring before and after the end of Country Iran (Islamic Republic of) interventions period Phone Participants/Inclusion and exclusion criteria +98 13 3375 2715 The woman age ranges of 22-34 years old have Email address overweight or obese not have cardiovascular or [email protected] orthopedic disorders No regular exercise Intervention groups Recruitment status Aerobic training group: eight weeks, three times per Recruitment complete Funding source week, each session consist of 80-90 min , with intensity 40- 80% target heart rate Aerobic training combine with green tea consumption: Aerobic training combine with Expected recruitment start date green tea consumption: eight weeks, three time training 2016-05-21, 1395/03/01 Expected recruitment end date (Similar to aerobic training group) combine with daily 2016-08-21, 1395/05/31 consumption of 33 mg green tea (After three main meal) Actual recruitment start date Control group: no intervention will be conducting. empty Main outcome variables Actual recruitment end date fasting blood sugar, blood lipid, Rest heart rate, blood empty pressure and body composition Trial completion date

1 empty Postal code ۴۱۴۷۶۵۴۹۱۹ Scientific title Approval date Effect of aerobic exercise and green tea supplementation 2016-09-18, 1395/06/28 on body composition, and cardio metabolic risk factors of Ethics committee reference number overweight and obese women. IR.IAU. RASHT.REC.1395.25 Public title Effect of aerobic exercise and green tea supplementation Health conditions studied in overweight and obese women. Purpose 1 Prevention Inclusion/Exclusion criteria Description of health condition studied Inclusion criteria: Overweight and obese women The woman age ranges of 22-34 years old have ICD-10 code overweight or obese not have cardiovascular or E66.0 orthopedic disorders No regular exercise ICD-10 code description Exclusion criteria: Obesity due to excess calories More than three session absence from the training Age Primary outcomes From 20 years old to 40 years old Gender Female 1 Description Phase Fasting Blood Glucose 2-3 Timepoint Groups that have been masked Before and after the end of interventions No information Method of measurement Sample size Serum levels using Glucose oxidase / per oxidase Target sample size: 39 method (mg/dl) Randomization (investigator's opinion) Randomized Randomization description 2 En Assigning samples using Simple random-lottery Description method Total cholesterol Blinding (investigator's opinion) Timepoint Not blinded Before and after the end of interventions Blinding description Method of measurement Placebo Serum levels using photo metric method (mg/dl) Not used Assignment Parallel 3 Other design features Description Low density cholesterol Secondary Ids Timepoint Before and after the end of interventions empty Method of measurement Serum levels using photo metric method (mg/dl) Ethics committees 4 1 Description Ethics committee High density cholesterol Name of ethics committee Timepoint Ethics Committee of Islamic Azad University Rasht Before and after the end of interventions Branch Method of measurement Street address Serum levels using photo metric method (mg/dl) Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht 5 City Rasht Description Province Triglyceride Guilan Timepoint

2 Before and after the end of interventions Recruitment centers Method of measurement Serum levels using photo metric method (mg/dl) 1 6 Recruitment center Name of recruitment center Description Lasht-Nesha city Rest heart rate Full name of responsible person Timepoint Hajar Amozadeh Before and after the end of interventions Street address Method of measurement Lasht-Nesha, Guilan, Iran By measuring the pulse City Lasht-Nesha 7 Province Guilan Description Postal code Blood pressure 9194147654 Timepoint Phone Before and after the end of interventions +98 13 3342 4080 Method of measurement Email Pressure device [email protected]

Secondary outcomes Sponsors / Funding sources

1 1 Description Sponsor Body composition Name of organization / entity Timepoint Islamic Azad University Before and after the end of interventions Full name of responsible person Method of measurement Ali delpasand Using weight, body mass index, waist to hip ratio and fat Street address percent Islamic Azad University Rasht Branch, Taleshan Bredge, Rasht Intervention groups City Rasht Province 1 Guilan Description Postal code Aerobic training group: eight weeks, three times per 4147654919 week, each session consist of 80-90 min , with intensity Phone 40- 80% target heart rate +98 13 3342 4080 Category Email Prevention [email protected] Grant name Grant code / Reference number 2 Is the source of funding the same sponsor Description organization/entity? Aerobic training combine with green tea Yes consumption:Aerobic training combine with green tea Title of funding source consumption: eight weeks, three time training (Similar to Islamic Azad University aerobic training group) combine with daily consumption Proportion provided by this source of 33 mg green tea (After three main meal) 100 Category Public or private sector Prevention Public Domestic or foreign origin Domestic 3 Category of foreign source of funding Description empty Control group: no intervention will be conducting. Country of origin Category Type of organization providing the funding Other Persons

3 Person responsible for general inquiries Email [email protected] Contact Name of organization / entity Person responsible for updating data Islamic Azad University Full name of responsible person Contact Hajar Amozadeh Name of organization / entity Position Islamic Azad University Master Full name of responsible person Latest degree Marzieh nazari Master Position Other areas of specialty/work Ph.D. student Physical education Latest degree Street address Master Islamic Azad University Rasht Branch, Taleshan Other areas of specialty/work Bridge, Rasht Physical education City Street address Rasht Islamic Azad University Rasht Branch, Taleshan Province Bridge, Rasht Guilan City Postal code Rasht 4147654119 Province Phone Guilan +98 13 3342 4080 Postal code Email 4147654919 [email protected] Phone +98 13 3342 4080 Email Person responsible for scientiﬁc [email protected] inquiries Sharing plan Contact Name of organization / entity Deidentiﬁed Individual Participant Data Set (IPD) Islamic Azad University Undecided - It is not yet known if there will be a plan to Full name of responsible person make this available Ramin shabani Study Protocol Position Undecided - It is not yet known if there will be a plan to Associate professor make this available Latest degree Statistical Analysis Plan Ph.D. Undecided - It is not yet known if there will be a plan to Other areas of specialty/work make this available physical education Informed Consent Form Street address Undecided - It is not yet known if there will be a plan to Islamic Azad University Rasht Branch, Taleshan make this available Bridge, Rasht Clinical Study Report City Undecided - It is not yet known if there will be a plan to Rasht make this available Province Analytic Code Guilan Undecided - It is not yet known if there will be a plan to Postal code make this available 41447654919 Data Dictionary Phone Undecided - It is not yet known if there will be a plan to +98 13 3375 2715 make this available