Assessing the effect aerobic and resistance training with saffron aqua extract on glutathione peroxidase and malondialdehyde in men with Type 2 Diabetes
Design
In this research, 36 men with Type 2 Diabetes voluntarily will be selected as the study population and randomly divide into six groups: Aerobic training , Resistance training, Resistance training combine with Saffron supplement, Aerobic training group combine with Saffron supplement and Control groups.
Settings and conduct
The present study is a semi-experimental study among the men with Type 2 Diabetes in Rasht. The subjects will participate in the exercise training program and saffron supplement for 8 weeks. Blood sampling is performed after 12 hours of fasting and before and after eight weeks of exercise training.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Have age ranges 35-48 years, not have regular exercise training during last year
Exclusion criteria: have cardiovascular and orthopedic disease.
Intervention groups
Resistance training group: eight weeks, three times per week with intensity 65-70% 1RM
Aerobic training group: eight weeks, three times per week with intensity 55-70 % Maximum heart rate
Resistance training combine with Saffron supplement: Similar to aerobic training group combine with daily consumption of 3 mg Saffron (before exercise training with 8 week)
Aerobic training group combine with Saffron supplement: Similar to aerobic training group combine with daily consumption of 3 mg Saffron (before exercise training with 8 week
Control group: consumption of daily 3 mg of saffron supplement as a placebo
Control group: Without intervention
Main outcome variables
glutathione peroxidase and malondialdehyde
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150531022498N21
Registration date:2018-04-19, 1397/01/30
Registration timing:retrospective
Last update:2018-04-19, 1397/01/30
Update count:0
Registration date
2018-04-19, 1397/01/30
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-19, 1395/01/31
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of aerobic and Resistance Training with Saffron Aqua Extract on Glutathione peroxidase and Malondialdehyde in Men with Type 2 Diabetes
Public title
The Effect of aerobic and Resistance Training with Saffron Aqua Extract in Men with Type 2
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Have age ranges 35-48 years with Type 2 Diabetes
Be man
No regular exercise
Exclusion criteria:
have cardiovascular and orthopedic disorders
Age
From 35 years old to 48 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Assigning samples using Simple random-lottery method
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University Rasht Branch
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2018-02-09, 1396/11/20
Ethics committee reference number
IR.IAU.RASHT.REC.1396.58
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Malondialdehyde
Timepoint
Before and after the end of interventions
Method of measurement
Serum level by ELISA method(n mol/ ml)
2
Description
Glutathione peroxidase
Timepoint
Before and after the end of interventions
Method of measurement
Serum level by ELISA method (U/l)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aerobic training group: eight weeks, three times per week with intensity 55-70 % Maximum heart rate
Category
Prevention
2
Description
Intervention group: Resistance training group: eight weeks, three times per week with intensity 65-70% 1RM
Category
Prevention
3
Description
Intervention group: Aerobic training combine with Saffron supplement: Similar to aerobic training group combine with daily consumption of 3 mg Saffron (before exercise training with 8 week)
Category
Prevention
4
Description
Intervention group: Resistance training combine with Saffron supplement: Similar to resistance training group combine with Saffron supplement
Category
Prevention
5
Description
Control group: consumption of daily 3 mg of saffron supplement as a placebo
Category
Prevention
6
Description
Control group: Without intervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital in Rasht
Full name of responsible person
Vahid Aghajani
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
marzieh.nazari.v@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Delpasand
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 3308
Email
shabani_msn@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Vahid Aghajani
Position
MA
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 3308
Email
marzieh.nazari.v@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ramin Shabani
Position
Associate professore
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 3308
Email
shabani_msn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marzieh Nazari
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 3308
Email
marzieh.nazari.v@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available