The effect of 4 weeks high-intensity interval training (HIIT) with Spirulina supplementation on serum total antioxidant capacity (TAC) and Malondialdehyde (MDA) in women with type 2 diabetes (T2D)
evaluate the effect of 4 weeks high-intensity interval training (HIIT) with Spirulina supplementation on serum total antioxidant capacity (TAC) and Malondialdehyde (MDA) in women with type 2 diabetes
Design
This study is a randomized, controlled clinical trial design with parallel group design.
Settings and conduct
The statistical population of this study is women with type 2 diabetes mellitus. 60 of these people are selected based on inclusion and exclusion criteria the research. After completion of the consent form, the anthropometric and blood glucose characteristics of the subjects were recorded and based on the blood glucose of the subjects, the subjects were divided into four groups: 1_ hiit + spirulina (15), 2_ hiit (15 subjects), 3_ supplements (15 people), 4_ controls (15 people). Blood sampling is performed in two steps, one day before the training sessions and 48 hours after the end of the training. Spirulina supplementation is 2 grams per day for supplemental groups. Research variables will be measured after 4 weeks of intervention. The results are analyzed using the appropriate statistical method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No Appearance and clinical signs of cardiovascular disease
Intervention groups
1. HIIT group : Three sessions per week for 4 weeks
2. Spirulina supplements: Take 2 grams of spirulina daily
3. Supplement and Exercise Group: Two grams of spirulina supplement per day and three sessions of exercise per week for 4 weeks
3. Control group: no exercise and supplement
Main outcome variables
serum levels of malondialdehyde and total antioxidant capacity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180711040425N1
Registration date:2018-10-10, 1397/07/18
Registration timing:retrospective
Last update:2018-10-10, 1397/07/18
Update count:0
Registration date
2018-10-10, 1397/07/18
Registrant information
Name
Saeedeh Khodadadi
Name of organization / entity
Shahrood university of technology
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 2204
Email address
ss.kk1159@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 4 weeks high-intensity interval training (HIIT) with Spirulina supplementation on serum total antioxidant capacity (TAC) and Malondialdehyde (MDA) in women with type 2 diabetes (T2D)
Public title
The effect of exercise intensity and supplementation on diabetes
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
T2D detection < 10 years ago
Ages 40 to 65 years old
No dependency to insulin
The use of commonly used diabetes medications, such as metformin and glenalbelamine
Exclusion criteria:
Cardiovascular disease
Coronary artery disease
Atrial fibrillation
High blood pressure
Congenital heart disease
Retinopathy
Neuropathy
Body mass index 35
Ischemia in echocardiography
Disability that causes difficulty in practice.
Age
From 40 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate participants to research groups, a computer inventory of random numbers using a computer software (Random Allocation Software 2.0) will first be created by one of the research colleagues.Allocate participants by one of the research team members that is not related to the participants is done by block randomization with 4 blocks within the experimental (training) and control groups. Participants will be classified into 4 groups using randomized block method, depending on their blood glucose variables. The limitation of this method is the prediction of final allocation, which is the solution of random use of blocks of different sizes.
Assignment sequences are hidden by the envelopes encoded in the order numbered, and the letter envelopes are opened only after all the initial and initial evaluations of the participants have been made.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research of Shahroud University of Medical Sciences.
Street address
Shahrood University of Technology, Haft-e-Tir Square
City
shahrood
Province
Semnan
Postal code
3619995161
Approval date
2018-07-02, 1397/04/11
Ethics committee reference number
IR.SHMU.REC.1397.069
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
serum levels of Malondialdehyde in women with type 2 diabetes
Timepoint
One day before the session begins and 48 hours after the end of the exercise
Method of measurement
The MDA level measurement will be performed by ELISA, using a commercially available chemical calorimetry laboratory kit (MDA test kit; ZellBio GmbH, Ulm, Germany).
2
Description
Serum Total Antioxidant Capacity in women with type 2 diabetes
Timepoint
One day before the session begins and 48 hours after the end of the exercise
Method of measurement
The serum level of antioxidant total capacity will be measured by ELISA and using a commercial kit under the manufacturer's protocols (ZellBio GmbH, Germany).
Secondary outcomes
empty
Intervention groups
1
Description
first Intervention group: The training group consisted of three sessions per week of high intensity interval training for 4 weeks. Training sessions consisted of 45 minutes walk or running on a treadmill. Each session is divided into 10 minutes of warming up with an intensity 50-70% HRR, 10 minutes of cooling down with an intensity 50-70% HRR and 25 minutes of high intensity interval training ( HIIT The training section consists of 4 4-minute sections, with an intensity of 85 to 95% HRR and 3-minute rest periods, with an intensity of 50-70% HRR).
Category
Other
2
Description
Spirulina 2 grams daily, including 4 pills 500 mg before meals, for 4 weeks. This supplement is made by Qeshm algae and contains spirulina pure green algae. spirulina is a blue-green wonder aglae. It is the most powerful food existing in nature with 60% protein content and 18 amino acids.
Category
Other
3
Description
Third intervention group: Exercise + supplement group consisting of three sessions per week of high intensity interval training for 4 weeks and 2 grams of supplementation of spirulina per day for 4 weeks
Category
Other
4
Description
fourth intervention group: control group, No Spirulina supplement and no exercise
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrood diabetes association
Full name of responsible person
Shahrood diabetes association
Street address
Imam street
City
shahrood
Province
Semnan
Postal code
1355936735
Phone
+98 23 3234 0000
Email
ss.kk1159@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Technology
Full name of responsible person
Ali Hasani
Street address
Shahrood University of Technology, Haft-e-Tir Square
City
shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
hassani_3@shahrood.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Technology
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
Shahroud University of Technology
Full name of responsible person
saeedeh khodadadi
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Others
Street address
Shahroud Industrial University, Haft-e Tir Square
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
ss.kk1159@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrood university of technology
Full name of responsible person
Saeedeh Khodadadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
Shahrood
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
ss.kk1159@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Technology
Full name of responsible person
saeedeh khodadadi
Position
Student Master
Latest degree
Master
Other areas of specialty/work
Others
Street address
Shahrood University of Technology, Haft-e-Tir Square
City
shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
ss.kk1159@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The informed consent form will be available to others without mentioning the names of the participants. Details of the study process are also provided in detail in the file format.
When the data will become available and for how long
Start of the 6 month period after the research
To whom data/document is available
For university students and students in research related fields
Under which criteria data/document could be used
There are no specific conditions to provide such information.
From where data/document is obtainable
Saeedeh Khodadadi
What processes are involved for a request to access data/document
Send message to the person responsible for providing the data