The effect of 8 weeks HIIT and resistance exercises and consumption of flaxseed oil on some parameters of oxidative stress (cat and sod) in women with diabetes
Determining the effect of 8 weeks of HIIT and resistance exercises and consumption of flaxseed oil on some parameters of oxidative stress (cat and sod) in women with diabetes
Design
Clinical trial with control group, with parallel groups, randomized, on 60 patients. Randomization by the method of equal blocks (15 blocks of 4) in which a number of intervention people and a number of comparison people are included in each block.
Settings and conduct
By referring to Hamedan Ba'ath Hospital, eligible people were identified and placed in the intervention groups using equal blocks randomization (15 blocks of 4). Then, people will go to the sports club for training intervention and perform exercises and supplements for 8 weeks. And before and 24 hours after exercise interventions, blood samples are taken from people to be measured in the laboratory.
Participants/Inclusion and exclusion criteria
Entry requirements: suffering from diabetes
Conditions of non-entry: inability to practice
Intervention groups
Exercises and supplements group: In the exercises group, the samples are subjected to high-intensity and resistance intermittent exercises, and the supplement group consumes flaxseed oil. The control group is not subjected to any intervention.
Main outcome variables
diabetes, some antioxidant factors (catalase and superoxide dismutase)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221120056548N3
Registration date:2023-02-25, 1401/12/06
Registration timing:prospective
Last update:2023-02-25, 1401/12/06
Update count:0
Registration date
2023-02-25, 1401/12/06
Registrant information
Name
Saeid Shamlou kazemi
Name of organization / entity
Bu-Ali Sina university
Country
Iran (Islamic Republic of)
Phone
+98 912 859 7297
Email address
saeidshamlou9092@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-28, 1401/12/09
Expected recruitment end date
2023-03-05, 1401/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks HIIT and resistance exercises and consumption of flaxseed oil on some parameters of oxidative stress (cat and sod) in women with diabetes
Public title
The effect of exercise and consumption of flaxseed oil on diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having diabetes
Exclusion criteria:
History of cardiovascular disease
Age
From 35 years old to 45 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
In this randomization, the method of equal blocks (15 blocks of 4) was used, in which a number of intervention people and a number of comparison people are included in each block, and we assigned them to different groups. The method and tool of block random sequence generation has been done using https://www.sealedenvelope.com/simple-randomiser/v1/lists.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sport Sciences Research Institute
Street address
Fifth Alley, Mir Emad Ave., Ostad Motahari Ave
City
Tehran
Province
Tehran
Postal code
1474674646
Approval date
2022-12-31, 1401/10/10
Ethics committee reference number
IR.SSRI.REC.1401.1870
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
The percentage of people whose blood sugar levels have decreased.
Timepoint
Blood sugar measurement before and after the intervention
Method of measurement
By measuring blood sugar in the laboratory
Secondary outcomes
1
Description
The percentage of people in whom the level of antioxidants catalase and superoxide dismutase increased.
Timepoint
Before and after interventions
Method of measurement
Using ELISA method and Zelbio kit made in Germany
Intervention groups
1
Description
Intervention group: Resistance training includes: resistance training by ballistic method and three sessions are held every week for 8 weeks. Each session started with a 15-minute warm-up including soft running, stretching and 3 sets of 5 repetitions of squat jumps without weights and jumping up and forwards without weights. Each session lasted approximately 30 to 40 minutes. 2 minutes rest between each set and 4 minutes rest between each movement. Movements include 10 throws of a medicine ball of 3 kg from the front of the chest, double leg jump from a bent position with a pause between each movement while carrying a weight of one kilogram in each hand, jumping up from a bent position with a pause between each movement and carrying the weight. One kilogram in each hand would be 10 repetitions of plantar flexion at 30% maximal effort and 10 jump squats, starting with the knee bent at 90 degrees at 30% maximal effort. HIIT training includes: The training program of the HIIT group will include periods of 60 seconds of maximal running (85-95% heart rate reserve (HRR)) followed by 60 seconds of low-intensity running (55-60% HRR). Subjects first week 6 times, 8 times in the second week, 10 times in the third to eighth week. Flaxseed oil consumption: in the herbal supplement group, Barij flaxseed oil capsules were used and each subject was given one capsule daily. It can be consumed before lunch. The consumption period is eight weeks and every day.
Category
Treatment - Other
2
Description
Control group: This group is not subject to any exercise intervention or supplement consumption.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
saeid shamlou kazemi
Street address
Shahid Beheshti Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3264 0020
Email
saeidshamlou9092@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Danesh Alborz University
Full name of responsible person
Saeid Shamlou Kazemi
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Danesh Alborz University
Proportion provided by this source
10
Public or private sector
Private
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
Bu-Ali Sina University
Full name of responsible person
Saeid shamlou kazemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh AVE
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Saeid shamlou kazemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh AVE
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Saeid shamlou kazemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh AVE
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
If the intellectual rights are preserved, the data can be sent to the researchers.
From where data/document is obtainable
Email address: saeidshamlou9092@gmail.com
What processes are involved for a request to access data/document