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The effect of eight weeks of home aerobic exercise and turmeric supplementation on anthropometric indices, glycemic status, lipid profile and quality of life in middle-aged women with type 2 diabetes during Covid -19 quarantine

Protocol summary

Study aim
Determining the simultaneous and separate effects of 8 weeks of aerobic exercise at home and turmeric supplementation on anthropometric indices, glycemic status, lipid profile and quality of life in middle-aged women with type 2 diabetes in Kermanshah during covid-19 quarantine in 1400
Design
The clinical trial has a control group with parallel groups. Randomly on 40 patients, to analyze the data, first the normal distribution of data will be checked using Shapiro-Wilk test, if the normal distribution of data is confirmed by two-way analysis of variance test and if the natural distribution of data is not, the test Kruskal-Wallis nonparametric will be used to evaluate the intergroup factor and Wilcoxon nonparametric test will be used to evaluate the intragroup factor using SPSS software version 24 at a significance level of P˂0.05.
Settings and conduct
Aerobic exercise for 8 weeks will be done online and at home under the supervision of a specialist doctor and sports specialist. Tests and sampling are performed in the laboratory and under the supervision of a specialist.
Participants/Inclusion and exclusion criteria
Non-insulin type 2 diabetes, HbA1C above 6, TG above 150 mg / dL and LDL above 100 mg / dL, no antioxidants, multivitamin and polyphenol supplements in the last three months, index Overweight body mass (25 to 29.99 kg / m2)
Intervention groups
Subjects will be divided into four groups: aerobic exercise (n = 10), turmeric supplement group (n = 10), aerobic exercise + turmeric supplement (n = 10) and control group (n = 10).
Main outcome variables
anthropometric indices, glycemic status, lipid profile and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201129049524N1
Registration date: 2021-05-26, 1400/03/05
Registration timing: prospective

Last update: 2021-05-26, 1400/03/05
Update count: 0
Registration date
2021-05-26, 1400/03/05
Registrant information
Name
Mahsa Ahmady darmian
Name of organization / entity
Razi university
Country
Iran (Islamic Republic of)
Phone
+98 83 3426 6383
Email address
m.ahmady@stu.razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-15, 1400/03/25
Expected recruitment end date
2021-07-16, 1400/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of home aerobic exercise and turmeric supplementation on anthropometric indices, glycemic status, lipid profile and quality of life in middle-aged women with type 2 diabetes during Covid -19 quarantine
Public title
The effect of aerobic exercise at home and turmeric supplementation in type 2 diabetes during Covid -19 quarantine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Non-insulin type 2 diabetes HbA1C above 6 TG above 150 mg / dL LDL above 100 mg / dL Do not take antioxidants, multivitamin supplements and polyphenols in the last three months Overweight body mass index (25 to 29.99 kg / m2)
Exclusion criteria:
Change in the amount and type of medication used Physical activity and diet during the study period Fasting blood sugar greater than 200 mg / dL LDL greater than 160 mg / dL Acute heart disease, kidney, liver and thyroid failure Severe gastrointestinal diseases and gastric ulcer Gallstones Pregnancy or breastfeeding
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: 40
Randomization (investigator's opinion)
N/A
Randomization description
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 Razi University of Kermanshah
Street address
Faculty of Physical Education and Sports Sciences, Kermanshah, No. 9, Razi University Blvd.
City
kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2021-05-12, 1400/02/22
Ethics committee reference number
IR.RAZI.REC.1400.013

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
ICD-10 code description
Type 2 diabetes

Primary outcomes

1

Description
Lipid profile
Timepoint
Before the intervention and after the end of the study
Method of measurement
Using a blood test

2

Description
Glycemic indexes
Timepoint
Before the intervention and after the end of the study
Method of measurement
Using a blood test

3

Description
Anthropometric indicators
Timepoint
Before the intervention and after the end of the study
Method of measurement
With little measuring tools

4

Description
Quality of Life
Timepoint
Before the intervention and after the end of the study
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: Aerobic exercise group (10 people), 8 weeks of aerobic exercise with 3 sessions per week online, the first week with an intensity of 60% of maximum heart rate for 20 minutes and in the eighth week to 75% of maximum heart rate for 40 minutes Will take minutes; Thus, during the first 4 weeks with 60% of maximum heart rate for 30 minutes and 3 days per week and during the second 4 weeks with 75% of maximum heart rate for 45 minutes and 3 days per week
Category
Lifestyle

2

Description
Intervention group: Turmeric supplement group (n = 10), in the present study, a dose of 2100 mg of turmeric will be selected.
Category
Lifestyle

3

Description
Intervention group: Aerobic exercise and turmeric supplementation, aerobic exercise group (10 people) and placebo, 8 weeks of aerobic exercise with 3 sessions per week online, the first week with an intensity of 60% maximum heart rate for 20 minutes and in the eighth week to 75% Maximum heart rate will reach 40 minutes; During the first 4 weeks with 60% of maximum heart rate for 30 minutes and 3 days a week and during the second 4 weeks with 75% of maximum heart rate for 45 minutes and 3 days a week and turmeric supplementation (10 people) In the present study, a dose of 2100 mg of turmeric will be selected
Category
Lifestyle

4

Description
Control group:No aerobic exercise and no turmeric supplement
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah Diabetes Center
Full name of responsible person
Mahsa Ahmadi Darmian
Street address
Faculty of Physical Education and Sports Sciences, Kermanshah, No. 9, Razi University Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6714844459
Phone
+98 83 3426 6383
Email
m.ahmady@stu.razi.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Rastegar Hoseini
Street address
No. 9, Razi University, Daneshgah Blvd., Bostan St., Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6714844459
Phone
+98 83 3426 6383
Email
R.hoseini@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Razi University of Kermanshah
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
Razi University of Kermanshah
Full name of responsible person
Rastegar Hosseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Physical Education and Sport Sciences, Kranshah City, Taq Bostan St., University Blvd., No.
City
kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3423 3267
Email
Rastegar.hoseini@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Rastegar Hosseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 9, Razi University, Faculty of Physical Education and Sports Sciences, Daneshgah Blvd., University Boulevard, Kermanshah, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3423 3267
Email
R.hoseni@razi.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
mahsa ahmadi darmian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physical Education and Sports Science
Street address
No. 9, Razi University, Faculty of Physical Education and Sports Sciences, Daneshgah Blvd., University Boulevard, Kermanshah, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
009834279265
Email
m.ahmady@stu.razi.ac.ir

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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data will be registered in SPSS and can be provided
When the data will become available and for how long
Access starts 9 months after the publication of all articles
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
All data can be used for citation.
From where data/document is obtainable
m.ahmady@stu.razi.ac.ir R.hoseini@razi.ac.ir
What processes are involved for a request to access data/document
If the description of the data needs is convincing, it will be delivered within 3 days
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