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The Effect Of 8 Weeks Combined Training (Aerobic-Resistance) At Home With Quinoa Seed Supplementation On Total Antioxidant Capacity And Appetite In Women With Type 2 Diabetes

Protocol summary

Study aim
Determining the effect of 8 weeks of combined training (aerobic-resistance) at home with quinoa seed supplementation on total antioxidant capacity and appetite in women with type 2 diabetes
Design
Exercise plus supplement group and supplement group consume 25 grams/day of cooked quinoa seeds in the morning for 8 weeks. Exercise plus supplement group perform combined exercise 3 days in week for 8 weeks. Combined exercise: 5-10 minutes warm-up, then main exercise that includes 30 minutes of resistance training and after that; 30 minutes of aerobic training that includes walking. The control group also engages in their normal daily activities for 8 weeks.
Settings and conduct
Exercise plus supplement group and supplement group consume 25 grams/day of cooked quinoa seeds in the morning for 8 weeks. Exercise plus supplement group perform combined exercise 3 days in week for 8 weeks. Combined exercise: 5-10 minutes warm-up, then main exercise that includes 30 minutes of resistance training and after that; 30 minutes of aerobic training that includes walking. The control group also engages in their normal daily activities for 8 weeks.
Participants/Inclusion and exclusion criteria
Less than ten years Suffering type 2 diabetes, A1c level between 6.4 to 10, Don't use insulin, No regular exercise, No pregnancy, No quinoa seed allergy, 35-65 years old
Intervention groups
Exercise plus supplement group and supplement group consume 25 grams/day of cooked quinoa seeds in the morning for 8 weeks. Exercise plus supplement group perform combined exercise 3 days in week for 8 weeks. Combined exercise: 5-10 minutes warm-up, then main exercise that includes 30 minutes of resistance training and after that; 30 minutes of aerobic training that includes walking. The control group also engages in their normal daily activities for 8 weeks.
Main outcome variables
Total antioxidant capacity; Appetite

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200804048306N1
Registration date: 2021-04-13, 1400/01/24
Registration timing: retrospective

Last update: 2021-04-13, 1400/01/24
Update count: 0
Registration date
2021-04-13, 1400/01/24
Registrant information
Name
nillofar moradi
Name of organization / entity
The razi university of kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3429 5590
Email address
n.moradi@stu.razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-14, 1399/12/24
Expected recruitment end date
2021-03-17, 1399/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of 8 Weeks Combined Training (Aerobic-Resistance) At Home With Quinoa Seed Supplementation On Total Antioxidant Capacity And Appetite In Women With Type 2 Diabetes
Public title
The Effect Of 8 Weeks Combined Training (Aerobic-Resistance) At Home With Quinoa Seed Supplementation On Total Antioxidant Capacity And Appetite In Women With Type 2 Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The present study will be conducted by quasi-experimental research method and pre-test-post-test design, one-sided blind and random selection. In this randomized one-blind design with a 15% probability 36 women with type 2 diabetes (35-65 years) in Kermanshah will be selected as a statistical sample. After obtaining permission from the ethics committee of Razi University of Kermanshah and after being called to the Diabetes Center, participants who have been suffering from diabetes for less than ten years will be called. Inclusion criteria include: less than ten years of type 2 diabetes at the discretion of the treating physician, A1c level between 6.4 to 10, no insulin use, no regular exercise, no pregnancy, no allergy to quinoa seeds, age 35-64 years. All subjects are explained the goals and nature of the research and individuals participate in the research voluntarily. Subjects are assured that the information will remain confidential and that the information will be used solely for the purposes of this study. Subjects can leave the study any time that they want.
Exclusion criteria:
Exclusion criteria include: use of insulin during the study, hospitalization during the study, intolerance to exercise (expression of discomfort, severe lethargy, imbalance and confusion), cardiovascular disease, lack of regular participation Exercises, foot ulcers and complications in the legs during the study.
Age
From 35 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
This research is of quasi-experimental type with pre-test and post-test design. The statistical population of this study is women in the age range of 35 to 65 years and with type 2 diabetes in Kermanshah, who will be selected by clinical trials. According to the corona conditions, the sample size will be estimated at 36 people: then the subjects will be divided into 3 groups using simple random sampling, including: the first group: quinoa supplement (12 people); The second group: quinoa supplementation and resistance-aerobic exercise (12 people); Third group: control (12 people) will be divided. None of the subjects will be aware of the status of supplementation and groupings. The researcher numbers the names of the subjects and puts the numbers in an envelope and another person enters the names and puts them in 3 groups, respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
This research is of quasi-experimental type with pre-test and post-test design. The statistical population of this study is women in the age range of 35 to 65 years and with type 2 diabetes in Kermanshah, who will be selected by clinical trials. According to the corona conditions, the sample size will be estimated at 36 people: then the subjects will be divided into 3 groups using simple random sampling, including: the first group: quinoa supplement (12 people); The second group: quinoa supplementation and resistance-aerobic exercise (12 people); Third group: control (12 people) will be divided. None of the subjects will be aware of the status of supplementation and groupings. The researcher numbers the names of the subjects and puts the numbers in an envelope and another person enters the names and puts them in 3 groups, respectively.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Ethics Committee in Biomedical Research
Street address
Karmandan Street, Station 4
City
kermanshah
Province
Kermanshah
Postal code
6715769751
Approval date
2021-03-13, 1399/12/23
Ethics committee reference number
1399.006IR.RAZI.REC

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E10, E11
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Antioxidants are compounds that are able to protect biological systems against the harmful effects of reactive oxygen species and oxygen. In fact, antioxidants play an important role in inhibiting the active species of oxygen and nitrogen and preventing their formation. The involvement of reactive oxygen species, oxygen, nitrogen and chlorine in the pathology of many diseases, including type 2 diabetes, has been well established. Therefore, the effect of quinoa seeds and exercise on total antioxidant capacity and appetite in people with type 2 diabetes is investigated.
Timepoint
2 months
Method of measurement
By blood measurements

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The exercise plus supplement group and the supplement group will consume 25 grams/day of cooked quinoa seeds with a snack in the morning and from 10 to 11 o'clock for 8 weeks.
Category
Other

2

Description
Intervention group: Exercise plus supplement group also performs combined training (aerobic-resistance) 3 days in week for 8 weeks. The combined training program includes: 5-10 minutes warm-up (stretching and kinetic movements), the main body of the combined training includes 30 minutes of resistance training and then 30 minutes of aerobic training, which includes walking at a preferred speed. Resistance exercises will be done 8 to 12 repetitions in 3 sets (the first week 8 repetitions for body adaptation, the second and third weeks 10 repetitions and finally the fourth to eighth weeks 12 repetitions) with 60 second rest intervals between each set.
Category
Other

3

Description
Control group: The control group also engages in their normal daily activities for 8 weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Diabetes Center of Kermanshah
Full name of responsible person
Nillofar moradi
Street address
karmandan Street, Station 4
City
kermanshah
Province
Kermanshah
Postal code
6715769751
Phone
+98 83 3429 5590
Email
n.moradi@stu.razi.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Elham Niromand
Street address
Karmandan Street, Station 4
City
kermanshah
Province
Kermanshah
Postal code
6715769751
Phone
+98 83 3429 5590
Email
n.moradi@stu.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
Proportion provided by this source
100
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Nillofar moradi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Karmandan Street, Station 4
City
kermanshah
Province
Kermanshah
Postal code
6715769751
Phone
+98 83 3429 5590
Email
n.moradi@stu.razi.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Nillofar moradi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Karmandan Street, Station 4
City
Kermanshah
Province
Kermanshah
Postal code
6715769751
Phone
+98 83 3429 5590
Email
n.moradi@stu.razi.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Nillofar moradi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Karmandan Street, Station 4
City
Kermanshah
Province
Kermanshah
Postal code
6715769751
Phone
+98 83 3429 5590
Email
n.moradi@stu.razi.ac.ir

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
There is no more information
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
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