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Evaluation the interactive effect of 8- week combined aerobic-yoga training and quinoa supplementation on serum Irisin levels, lipid profile and body mass index of overweight adult women

Protocol summary

Study aim
Evaluation the interactive effect of eight-week combined aerobic-yoga training and quinoa supplementation on serum Irisin levels, lipid profile and body mass index of overweight adult women in Ardabil
Design
The study design is quasi-experimental and pre-test and post-test with the control group. The study groups will randomly divided into three experimental groups (supplement group, training group and training plus supplement group) and one control group will randomly divided.
Settings and conduct
At ardabil, group supplementation: Quinoa supplement group will consume cooked 25-gram quinoa for 8 weeks and 3 days a week. (Quinoa seed is an organic products of Aman Quinoa in Hamedan). Exercise group will perform 8-week combined aerobic-Yoga training, three session per week, include twenty-minute yoga training and twenty-five minute aerobic exercise, fifteen- minute Recovery and yoga. Exercise plus supplementation group, Exercise plus Supplement group will perform exercise program and use quinoa consumption simultaneously, like exercise group and supplement group.
Participants/Inclusion and exclusion criteria
Inactive and overweight 30-39 years women absence of orthopedic, anatomical and physiological diseases
Intervention groups
Intervention group 1: Quinoa supplement group will consume cooked 25-gram quinoa for 8 weeks and 3 days a week. (Quinoa seed is an organic products of Aman Quinoa in Hamedan). Intervention group 2 will perform 8-week combined aerobic-Yoga training, three session per week, include twenty-minute yoga training and twenty-five minute aerobic exercise, fifteen- minute Recovery and yoga. Intervention group 3: Exercise plus Supplement group will perform exercise program and use quinoa consumption simultaneously, like exercise group and supplement group.
Main outcome variables
serum Irisin levels, lipid profile and body mass index,

General information

Reason for update
Acronym
AYQSILBW
IRCT registration information
IRCT registration number: IRCT20200831048570N1
Registration date: 2020-12-07, 1399/09/17
Registration timing: retrospective

Last update: 2020-12-07, 1399/09/17
Update count: 0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Nayyer Ghayyem alaei
Name of organization / entity
The University of Mohaghegh ardebili
Country
Iran (Islamic Republic of)
Phone
+98 45 3326 0529
Email address
n.ghayemalaei@student.uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the interactive effect of 8- week combined aerobic-yoga training and quinoa supplementation on serum Irisin levels, lipid profile and body mass index of overweight adult women
Public title
Effect of aerobic-yoga training and quinoa supplementation on serum Irisin, lipid profile and body mass index overweight adult women
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age range: 30-39 old years Overweight women Inactivity
Exclusion criteria:
Absence of Anatomical, Orthopedic and Physiological disease No addiction
Age
From 30 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
N/A
Randomization description
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 Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences., University Street,
City
Ardabil
Province
Ardabil
Postal code
5618953141
Approval date
2020-01-26, 1398/11/06
Ethics committee reference number
IR.ARUMS.REC.1398.606

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum levels of irisin
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Blood sampling in the amount of 5 cc and using the human ELISA kit of the German Zelbio company

2

Description
High density lipoprotein
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Blood sampling in the amount of 5 cc and using the kit of Pars Azmoon company

3

Description
Low density lipoprotein
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Blood sampling in the amount of 5 cc and using the kit of Pars Azmoon company

4

Description
Very low density lipoprotein
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Using the formula triglyceride / 5

5

Description
Triglyceride
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Blood sampling in the amount of 5 cc and using the kit of Pars Azmoon company

6

Description
Total cholesterol
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Blood sampling in the amount of 5 cc and using the kit of Pars Azmoon company

7

Description
Body mass indexe
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Weight (KG) / Square height (m).Weight measurement with German Beurer digital scale.Height measurement by calibrated wall with Chinese bar meter

8

Description
Waist to hip ratio
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Waist measurement: In the narrowest part of the trunk, ie between the last rib and the crown of the iliac crest, a Chinese tape measure is completely attached to the skin and the size will be recorded without the skin being compressed.Measurement of hip circumference: Place a tape measure in the most voluminous part of the hip circumference, ie under the bulge of the pelvis, and the relevant number will be recorded without squeezing the skin.

9

Description
Percentage of body fat
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Using the three-point model (abdominal, scapular, triceps), Jackson and Pollack will perform a dynamic model caliper.First, the density will be obtained by the following formula: 2 (sum of three regions) 2 (0.00000084) + (sum of three regions) 000815 / 0-0982 / = body density.The percentage of fat will be obtained from the following formula: 450 - body density / 495 = body fat percentage

10

Description
Lean body mass
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Body fat weight - total body weight = lean body mass

11

Description
Body fat mass
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
body fat mass= (total weight×percentage of body fat ) / 100

Secondary outcomes

1

Description
Serum levels of irisin
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Blood sampling in the amount of 5 cc and using the human ELISA kit of the German Zelbio company

2

Description
Body mass indexe
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Weight (KG) / Square height (m).Weight measurement with German Beurer digital scale.Height measurement by calibrated wall with Chinese bar meter

3

Description
Waist to hip ratio
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Waist measurement: In the narrowest part of the trunk, ie between the last rib and the crown of the iliac crest, a Chinese tape measure is completely attached to the skin and the size will be recorded without the skin being compressed.Measurement of hip circumference: Place a tape measure in the most voluminous part of the hip circumference, ie under the bulge of the pelvis, and the relevant number will be recorded without squeezing the skin.

4

Description
Percentage of body fat
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Using the three-point model (abdominal, scapular, triceps), Jackson and Pollack will perform a dynamic model caliper.First, the density will be obtained by the following formula: 2 (sum of three regions) 2 (0.00000084) + (sum of three regions) 000815 / 0-0982 / = body density.The percentage of fat will be obtained from the following formula: 450 - body density / 495 = body fat percentage

5

Description
Lean body mass
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Body fat weight - total body weight = lean body mass

6

Description
Body fat mass
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
body fat mass= (total weight×percentage of body fat ) / 100

7

Description
High-density lipoprotein
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Blood sampling in the amount of 5 cc and using the kit of Pars Azmoun Company kit

8

Description
Low density lipoprotein
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Blood sampling in the amount of 5 cc and using the kit of Pars Azmoun Company kit

9

Description
Very low density lipoprotein
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Using the formula triglyceride / 5

10

Description
Tri glyceride
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Blood sampling in the amount of 5 cc and using the kit of Pars Azmoun Company kit

11

Description
Total cholesterol
Timepoint
24 hours before the start of the study and 48 hours after the end
Method of measurement
Blood sampling in the amount of 5 cc and using the kit of Pars Azmoun Company kit

Intervention groups

1

Description
Intervention group 1: Quinoa supplement group will consume cooked 25-gram quinoa for 8 weeks and 3 days a week. (Quinoa seed is an organic products of Aman Quinoa in Hamedan).
Category
Prevention

2

Description
Intervention group 2: 8-week combined aerobic-Yoga training, three session per week, include twenty-minute yoga training and twenty-five minute aerobic exercise, fifteen- minute Recovery and yoga
Category
Prevention

3

Description
Intervention group 3: Exercise plus Supplement group will perform exercise program and use quinoa consumption simultaneously, like exercise group and supplement group.
Category
Prevention

4

Description
Control group: No intervention was made.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ardabil city level
Full name of responsible person
Nayyer Ghayyem alaei
Street address
Quds Street
City
Ardebil
Province
Ardabil
Postal code
5613958917
Phone
+98 45 3326 0529
Email
n.ghayemalayi@student.uma.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Ghorbani
Street address
Mohaghegh Ardabili University.,University Street,
City
Ardabil
Province
Ardabil
Postal code
5619913131
Phone
+98 45 3351 0136
Email
ghorbani@uma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mohaghegh Ardabili 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
The Mohaghegh Ardabili University
Full name of responsible person
Nayyer Ghayyem Alaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Mohaghegh Ardabili University.,University Street
City
Ardabil
Province
Ardabil
Postal code
5619913131
Phone
+98 45 3326 0529
Email
n.ghayemalaei@student.uma.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The university of Mohaghegh
Full name of responsible person
Nayyer ghayyem Alaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Mohaghegh Ardabili University.,University Street
City
Ardabil
Province
Ardabil
Postal code
5619913131
Phone
+98 45 3326 0529
Email
n.ghayemalaei@student.uma.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Mohaghegh ardebili
Full name of responsible person
Nayyer Ghayyem alaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Mohaghegh Ardebili University., Daneshgah Ave
City
Ardebil
Province
Ardabil
Postal code
5619913131
Phone
+98 45 3326 0529
Fax
Email
n.ghayemalaei@student.uma.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
Yes - There is 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
After statistical analysis, the general information of the subjects will be shared in the form of final results and in the article, while preserving the privacy of the subjects and without identifying them.
When the data will become available and for how long
Access started from 1400
To whom data/document is available
Everyone
Under which criteria data/document could be used
Everyone
From where data/document is obtainable
n.ghayemalaei@student.uma.ac.ir
What processes are involved for a request to access data/document
Irandac tracking code
Comments
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