Protocol summary

Study aim
Effect of High Intensity Intermittent Training With and Without Turmeric Supplementation on Irisin, Thermogenin (UCP1) and visceral Fat in Obese Females
Design
Clinical trial with pre test- post test pattern, The goal of prevention, parallel groups, double blind, Sample size of 30 people in two groups (15 people in each group)
Settings and conduct
Coordination meetings, Initial measurements, Advice, Distribution of capsules and Exercises will be held at the persian Gulf club in Ayatollah Yektaei street. Blood sampling will be taken in Khalkhal Social Security Laboratory. Researcher and participants blinding for plasebo and turmeric capsuls will be done by third person.
Participants/Inclusion and exclusion criteria
Inclusion criteria: females aged 20 to 25 years old, obesity ( Body Mass Index equal and greater than 30), Not having regular exercise training, not using drug and supplement. Exclusion criteria: Having disease ,Allergy to spices, Unwillingness to cooperate with the researcher
Intervention groups
Exercise group: 3 weeks preparation training (50 to 80 percent Heart Rate Reserve(HRR)) and 6 weeks High Intensity Intermittent Training (HIIT) (80 to 100 percent HRR). 4 session per week. Exercise and Supplement group: The above-mentioned protocol In addition Turmeric supplementation ( 3 milligram Curcumin per kilogram body weight per day)
Main outcome variables
Plasma Irisin, Thermogenin (UCP1) and visceral Fat Diameter

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180317039120N1
Registration date: 2018-04-25, 1397/02/05
Registration timing: registered_while_recruiting

Last update: 2018-04-25, 1397/02/05
Update count: 0
Registration date
2018-04-25, 1397/02/05
Registrant information
Name
Zahra Rostami Hashjin
Name of organization / entity
Tabriz University
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0081
Email address
zahra.rostami.h@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-05-10, 1397/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Six Weeks High Intensity Intermittent Training With and Without Turmeric Supplementation on Irisin, Thermogenin (UCP1) and visceral Fat in Obese Females
Public title
Effect of high intensity Training and Turmeric on Obesity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a BMI equal and greater than 30 Not having Special disease history and drug consumption ( be healthy) Age range 20 to 25 years old
Exclusion criteria:
performing regular exercise training during last 6 month Allergy to spices Unwillingness to cooperate with the researcher
Age
From 20 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Using random numbers table, individuals will grouped into two groups
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 Tabriz University of Medical Sciences
Street address
Research Vice-Chancellor, Third ّfloor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.TBZMED.REC.1396.1297

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Plasma Irisin Levels
Timepoint
Before Intervention and 48 hours after last intervention session
Method of measurement
ELISA Method

2

Description
Plasma UnCoupling protein 1 (UCP1) Levels
Timepoint
Before Intervention and 48 hours after last intervention session
Method of measurement
ELISA Method

3

Description
Visceral Fat Diameter
Timepoint
Before and After Training Intervention
Method of measurement
Ultrasound Method

Secondary outcomes

1

Description
Body composition indicators
Timepoint
Before and After Intervention
Method of measurement
Body mass index, Waist–hip ratio, Body Fat - Jackson/Pollock 3-Site Caliper Method tool

2

Description
Basal Metabolism Rate
Timepoint
Before and after Intervention
Method of measurement
Mifflin and St. Jeor Equation

3

Description
Insulin Resistance
Timepoint
Before and 48 hours after intervention
Method of measurement
HOMA-IR Formula

4

Description
maximal oxygen consumption ( maximal aerobic capacity)
Timepoint
Before and after intervention
Method of measurement
Rockport test

5

Description
Plasma levels of Triglyceride, Cholesterol, LDL, HDL
Timepoint
Pre and post test
Method of measurement
Enzymatic method with AutoAnalyzer

6

Description
Liver Enzymes: Alanine Aminotransferase(ALT), Aspartate Aminotransferase (AST), Alkaline phosphatase(ALP)
Timepoint
Pre and post test
Method of measurement
Spectrophotometry

Intervention groups

1

Description
First Intervention group: Three weeks Preparation Period and Six weeks high intensity intermittent training (HIIT)
Category
Lifestyle

2

Description
Second Intervention group: First Intervention Training Protocol and turmeric Supplementation . 3 miligram curcumin per kilogram body weight per day
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center
Full name of responsible person
Mehdi Bahri Nesaz
Street address
Khalkhal Health Center, Mozzafar Azizi Ave
City
Khalkhal
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Phone
+98 45 3242 6801
Fax
+98 45 3242 2305
Email
Thelordofthebirds@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology of Tabriz University
Full name of responsible person
Abolghasem Jouyban
Street address
Tabriz University, 29 Bahman Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3110
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology of Tabriz 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
University of Tabriz
Full name of responsible person
Zahra Rostami
Position
Student
Latest degree
Master
Other areas of specialty/work
Biochemistry and exercise metabolism
Street address
Mostafa khomeini Blvd
City
Khalkhal
Province
Ardabil
Postal code
5681711111
Phone
+98 45 3245 2540
Email
zahra.rostami.h@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Ramin Amirsasan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology and Nutrition
Street address
Tabriz University, 29 Bahman Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3339 3255
Email
amirsasan@tabrizu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Zahra Rostami
Position
Student
Latest degree
Master
Other areas of specialty/work
Biochemistry and Exercise Metabolism
Street address
Mostafa Khomeini Blvd
City
Khalkhal
Province
Ardabil
Postal code
5681711111
Phone
+98 453245254
Email
zahra.rostami.h@gmail.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
There is a possibility of abuse
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
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
Title and more details about the data/document
Data file with encoding will be exposed
When the data will become available and for how long
6 Month after publication of results
To whom data/document is available
Everyone
Under which criteria data/document could be used
Use is not allowed
From where data/document is obtainable
Zahra Rostami
What processes are involved for a request to access data/document
Send request via email and receive
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