The effect of curcumin supplementation with High-intensity interval training on serum Irisin levels and lipid profile in non-active obese women: a randomized clinical trial "
Determining the effect of curcumin supplementation and intense interval training on serum aerosin levels and lipid profile of non-active obese women
Design
40 participants who met the inclusion criteria were selected. In the exercise group, intense intermittent exercises in the form of running and walking were used. The intensity of work was considered 80 to 100% of the reserve heart rate. The supplement-exercise group also performed the mentioned exercise program and consumed one 80 mg nanomicillin curcumin capsule daily. The curcumin supplement group took only one 80 mg nanomicillin curcumin capsule daily, and the placebo group took dextrose capsules before lunch.
Settings and conduct
The present study was a quasi-experimental study with a pretest and posttest design. The statistical population of the present study was obese women in Tabriz who were selected from sports clubs after being called and informed.
The study site is Tabriz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Entry requirements: lack of regular exercise in the last two years, lipid pattern disorder, not taking drugs and supplements
Exclusion criteria: Having thyroid, cardiovascular, respiratory, hypertension, diabetes, metabolic syndrome, pregnancy and lactation, as well as allergies to spices
Intervention groups
The subjects will be randomly divided into 4 groups of 10 people, including the control group, the exercise group + placebo, the exercise group + supplement and the supplement group.
Main outcome variables
serum aerosin levels and lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141004019397N2
Registration date:2021-09-10, 1400/06/19
Registration timing:retrospective
Last update:2021-09-10, 1400/06/19
Update count:0
Registration date
2021-09-10, 1400/06/19
Registrant information
Name
Bahram Jamali Qarakhanlou
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 9696
Email address
jamalib@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-16, 1400/04/25
Expected recruitment end date
2021-08-16, 1400/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin supplementation with High-intensity interval training on serum Irisin levels and lipid profile in non-active obese women: a randomized clinical trial "
Public title
The effect of curcumin supplementation with High-intensity interval training on serum Irisin levels and lipid profile in non-active obese women "
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 30 to 35 years,
obese (BMI greater or equal to 30),
lack of regular exercise during the last two years,
an impaired lipid profile,
not taking drugs and supplements
Exclusion criteria:
Having thyroid, cardiovascular, respiratory, hypertension, diabetes, metabolic syndrome,
pregnancy and lactation
as well as allergies to spices
unwillingness to cooperate
Age
From 30 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Blood sampling before and after the protocol
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the number of subjects, We assign a number from 1 to 40 to each of them, then we enter the site https://www.random.org/sequences, and by entering the smallest and largest number as well as the number of groups, the site itself automatically divides people into 4 groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht St., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165938634
Approval date
2021-07-05, 1400/04/14
Ethics committee reference number
IR.TBZMED.REC.1400.314
Health conditions studied
1
Description of health condition studied
obesity women
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
The rate of change in plasma aerosin
Timepoint
At baseline and two days after the last training session
Method of measurement
Sunlong Biotech kits will be used to measure aerosin
2
Description
Lipid profile changes
Timepoint
At baseline and two days after the last training session
Method of measurement
To measure lipid profile, it will be measured from Pars-Azmoon kits by ELISA method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The curcumin supplement group will take one 80 mg nanomicillin curcumin capsule daily for eight weeks before lunch with a glass of water.
Category
Other
2
Description
Intervention group: Exercise and curcumin supplementation group for eight weeks of intense interval training in the form of running and walking at 80 to 100% heart rate reserve and will take one 80 mg nanomicillin curcumin capsule daily before lunch with a glass of water.
Category
Other
3
Description
Intervention group: Exercise and placebo group in addition to daily exercise training protocol dextrose 80 mg capsules before lunch and a glass of water will be consumed.
Category
Placebo
4
Description
Control group: Dextrose 80 mg capsules once daily before lunch and a glass of water will be consumed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Call in educational and medical centers and clinics of Tabriz
Full name of responsible person
Solmaz Babaei Bonab
Street address
Third floor, No. 23, Eighth Alley, University neighborhood, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165938634
Phone
+98 41 3772 4276
Email
s.babaei@maragheh.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Faculty of Nutrition Sciences, Tabriz University of Medical Sciences,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165938634
Phone
+98 41 3336 3430
Email
ostadrahimi@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
50
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
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Jamali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Dept. of Basic Sciences, Paramedical School, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165938634
Phone
+98 41 3336 1900
Email
jamalib@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Jamali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Dept. of Basic Sciences, Paramedical School, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165938634
Phone
+98 41 3336 1900
Email
jamalib@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Jamali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Dept. of Basic Sciences, Paramedical School, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165938634
Phone
+98 41 3336 1900
Email
jamalib@tbzmed.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
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
The results of the research will be shared after publication
When the data will become available and for how long
After printing the results
To whom data/document is available
Academic and scientific researchers
Under which criteria data/document could be used
research centers
From where data/document is obtainable
Via email and contact number
What processes are involved for a request to access data/document