Explaining the Effect of 12 weeks of Endurance training with Cur cumin Supplementation on Lipocalin_2 levels and lipid profile in Inactive Women.
Design
First in several public places, parks, streets, offices and. The city of Tehran was informed and through the distribution of leaflets and tracts, eligible people were called 44 people were randomly selected to participate in the Researcher Intervention.
Settings and conduct
Subjects were present in the pre-test stage to measure the variables and blood samples were taken in the pre-test stage. Also, their height and weight will be measured with scales and gauges
Placebo Take the placebo and continue the normal daily life of 11 people
Cur cumin supplementation Cur cumin Supplementation and Non-Aerobic Exercise 11 people
Aerobic Exercise taking placebo and 12 weeks Aerobic exercise 11 people.
Participants/Inclusion and exclusion criteria
Overweight Women between the ages of 27 and 40
Lack of diseases such as type 2 diabetes, Hypertension and so on
At least in recent years, Subjects have not participated in a regular Exercise Program.
Intervention groups
Cur cumin Supplementation on Lipocalin_2 levels and Lipid profile in Inactive Women in four equal groups including Placebo and Cur cumin Supplementation and aerobic Exercise and training
Aerobic + Cur cumin Supplements were divided.
Main outcome variables
Community Health.
Prevention of Cardiovascular disease.
Type 2 diabetes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220305054187N1
Registration date:2022-05-12, 1401/02/22
Registration timing:registered_while_recruiting
Last update:2022-05-12, 1401/02/22
Update count:0
Registration date
2022-05-12, 1401/02/22
Registrant information
Name
Saeed Rezaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2308 2902
Email address
saeedrezaeesport@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-20, 1401/01/31
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Endurance Training along with cur Cumin Supplementation on the levels of Lipocalin-2 and Lipid profile in Sedentary Women.
Public title
Investigation of CurCumin on Lipocalin-2 levels and Lipid profile in Inactive Women.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria are Non-Participation of Subjects in regular Exercise during the past year. No infection to Type 2 diabetes No infection to other chronic diseases such as cancer, Have not history of heart disease. No physical limitations and Medical To Participate in Sports Exercises.
Exclusion criteria:
Age
From 27 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
For Randomization, we divide the Subjects into four groups: Placebo group from number 1 to 11 cur cumin Supplement group from number 12 to 22 Aerobic exercise group from number 23 to 33 and Aerobic Exercise Group and cur cumin Supplement from Number 34 to 44 that each person must select a number from the container that has been prepared for this case and Numbers 1 to 44 are already in it.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements and Placebo are in the hands of a third party.The Researcher and the Subject did not know about the pills taken so that the Researcher
did not have a bias towards the Exercise Group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Headquarters of the Ministry of Health.
Street address
North Seol, vanak, tehran, Ministry of Sport and Youth
City
Tehran
Province
Tehran
Postal code
1995613711
Approval date
2022-02-26, 1400/12/07
Ethics committee reference number
IR.IAU.SRB.REC.1400.297
Health conditions studied
1
Description of health condition studied
The Effect of Endurance training with Cur cumin Supplementation on Lipocalin_2 levels and lipid profile In inactive women.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The blood samples are immediately poured into a Falcon tube and then centrifuged at 3,000 rpm for 15 minutes to separate the serum. Serum samples were also stored in the freezer until blood variables were measured. Measurements of lipocalin_2 and cholesterol, triglyceride levels are performed using Pars Company kit.
Timepoint
Blood sampling training week at the beginning and end of 12 weeks.
Method of measurement
Blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Curcumin Supplement Group.
Category
Lifestyle
2
Description
Aerobic Exercise Group.
Category
Lifestyle
3
Description
Intervention Group: Aerobic Exercise and cur Cumin Supplement.
Category
Lifestyle
4
Description
Control Group: Pharmacologica Group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Parks and Streets of Tehran.
Full name of responsible person
SAEED REZAEE
Street address
North Seol, Vanak, Tehran, Ministry of Sport and Youth
City
TEHRAN
Province
Tehran
Postal code
1995613711
Phone
+98 21 2308 2902
Fax
+98 21 2308 2907
Email
saeedrezaeesport@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
SAEED REZAEE
Street address
Hesarak Martyrs Boulevard, University Square,
City
TEHRAN
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
saeedrezaeesport@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
SAEED REZAEE
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
Islamic Azad University
Full name of responsible person
Saeed Rezaee
Position
Employee of Ministry of Sport an Youth
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
North Seol, Vanak, Tehran, Minietry of Sport and Youth.
City
TEHRAN
Province
Tehran
Postal code
1995613711
Phone
+98 21 2308 2902
Email
saeedrezaeesport@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
SAEED REZAEE
Position
Employee of Ministry of Sport and Youth
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
North Seol, Vanak, Tehran,
City
TEHRAN
Province
Tehran
Postal code
1995613711
Phone
009826082902
Email
saeedrezaeesport@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
SAEED REZAEE
Position
Employee of Ministry Sport and Youth
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
North Seol, Vanak, Tehran.
City
TEHRAN
Province
Tehran
Postal code
19995613711
Phone
+98 21 2308 2902
Email
saeedrezaeesport@gmail.com
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Explain the Effect of 12 weeks of endurance training with Curcumin Supplementation on lipocalin_2 levels and lipid profile
Inactive in women. Information about the main outcome can be shared.
When the data will become available and for how long
6 Month later after publishing result
To whom data/document is available
Every one
Under which criteria data/document could be used
For study
From where data/document is obtainable
SAEED REZAEE
What processes are involved for a request to access data/document