The effect of combined training with and without consuming the flaxseed ، on the estrogen hormone, also on the Lipid profile and insulin resistance of postmenopausal women
The purpose of this study would be studying the effect of the combined training on the estrogen hormone, the lipid profile and the insulin resistance, with and without using the flax seed, in the menopause women inactive.
Design
A clinical trial with a pre-test, post-test, community-based approach with two randomized groups
Settings and conduct
Location: City of Torbat Heydarieh
Collecting samples from people referring to health centers.
Semi-experimental research with two groups of combined exercises and combined exercise group with flaxseed
Participants/Inclusion and exclusion criteria
1.Inactive postmenopausal women
2.One year since the last menstruation
3.non-use of hormone therapy
4.having a BMI between 25 and 30
5.having a fat percentage of over 25
6.and having no regular exercise in the last 6 months
Intervention groups
Combined exercise group, Combined exercise group plus flaxseed supplement
Main outcome variables
Lipid Indices (LDL, HDL, TG, COL)
Estrogen
Insulin resistance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171031037142N2
Registration date:2018-02-12, 1396/11/23
Registration timing:retrospective
Last update:2018-02-12, 1396/11/23
Update count:0
Registration date
2018-02-12, 1396/11/23
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5229 9300
Email address
jahanshiri.nasrin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-02-29, 1394/12/10
Expected recruitment end date
2016-04-08, 1395/01/20
Actual recruitment start date
2016-03-05, 1394/12/15
Actual recruitment end date
2016-04-08, 1395/01/20
Trial completion date
empty
Scientific title
The effect of combined training with and without consuming the flaxseed ، on the estrogen hormone, also on the Lipid profile and insulin resistance of postmenopausal women
Public title
The effect of combination training and flax on menopausal complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
One year since the last menstruation,
having a body mass index of 25-30 kg / m2,
having a fat percentage of over 25%,
Exclusion criteria:
not using hormone therapy
and not having regular exercise in the last 6 months
Age
From 50 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
27
Randomization (investigator's opinion)
Randomized
Randomization description
To determine the subjects in the training group and the exercise group with supplementation, from 1 to 30, it was written on small sheets and placed inside the box. Individuals extracted a number from the inside of the box before the first training session, if the desired number was paired, the person in the training group and, if the number was the one, the person was supplemented in the training group
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
Mashhad Ferdowsi University
Street address
Azadi Square, Ferdowsi University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
IR.MUM.FUM.REC.1396.05
Health conditions studied
1
Description of health condition studied
In this study, the disease has not been studied and the subjects are healthy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Estrogen is a collection of female sex hormones that consists of three main types of 17 beta-estradiol, estradiol and sterile, and is the main cause of female secondary sex traits. In this study, estradiol levels, the most important type of estrogen, were measured by blood sampling
Timepoint
Blood samples were collected for measuring estrogen 24 hours before and 48 hours after the last exercise session.
Method of measurement
To measure estrogen, the Japanese Toseh Kit was used
2
Description
Insulin resistance is called insulin resistance, because of the inability of the body to produce enough insulin or the inability to use insulin effectively. Insulin resistance was measured using the Homa formula.
Timepoint
Blood samples were collected for measuring insulin resistance 24 hours before and 48 hours after the last exercise session.
Method of measurement
In order to measure insulin and glucose, a kit of Pars tazmon was used in Iran
3
Description
Fat Profile: Blood lipids that appear in the form of triglycerides of cholesterol and lipoprotein (HDL, LDL).
Timepoint
Blood samples were collected for measuring fat profile, 24 hours before and 48 hours after the last exercise session.
Method of measurement
To determine the fat profile, the Pars azmon kits of Iran were used
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: combined training (The aerobic exercise was preformed with the intensity of 60 to 80 percent of the maximal heart rate and the resistance exercise with 4moves bench presses, wide grip last pull down, leg extension and lying leg curls with the intensity of 60 to 80 percent of a maximal repetition)
Category
Other
2
Description
Intervention group: combined training(The aerobic exercise was preformed with the intensity of 60 to 80 percent of the maximal heart rate and the resistance exercise with 4moves bench presses, wide grip last pull down, leg extension and lying leg curls with the intensity of 60 to 80 percent of a maximal repetition)plus flaxseed (using 25 grams of the milled flaxseed )
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers
Full name of responsible person
Heydarbeygi Mina
Street address
Valiasr Township, Daneshahr Crossroads
City
Torbat Heidariyeh
Province
Razavi Khorasan
Postal code
9516143440
Phone
+98 51 5229 2584
Email
jahanshiri.nasrin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad Ferdowsi University
Full name of responsible person
Ahmad Reza Bahrami
Street address
Freedom Square, Ferdowsi University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 5000
Email
pr@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad Ferdowsi University
Proportion provided by this source
75
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
Mashhad Ferdowsi University
Full name of responsible person
Jahanshiri Nasrin
Position
Physical Education Instructor
Latest degree
Master
Other areas of specialty/work
Physical Education / Exercise Physiology
Street address
Valiasr Township, Laleh 2, No. 12
City
Torbat Heidarieh
Province
Razavi Khorasan
Postal code
9516143459
Phone
+98 51 5229 9300
Email
jahanshiri.nasrin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Ferdowsi University
Full name of responsible person
Jahanshiri Nasrin
Position
Physical Education Instructor
Latest degree
Master
Other areas of specialty/work
Physical Education / Exercise Physiology
Street address
Valiasr Township, Laleh 2, No. 12
City
Torbat Heidariyeh
Province
Razavi Khorasan
Postal code
9516143459
Phone
+98 51 5229 9300
Email
jahanshiri.nasrin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Ferdowsi University
Full name of responsible person
Jahanshiri Nasrin
Position
Physical Education Instructor
Latest degree
Master
Other areas of specialty/work
Physical Education / Exercise Physiology
Street address
Valiasr Township, Laleh 2, No. 12
City
Torbat Heidariyeh
Province
Razavi Khorasan
Postal code
9516143459
Phone
+98 51 5229 9300
Email
jahanshiri.nasrin@yahoo.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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All individual data of the participants in this study can be subscribed to after being unidentifiable
When the data will become available and for how long
Start the access period 3 months after printing the results
To whom data/document is available
Researchers working in academic institutions and health centers
Under which criteria data/document could be used
Use data and research results to help the community and conduct further research
From where data/document is obtainable
Email jahanshiri.nasrin@yahoo.com
What processes are involved for a request to access data/document
After receiving the email and ensuring that the reason for the request is one month