Effect of four weeks flaxseed supplementation and concurrent training on certain factors of cardiovascular disease and cortisol hormones in overweight women
The effect of four weeks concurrent training with flax seed supplementation on lipid profile (cholesterol and LDL, TG, HDL) and cortisol changes in overweight women.
Design
In this study, 36 healthy women overweight and eligible for entry into the study who are referred to university sports centers are selected.Participants were randomly divided into four homogeneous groups (supplementation: 9 people, exercise + supplementation: 9, exercise: 9, 9 controls), of which three groups were an intervention group and a control group, and each One participant is assigned a code.
Settings and conduct
The research on the treatment of overweight and it will be done randomly in University of Tabriz.The present study was carried out in a semi-experimental study.
Participants/Inclusion and exclusion criteria
Entry criteria: Female students of Tabriz University; Inactivity; Overweight; BMI between 25 and 29/9. Non-compliance criteria: Smoking; Cardiovascular disease and surgery; Having chronic illnesses; taking any type of fat supplement; having regular exercise.
Intervention groups
Intervention 1: Includes 9 supplementary with training
Intervention 2: Includes 9 concurrent training
Intervention 3: Includes 9 supplementation Flaxseed
Controls: Includes 9 people without any intervention
Main outcome variables
It is expected that four weeks of concurrent training, along with flaxseed supplementation, can have a positive effect on the lipid profiles (cholesterol, HDL-LDL-TG) and cortisol hormonal index.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171130037689N1
Registration date:2018-03-03, 1396/12/12
Registration timing:retrospective
Last update:2018-03-03, 1396/12/12
Update count:0
Registration date
2018-03-03, 1396/12/12
Registrant information
Name
Fateme Halalkhor
Name of organization / entity
The University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 4224 1099
Email address
m_nikkhesal@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-20, 1396/09/29
Expected recruitment end date
2018-01-19, 1396/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of four weeks flaxseed supplementation and concurrent training on certain factors of cardiovascular disease and cortisol hormones in overweight women
Public title
Effect of flaxseed supplementation and concurrent training on overweight
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
women Students University of Tabriz
Inactivity
overweight
BMI Between 25 and 29/9
Exclusion criteria:
Smoking
Cardiovascular disease and surgery
Chronic Diseases
Consumption any kind of supplement fat burner
Regularly have exercise activities
Age
From 20 years old to 29 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the university will be called upon to invite all women who are overweight to participate in the current study, and then from among the volunteers willing to participate in the study, 36 eligible people will study The age range of 20 to 29 years will be selected. In order to homogenize the subjects, age, height, weight, fat percentage and some blood parameters of all subjects will be measured. Finally, considering these indices and using the Shapiro - Wilk test and ensuring the homogeneity of the data, 36 people will be randomly assigned to four homogeneous groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sport Sciences Research Institute of Iran
It will be measured using the radioimmunoassay method.
5
Description
Malondialdehyde (MDA)
Timepoint
Before and after the exercise period
Method of measurement
Colorimetric method using Germany kit (BioCore)
6
Description
Total antioxidant capacity of the blood
Timepoint
Before and after the exercise period
Method of measurement
Spectrophotometry and ELISA
Intervention groups
1
Description
Intervention group1: flaxseed supplement (62.0 g / kg of body weight per day) in flaxseed supplementary group. Your flaxseed used in this study is from the Green Healing Faculty in Tabriz And was then ground and delivered as powder or broken and participated in a digital scale (0.62 grams per kilogram of body weight per day) in a pack containing three parts. Samples were asked to dissolve each package an hour before food, in three meals, and within 250 milligrams of water.
Category
Lifestyle
2
Description
Intervention group 2: concurrent training (endurance-resistance) in the training group. concurrent training included aerobic exercises with an intensity of 65% of heart rate and resistance training with intensity of 60% 1RM
Category
Lifestyle
3
Description
Intervention group 3: concurrent training (endurance-resistance) and supplementation of flaxseed (62.0 g / kg of body weight per day) in the training group + flaxseed supplement
Category
Lifestyle
4
Description
Control group: They did not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Tabriz
Full name of responsible person
Fateme HalalKhor
Street address
29 Bahman Blvd.,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 4224 1099
Email
m_nikkhesal@tabrizu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Tabriz - Research Deputy
Full name of responsible person
Dr. Eskandar Fathi Azar
Street address
29 Bahman Blvd.,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3339 3635
Fax
+98 41 3334 4272
Email
e-fathiazar@tabrizu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tabriz - Research Deputy
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
Fateme HalalKhor
Position
دانشجو
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
29 Bahman Blvd.,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 4224 1099
Fax
Email
m_nikkhesal@tabrizu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Vahid Sari-Sarraf
Position
Associate Professor in Sport Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
29 Bahman Blvd.,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5414646871
Phone
+98 41 3339 3251
Fax
Email
sarraf@tabrizu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Fateme Halalkhor
Position
Student
Latest degree
Master
Other areas of specialty/work
Traditional Medicine
Street address
29 Bahman Blvd.,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5414646871
Phone
+98 41 4224 1099
Fax
Email
m_nikkhesal@tabrizu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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