The Effects of L-Carnitine Supplementation during Endurance Training on Some Serum Angiogenesis Indices and Blood Pressure Changes in Obese Young Women
The purpose of this research is to investigate the effects of l-carnitine supplementation during endurance training on some serum angiogenesis indices and blood pressure changes in obese young women.
Design
A clinical trial with a control group, parallel, double-blind, randomized, with a predicted sample size of 40 and phase 3 trial
Settings and conduct
This study will be conducted on obese women living in the city of Marivan. The duration of the research is 8 weeks and the participants are divided into four groups randomly. The interventional factor including endurance and l- carnitine supplementation is considered for this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being 20–30 years old, being female, having a body mass index over than 30 kg/m2;
exclusion criteria: smoking, taken the drug or supplement, having a kind of specific disease and having regular exercise.
Intervention groups
Intervention group 1: Implementation of endurance exercise with consuming 3 grams of l- carnitine supplementation for 8 weeks
Intervention group 2: Implementation of endurance exercise with consuming 3 grams of placebo (maltodextrin) for 8 weeks
Intervention group 3: Consumption of 3 grams of l- carnitine supplementation alone for 8 weeks
Intervention group 4: Control group (they will not receive any intervention)
The Effects of L-Carnitine Supplementation during Endurance Training on Some Serum Angiogenesis Indices and Blood Pressure Changes in Obese Young Women
Public title
The effect of exercise training with ingested of l-carnitine on angiogenesis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Participants in the current study must be non-athlete
Participants in the current study must be at the age range of 20-30 years
Participants in the current study must be woman
Participants in the current study must be obese
Exclusion criteria:
People who consuming tobacco are not allowed to participate in this study
People who taking the drug or nutrition supplement are not allowed to participate in this study
People who having a kind of special disease are not allowed to participate in this study
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random, the chance of all subjects for divided into two groups of supplement and placebo were similar
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and researchers in this study will be blind to the use of supplementation or placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran Street
City
Sananndaj
Province
Kurdistan
Postal code
6617713446
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.MUK.REC.1398.079
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Endothelial growth factor
Timepoint
Basal state and after 8 week
Method of measurement
Based on nanogram per liter with ELISA method
2
Description
Nitric oxaide
Timepoint
Basal state and after 8 week
Method of measurement
Based on micromole per liter with ELISA method
3
Description
Interleukin 6
Timepoint
Basal state and after 8 week
Method of measurement
Based on picogram per milliliter with ELISA method
4
Description
Endostatin
Timepoint
Basal state and after 8 week
Method of measurement
Based on nanogram per liter with ELISA method
5
Description
Blood pressure
Timepoint
Basal state and after 8 week
Method of measurement
Based on millimeter mercury with digital blood pressure monitor
6
Description
Interleukin 4
Timepoint
Basal state and after 8 week
Method of measurement
Based on nanogram per liter with ELISA method
7
Description
Interleukin 8
Timepoint
Basal state and after 8 week
Method of measurement
Based on nanogram per liter with ELISA method
Secondary outcomes
empty
Intervention groups
1
Description
ّFirst intervention group: The subjects of endurance exercise with l- carnitine group will participate in 8 weeks of endurance training with the ingestion of l- carnitine supplement. Blood samples will take in basal state and after 8 weeks.
Category
Prevention
2
Description
second intervention group: The subjects of endurance exercise with placebo group will participate in 8 weeks of endurance training with the ingestion of placebo. Blood samples will take in basal state and after 8 weeks.
Category
Prevention
3
Description
Third intervention group: The subjects of l- carnitine group will participate in 8 weeks of ingestion of l- carnitine supplement. Blood samples will take in basal state and after 8 weeks.
Category
Prevention
4
Description
Control group: The subjects of control group (There will be no intervention). Blood samples will take in basal state and after 8 weeks.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sanandaj Branch, Islamic Azad University
Full name of responsible person
Maryam Ali-Mohammadi
Street address
Islamic Azad University, Pasdaran Blvd, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Email
Maryam.alimohamadi66@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Abdollah Refaei
Street address
Islamic Azad University, Pasdaran Blvd, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8677
Email
refaei@iausdj.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad 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
Islamic Azad University
Full name of responsible person
Maryam Ali- Mohammadi
Position
Phd Student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University, Pasdaran Blvd, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Email
Maryam.alimohamadi66@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kamal Aziz-Beigi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University, Pasdaran Blvd, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Email
kazizbeigi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Hakimi
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Islamic Azad University, Pasdaran Blvd, Sanandaj
City
ُSanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Email
Mehdihakimi@uma.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All relevant data and tests will be published without mentioning the name.
When the data will become available and for how long
Data will be available after the publication of the articles.
To whom data/document is available
All researchers can access the data.
Under which criteria data/document could be used
The possibility of using this data to analyze and write an article will not be given to individuals.
From where data/document is obtainable
By emailing the accountability officer, they can access the documentation.
What processes are involved for a request to access data/document
After receiving the email, the file will be sent to the researchers.