The effect of high-intensity interval training and beta-alanine supplementation on the basal levels and acute exercise response of oxidative-inflammatory markers in overweight/obese men
This study aimed to investigate the synergistic effects of six weeks of high-intensity interval training and beta-alanine supplementation as a limiting precursor of intramuscular carnosine synthesis on basal levels and acute exercise response of oxidative-inflammatory markers in overweight and obese men.
Design
The clinical trial includes a double-blind control group and three other groups, randomized on 28 overweight and obese men aged 18 to 35 years. Also, the tools available on the GraphPad website will be used for randomization.
Settings and conduct
The study will be conducted in the Sports Physiology Laboratory of Shahid Beheshti University. The subjects will be invited to study with an announcement. After early tests conduction, the subjects will be divided into four groups randomly and double-blindly. after that, the main intervention will be done for six-week, and the post-test will be done.
Participants/Inclusion and exclusion criteria
Include: Men; Inactive; Age 18 to 35 years; Body mass index 25 to 35 kg per square meter؛ Body fat percent 25 to 35%;
Exclude: smoking; Alcohol consumption; Blood Glucose above 110 mg/dL; Hematocrit below 35%; Hemoglobin below 13 g/dL; Leukocyte more than 11,000 per Micro liter; Having an underlying disease
Intervention groups
1- Training and beta-alanine group: Six weeks of high-intensity interval training, along with a daily intake of 6.4 grams of beta-alanine; 2- Training and placebo group: Six weeks of high-intensity interval training, along with a daily intake of 6.4 grams of dextrose (placebo); 3- beta-alanine group: daily intake of 6.4 grams of beta-alanine without any training; 4- Control group: daily intake of 6.4 grams of dextrose (placebo) without any training.
The effect of high-intensity interval training and beta-alanine supplementation on the basal levels and acute exercise response of oxidative-inflammatory markers in overweight/obese men
Public title
Effect of high-intensity interval training on obesity
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Men
Body mass index from 25 to 35 kilogram per square meter
All persons with at least 25 percent body fat
Inactive
Age 18 to 35 years
Exclusion criteria:
Smoking
Having an underlying disease
Blood Glucose above 110 mg per liter;
Hematocrit below 35%
Hemoglobin below 13 g/dl
WBC count more than 11,000 per microliter
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be divided individually into four groups by the simple randomization method and with the help of the randomization tool available on the GraphPad website (www.graphpad.com).
Blinding (investigator's opinion)
Double blinded
Blinding description
All subjects participating in the study will receive identical capsules, which will have the same appearance. Dextrose will be used as the placebo due to its identical appearance to beta-alanine. Subjects will not be informed of the type of supplement they are taking until the end of the study. All the capsules will be prepared by someone outside the study and will be given to the subjects by the same person, and the researchers will not know the type of capsule consumed by the subjects.
Also, the grouping and randomization of subjects will be done by someone outside the study. The main researcher and the data evaluator will not know about the grouping of subjects until the end of the study. The analyzer will also analyze the data without knowing which data belongs to each group. Then it will be clear which data belongs to each group.
At the beginning of the study, six weeks after the start of the supplement and exercises and 30 minutes after the end of the last training session.
Method of measurement
Using ELISA method and kit made in Germany (LDN company).
2
Description
Serum high-sensitivity C-reactive protein (hs-CRP)
Timepoint
At the beginning of the study, six weeks after the start of the supplement and exercises and 30 minutes after the end of the last training session.
Method of measurement
Using ELISA method and kit made in Germany (LDN company).
3
Description
Serum interleukin 10
Timepoint
At the beginning of the study, six weeks after the start of the supplement and exercises and 30 minutes after the end of the last training session.
Method of measurement
Using ELISA method and kit made in Germany (LDN company).
4
Description
Serum Malondialdehyde (MDA)
Timepoint
At the beginning of the study, six weeks after the start of the supplement and exercises and 30 minutes after the end of the last training session.
Method of measurement
Using Fluorometric method and kit made in Iran (KPG company).
5
Description
Serum total antioxidant capacity
Timepoint
At the beginning of the study, six weeks after the start of the supplement and exercises and 30 minutes after the end of the last training session.
Method of measurement
Using Fluorometric method and kit made in Iran (KPG company).
Secondary outcomes
1
Description
Body Composition
Timepoint
At the beginning of the study and six weeks after the start of the supplement and training.
Method of measurement
Using inbody 770 machine
2
Description
High Density Lipoprotein (HDL)
Timepoint
At the beginning of the study and six weeks after the start of the supplement and training.
Method of measurement
Using Hitachi 717 machine and kit made in Iran.
3
Description
Low Density Lipoprotein (LDL)
Timepoint
At the beginning of the study and six weeks after the start of the supplement and training.
Method of measurement
Using Hitachi 717 machine and kit made in Iran.
4
Description
Triglyceride (TG)
Timepoint
At the beginning of the study and six weeks after the start of the supplement and training.
Method of measurement
Using Hitachi 717 machine and kit made in Iran.
5
Description
Cholesterol
Timepoint
At the beginning of the study and six weeks after the start of the supplement and training.
Method of measurement
Using Hitachi 717 machine and kit made in Iran.
Intervention groups
1
Description
First intervention group: Consumption of beta-alanine supplement from My Protein company for six weeks in the amount of 6.4 grams daily in the form of 8 capsules of 0.8 grams (two capsules in each main meal) and performing three sessions of high-intensity interval training (10 one-minute intervals with 80% of maximum aerobic power and one-minute recovery with 20% of maximum aerobic power between intervals).
Category
Prevention
2
Description
Second intervention group: Consumption of beta-alanine supplement from My Protein company for six weeks in the amount of 6.4 grams daily in the form of 8 capsules of 0.8 grams (two capsules in each main meal).
Category
Prevention
3
Description
Third intervention group: Consumption of placebo (Dextrose) for six weeks in the amount of 6.4 grams daily in the form of 8 capsules of 0.8 grams (two capsules in each main meal) and performing three sessions of high-intensity interval training (10 one-minute intervals with 80% of maximum aerobic power and one-minute recovery with 20% of maximum aerobic power between intervals).
Category
Prevention
4
Description
Control group: Consumption of placebo (Dextrose) for six weeks in the amount of 6.4 grams daily in the form of 8 capsules of 0.8 grams (two capsules in each main meal)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Shahid Beheshti
Full name of responsible person
Mohamad Saber Ebrahimi Zarandi
Street address
Shahid Shahriari Square, Evin,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Fax
+98 21 2243 1607
Email
sportscience@sbu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Babak Shokri
Street address
Shahid Shahriari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2236
Email
b-shokri@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Shahid Beheshti
Proportion provided by this source
20
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
The University of Shahid Beheshti
Full name of responsible person
Mohamad Saber Ebrahimi Zarandi
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Exercise Physiology
Street address
Boys' dormitory of Shahid Beheshti University, Daneshjoo Blvd., Shahid Shahriari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5824
Email
m.ebrahimizarandi@mail.sbu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Mohamad Saber Ebrahimi Zarandi
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Exercise Physiology
Street address
Boys' dormitory of Shahid Beheshti University, Daneshjoo Blvd., Shahid Shahriari Square, Evin, Tehran
No. 1, Yas Building, South Nobahar, end of Aqdasiyeh, Azgol, Tehran
City
Tehran
Province
Tehran
Postal code
1696813665
Phone
+98 21 2990 5849
Email
afshar.jafari@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
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
Only primary and secondary data will be presented as an article.
When the data will become available and for how long
The access period starts six months after the results are published.
To whom data/document is available
The present research data will be available to researchers in academic and scientific institutions in the form of general statistical data, or people who are also engaged in the industry can apply for it after the publication of the article.
Under which criteria data/document could be used
The present study's data will be made available to others in the form of general statistics (without reference to the raw data of the subjects) with the researchers' permission.
From where data/document is obtainable
Applicants can contact me by phone, WhatsApp, or email.
What processes are involved for a request to access data/document
After contacting me and reviewing the request, it will be reviewed if necessary.