Protocol summary

Summary
The aim of this study is to investigation of the relationship between serum levels of lactate and glucose whit oxygen saturation, maximal heart rate and VO2max in response to L-carnitine consumption during exhaustive exercise in young active men. Sixteen young men participate in this study. The subjects continuously add to the research and assignment is crossover in intervention giving (Supplement and Placebo); So that subsequently randomly divide in to equal number group involved Placebo and supplement (3gr L-carnitine). After the one week wash-out process, the location of the subjects of each group chanced with another group. The subjects perform two sessions of the Bruce test. Serum levels of lactate, glucose, oxygen saturation (%SO2), maximal heart rate and VO2max register at before, immediately and 4min after the exhaustive exercise.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017051533979N1
Registration date: 2017-08-26, 1396/06/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-26, 1396/06/04
Registrant information
Name
Mohsen Shabani
Name of organization / entity
Shahid Rajaee Teacher Training University
Country
Iran (Islamic Republic of)
Phone
+98 21 7784 6518
Email address
m.shabani1986@srttu.edu
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-11-30, 1395/09/10
Expected recruitment end date
2016-12-15, 1395/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of lactate and serum glucose changes with oxygen saturation, heart rate and VO2max in response to the consumption of L-carnitine and placebo during exhaustive exercise in active young men
Public title
Sport Nutrition
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: Male; Young; Physical health; Active in terms of physical activity and sports; Accommodation in a dormitory (to control nutritional conditions). Exclusion criteria: Having a history of cardiovascular and respiratory diseases; L-carnitine supplementation usage during a month before the start of the test.
Age
From 24 years old to 27 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Rajaee Teacher Training University
Street address
Shabanloo St, Lavizan
City
Tehran
Postal code
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
SRTTU.SSF.1396.1100

Health conditions studied

1

Description of health condition studied
Consumption of L-Carnitine during Exhaustive Exercise
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Lactate
Timepoint
Before, Immediately and 4 min after the Bruce test
Method of measurement
By Lactometer

2

Description
Glucose
Timepoint
Before, Immediately and 4 min after the Bruce test
Method of measurement
By Glucometer

3

Description
Maximal Heart Rate (HRmax)
Timepoint
Immediately and 4 min after the Bruce test
Method of measurement
By Oximeter

4

Description
Oxygen Saturation (%SO2)
Timepoint
Before, Immediately and 4 min after the Bruce test
Method of measurement
By Oximeter

5

Description
Maximal Oxygen Consumption (VO2max)
Timepoint
Immediately after the Bruce test
Method of measurement
Calculated by Bruce test and Formula

Secondary outcomes

empty

Intervention groups

1

Description
Giving L-carnitine supplement (3gr) along with solution of water (200gr) and a few drops lemon juice, at 90 minutes before Bruce graded exercise test on treadmill. Velocity and incline Increase in treadmill gradually and simultaneously so that initial incline is 10% and, incline increases 2% per 3 minutes until exhaustion. (in supplement group)
Category
Other

2

Description
Giving placebo that includes solution of water (200gr) and a few drops lemon juice, at 90 minutes before Bruce graded exercise test on treadmill. Velocity and incline Increase in treadmill gradually and simultaneously so that initial incline is 10% and, incline increases 2% per 3 minutes until exhaustion. (in placebo group)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Sports Science, Shahid Rajaee Teacher Training University
Full name of responsible person
Dr. Majid Kashef, Professor in Exercise Physiology
Street address
Shahid Shabanloo St, Lavizan
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Rajaee Teacher Training University
Full name of responsible person
Saied Olyaee
Street address
Shahid Shabanloo St, Lavizan
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Rajaee Teacher Training University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Rajaee Teacher Training University
Full name of responsible person
Mohsen Shabani
Position
PhD student of Exercise Physiology
Other areas of specialty/work
Street address
Shahid Shabanloo St, Lavizan
City
Tehran
Postal code
1678815811
Phone
+98 21 2297 0055
Fax
Email
m.shabani1986@srttu.edu
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Rajaee Teacher Training University
Full name of responsible person
Mohsen Shabani
Position
PhD Student of Exercise Physiology (Neuromuscular)
Other areas of specialty/work
Street address
Shahid Shabanloo St, Lavizan
City
Tehran
Postal code
1678815811
Phone
+98 21 2297 0055
Fax
Email
m.shabani1986@srttu.edu
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Rajaee Teacher Training University
Full name of responsible person
Mohsen Shabani
Position
PhD Student of Exercise Physiology (Neuromuscular)
Other areas of specialty/work
Street address
Shahid Shabanloo St, Lavizan
City
Tehran
Postal code
1678815811
Phone
+98 21 2297 0055
Fax
Email
m.shabani1986@srttu.edu
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...