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Trial details
Changes of Resting Metabolic Rate in University Athletes
Current status:
Approved
|
Date registered:
23/05/2022
Trial version(s)
Current: 14/03/2022
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Main Information
Primary registry identifying number
LBCTR2022035012
Protocol number
BIO-2021-0404
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Lebanon
Type of registration
Prospective
Date of registration in national regulatory agency
10/02/2022
Primary sponsor
University Research Board (URB), American University of Beirut (AUB)
Primary sponsor: Country of origin
Lebanon
Public title
Changes of Resting Metabolic Rate in University Athletes
Acronym
Scientific title
Changes of Resting Metabolic Rate in University Athletes
Acronym
Brief summary of the study: English
Resting Metabolic Rate (RMR), which is the energy required to sustain normal body functions, has been extensively used in the literature to establish the daily caloric requirements of athletes. However, research has mostly focused on high-intensity athletes, mainly rugby players. Therefore, in this study we aim to broaden our scope of RMR measurements among various athletes to determine the caloric requirements of different sports activities. AUB has 28 sports teams and athletes from each sports category will be invited to participate in this study where RMR will be measured by Indirect Calorimetry before, during, and after games or competitions. Three teams will be chosen, and 17 participants will be recruited from each team. Considering the game day to be at day (0), the first measurement will take place before the game day (-1), then on the day after the game day (+1), and the third measurement will be 3 days after the game day (+3). The generated data from this study will provide valuable information to optimize the performance of athletes throughout tournaments by tailoring their nutritional needs. There are four additional aims in the study, including the assessment of participants' hydrational status, amount of exercise, external demands, and dietary intake.
Brief summary of the study: Arabic
عادة، يتم استخدام معدل الأيض الأساسي لتحديد السعرات الحرارية اليومية التي يحتاجها الرياضيون. معدل الأيض الأساسي هو الطاقة المطلوبة للحفاظ على وظائف الجسم الطبيعية. غالبا ما تركز الأبحاث على دراسة اللاعبين في الرياضات العالية الكثافة، وخاصة رياضة كرة القدم الأمريكية (الركبي) . لذلك، الهدف من هذه الدراسة هو توسيع نطاق قياس معدل الأيض الأساسي ليشمل مختلف الرياضيين، والتالي تحديد السعرات الحرارية المطلوبة للأنشطة الرياضية المختلفة. تضم الجامعة الأميركية في بيروت 28 فريقًا رياضيًا. سيتم إختيار ثلاثة فرق، وسيتم إستقطاب 17 لاعب من كل فريق للمشاركة في هذه الدراسة، حيث سيتم قياس معدل الأيض الأساسي بواسطة المسعرية غير المباشرة، قبل،أثناء وبعد المباريات أو المسابقات. سيتم إعتبار أن يوم المبارة هو اليوم (صفر)، وبالتالي، سيتم قياس معدل الأيض الأساسي في اليوم الذي يسبق يوم المباراة أي اليوم (-1)، ثم في اليوم الذي يلي يوم المباراة (+1)، وفي اليوم الثالث بعد المباراة (+3). سنحصل من خلال هذه الدراسة على معلومات هامة من شأنها المساعدة في تحسين أداء اللاعبين أثناء المباريات، عبر تكييفها مع إحتياجاتهم الغذائية. هناك أربعة أهداف إضافية لهذه الدراسة، وهي تقييم مستوى الترطيب للمشاركين ، التمرين الرياضي ، المتطلبات الخارجية ، والكمية الغذائية.
Health conditions/problem studied: Specify
Subjects are athletes at the American University of Beirut. No health conditions being studied.
Interventions: Specify
Resting metabolic rate of participants will be measured after being fasted for 8h.They will undergo 15 minutes enforced rest period before starting the 15 minutes assessment where they will need to sit in an adjustable, ergonomic car seat, to measure their RMR via Indirect Calorimetry machine. Urine samples will be collected from participants in the morning (1st void) to assess Urine color and Urine Specific Gravity (USG). They will be asked to wear an accelerometer for 1 week to record their external demands. Multiple 24-hour dietary recalls will be performed to gather data about their food and beverages consumption to assess energy and nutrient intake of the diet.
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion criteria: AUB athletes, males, ages between 18 and 35 years, with a normal body mass index (BMI).
Key inclusion and exclusion criteria: Gender
Male
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
35
Key inclusion and exclusion criteria: Exclusion criteria
Subjects are excluded if they are injured or have a previous history of any limitation on physical ability, diabetes, cardiovascular disease, taking supplements or medicine that might affect their metabolic rate, claustrophobic or having unstable bodyweight during the past 6 months.
Type of Study
Type
Interventional
Type of intervention
Dietary interventions
Trial scope
Other
Trial scope: Specify scope
Performance
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
N/A
Study design: Purpose
Basic science
Study design: Assignment
Single
Pharmaceutical class
No pharmaceutical product
Therapeutic indication
No therapeutic indication
Therapeutic benefit
The outcome of this study will provide insights on athletes’ energy requirements for better performance during competition and recovery. Findings of this study will provide more insight in tailoring nutritional needs/requirements to the unique metabolic demands of athletes.
Biospecimen retention
Samples without DNA
Biospecimen description
Urine samples will be collected to assess Urine Specific Gravity and Urine color.
Target sample size
51
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
15/03/2022
Date of study closure: Type
Anticipated
Date of study closure: Date
30/04/2022
Recruitment status
Pending
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
No IPD sharing statement plan
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
N/A
N/A
Sources of Monetary or Material Support
Name
University Review Board (URB) at Amercian University of Beirut (AUB)
Secondary Sponsors
Name
N/A
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Elie-Jacques
Fares
Department of Nutrition and Food Sciences, Faculty of Agricultural and Food Sciences, American University of Beirut
Lebanon
+96179195509
ef08@aub.edu.lb
AUB
Scientific
Elie-Jacques
Fares
Department of Nutrition and Food Sciences, Faculty of Agricultural and Food Sciences, American University of Beirut
Lebanon
+96179195509
ef08@aub.edu.lb
AUB
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
N/A
N/A
N/A
NA
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
10/02/2022
Karine Ismail
irb@aub.edu.lb
Tel:+961-1-738024 or +961-1-350000 ext: 5591
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
N/A
2-Propanol (T51.2)
N/A
Interventions
Intervention
Description
Keyword
Resting metabolic rate measurement of athletes
Resting metabolic rate of participants will be measured after being fasted for 8h.They will undergo 15 minutes enforced rest period before starting the 15 minutes assessment where they will need to sit in an adjustable, ergonomic car seat, to measure their RMR via Indirect Calorimetry machine. Urine samples will be collected from participants in the morning (1st void) to assess Urine color and Urine Specific Gravity (USG). They will be asked to wear an accelerometer for 1 week to record their external demands. Multiple 24-hour dietary recalls will be performed to gather data about their food and beverages consumption to assess energy and nutrient intake of the diet.
Resting metabolic rate, external demands, 24-hour dietary recall
Primary Outcomes
Name
Time points
Measure
Resting metabolic rate
Before, during and after games
RMR
Key Secondary Outcomes
Name
Time points
Measure
Hydration Status
game day, 1 day after game day
Urine Specific Gravity, Urine color
External demands
During 7 days
Accelerometer
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial