- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07548515
Understanding the Relationship of Body Composition and Metabolism in Adult and Older Filipino Endurance and Strength Athletes in the Philippines (NPOWER P1)
Understanding the Relationship of Body Composition and Metabolism in Adult and Older Filipino Endurance and Strength Athletes in the Philippines (NPOWER P1)
Study Overview
Status
Detailed Description
The general objective of the study is to conduct fundamental researches in nutrition physiology among Filipino athletes in selected sports through evaluation of their body composition, metabolism, nutritional status, aerobic capacity, and physical performance using validated assessment tools. Specifically, the study aims to:
- Compare the body composition of Filipino athletes and age- and sex-matched non-athletes using bioelectrical impedance analysis (BIA), dual-energy X-ray absorptiometry (DXA), air displacement plethysmography (ADP), muscle ultrasound and deuterium dilution technique;
- Assess and compare the metabolism via resting and activity energy expenditure, nutritional status, dietary intake, and aerobic capacity of Filipino athletes and age- and sex-matched non-athletes using indirect calorimetry techniques, anthropometric measurements, food diaries, VO₂max measurement, lactic acid threshold, and Incremental Step Test;
- Determine the association of body composition, metabolism, and aerobic capacity among adults and senior citizen athletes partaking in recreational sports; and
- Analyze the relationship of nutritional status and metabolism with physical performance indicators among adults and senior citizen athletes partaking in recreational sports.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ma. Lourdes T. Cumagun
- Phone Number: local 306 8837-8113 to 14
- Email: maloucumagun@yahoo.com
Study Contact Backup
- Name: Robby Carlo A. Tan, Msc
- Phone Number: local 306 8837-8113 to 14
- Email: robbycarlo.tan@wur.nl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria (Athletes):
- Male or female athletes aged 20-40 (early and mid-adults) and 60-69 (older adults)
- Natural-born Filipinos with maternal and paternal Filipino heritage
- Current and former national and professional athletes, actively participating in endurance or strength sports events or recreational sports events
- Current off-season athletes undergoing training or former professional athletes who played <3 years ago
- With ≥3 years of formal, structured athletic training
- Apparently healthy (no cardiovascular conditions, respiratory diseases, musculoskeletal disorders, neurological conditions and metabolic disorders)
- Ambulatory and can perform physical activity exercises such as treadmill walking/running and stationary bike
- Cleared by a physician to participate in exercise testing; for older adults, clearance must be based on electrocardiogram (ECG) results.
Inclusion Criteria (Non-Athletes):
- Age (+3 years) and sex-matched community-dwelling participants
- Natural-born Filipinos with maternal and paternal Filipino heritage
- Not involved in structured or competitive exercise training
- Apparently healthy (no cardiovascular conditions, respiratory diseases, musculoskeletal disorders, neurological conditions and metabolic disorders)
- Ambulatory and can perform physical activity exercises such as treadmill walking/running and stationary bike
- Cleared by a physician to participate in exercise testing; for older adults, clearance must be based on electrocardiogram (ECG) results.
Exclusion Criteria (Athletes and Non-Athletes):
- Unable to comprehend and answer the questions
- Presence of metal implants and/or pacemaker
- Has limited mobility and a history of orthopedic surgery (that may limit their mobility)
- With medically diagnosed severe diseases that could affect body composition or metabolism (i.e., cardiovascular diseases, diabetes, cancer, renal diseases, thyroid disorders)
- Experienced minor or major injury in the past 3 months that will inhibit the performance
- Taking prohibited sports substances banned by the World Anti-Doping Program that may influence the performance of exercise
- Taking medications that can affect metabolism (e.g., mood stabilizers, GLP-1 receptor agonists etc.)
- Current smoker or Electronic Nicotine Delivery System (ENDS; vape, e-cigarette) smoker
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Athletes
Strength and Endurance Athletes
|
|
Non-athletes
Community-dwelling participants
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat Mass in kilograms and percentage
Time Frame: The expected period of the collection per participant is 3 days.
|
Fat mass will be measured using the Bioelectric Impedance Analyzer (BIA), the Dual X-ray absorptiometry (DXA) Machine, Deuterium Dilution Technique (DDT), ultrasound technology, and air displacement method.
|
The expected period of the collection per participant is 3 days.
|
|
Fat-Free Mass in kilograms and percentage
Time Frame: The expected period of the collection per participant is 3 days.
|
Fat-free mass will be measured using the Bioelectric Impedance Analyzer (BIA), the Dual X-ray absorptiometry (DXA) Machine, Deuterium Dilution Technique (DDT), ultrasound technology, and air displacement method.
|
The expected period of the collection per participant is 3 days.
|
|
Resting Metabolic Rate in kilocalories per day
Time Frame: The expected period of the collection per participant is 3 days.
|
Resting Metabolic Rate Energy expenditure at rest will be measured using an indirect calorimeter (COSMED Fitmate, Rome, Italy) in the fasting state (10-12 hours).
|
The expected period of the collection per participant is 3 days.
|
|
Activity Energy Expenditure in kilocalories
Time Frame: The expected period of the collection per participant is 3 days.
|
Active energy expenditure will be measured using an indirect calorimeter (COSMED K5). They will follow an Incremental Step Test using a cycle ergometer. The participants will be assisted by a researcher during the familiarization phase wherein the KOPS Approach and Familiarization to the equipment will be held. The KOPS Approach must have their legs at least right angle, knees and arms should not be over extended. Make sure that the feet of participants are sealed onto the pedal pads. Participants will be instructed to maintain a pedaling rate of 40-60 revolutions per minute (rpm). Each stage of the test will last three minutes, with the workload increasing progressively until the participant reaches fatigue or test termination |
The expected period of the collection per participant is 3 days.
|
|
Aerobic Capacity in mL/kg/min
Time Frame: The expected period of the collection per participant is 3 days.
|
Aerobic capacity will be measured using an incremental step test in an ergocycle.
|
The expected period of the collection per participant is 3 days.
|
|
Blood Lactate Concentration in mmol/L during exercise
Time Frame: The expected period of the collection per participant is 3 days.
|
Lactate levels will be measured at baseline, during the conducted of incremental step test (during stage 3 and stage 5), and during the cool down period.
20 uL of blood will be collected through finger-prick.
|
The expected period of the collection per participant is 3 days.
|
|
Handgrip strength in kilograms
Time Frame: The expected period of the collection per participant is 3 days.
|
A hydraulic hand dynamometer will be used as an objective instrument for grip strength.
|
The expected period of the collection per participant is 3 days.
|
|
Leg strength in Newton-meter
Time Frame: The expected period of the collection per participant is 3 days.
|
An isokinetic dynamometer will be utilized to measure leg strength, precisely that of the quadriceps muscle.
This will be assessed using maximal voluntary contraction (MVC) of the knee extensors using an isokinetic dynamometer.
|
The expected period of the collection per participant is 3 days.
|
|
Speed of participants in kilometers per hour
Time Frame: The expected period of the collection per participant is 3 days.
|
To assess the speed of young athletes and non-athletes, the study will use the Beep Test.
In this test, participants run back and forth between two cones placed 20 meters apart, following the pace set by audio "beep" sounds.
Divided into 21 levels, with each level lasting about 1 minute.
The running speed starts at 8.5 km/h and gradually increases by 0.5 km/h at every making the test more challenging as it progresses.
|
The expected period of the collection per participant is 3 days.
|
|
Dietary Intake in kilocalories or grams per day
Time Frame: The expected period of the collection per participant is 3 days.
|
The participants' dietary intake for two non-consecutive days (one weekday and one weekend) before the data collection will be collected using a food record (FR).
For athletes, it is preferable that one training day will be reflected in their FR but only when it coincides with the scheduled activities; otherwise, this is not required.
Average daily energy, protein, carbohydrates, and fats intake will be reported.
|
The expected period of the collection per participant is 3 days.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ma. Lourdes T. Cumagun, Department of Science and Technology - Food and Nutrition Research Institute (DOST-FNRI)
Publications and helpful links
General Publications
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- Strasser B, Pesta D, Rittweger J, Burtscher J, Burtscher M. Nutrition for Older Athletes: Focus on Sex-Differences. Nutrients. 2021 Apr 22;13(5):1409. doi: 10.3390/nu13051409.
- Santos DA, Dawson JA, Matias CN, Rocha PM, Minderico CS, Allison DB, Sardinha LB, Silva AM. Reference values for body composition and anthropometric measurements in athletes. PLoS One. 2014 May 15;9(5):e97846. doi: 10.1371/journal.pone.0097846. eCollection 2014.
- Roh J, Rhee J, Chaudhari V, Rosenzweig A. The Role of Exercise in Cardiac Aging: From Physiology to Molecular Mechanisms. Circ Res. 2016 Jan 22;118(2):279-95. doi: 10.1161/CIRCRESAHA.115.305250.
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- Raguso CA, Kyle U, Kossovsky MP, Roynette C, Paoloni-Giacobino A, Hans D, Genton L, Pichard C. A 3-year longitudinal study on body composition changes in the elderly: role of physical exercise. Clin Nutr. 2006 Aug;25(4):573-80. doi: 10.1016/j.clnu.2005.10.013. Epub 2005 Dec 5.
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- Kim CH, Wheatley CM, Behnia M, Johnson BD. The Effect of Aging on Relationships between Lean Body Mass and VO2max in Rowers. PLoS One. 2016 Aug 1;11(8):e0160275. doi: 10.1371/journal.pone.0160275. eCollection 2016.
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- Concannon LG, Grierson MJ, Harrast MA. Exercise in the older adult: from the sedentary elderly to the masters athlete. PM R. 2012 Nov;4(11):833-9. doi: 10.1016/j.pmrj.2012.08.007.
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- Chatindiara, I., Williams, V., Sycamore, E., Richter, M., Allen, J., & Wham, C. Associations between nutrition risk status, body composition and physical performance among community-dwelling older adults. Australian and New Zealand Journal of Public Health. 2019;43(1), 56-62. https://doi.org/10.1111/1753-6405.12848
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- Blanco, D. V. Sports governance stakeholders, actors and policies in the Philippines: Current issues, challenges and future directions. Asia Pacific Journal of Sport and Social Science,. 2016;5(3), 165-186.
- Betik AC, Hepple RT. Determinants of VO2 max decline with aging: an integrated perspective. Appl Physiol Nutr Metab. 2008 Feb;33(1):130-40. doi: 10.1139/H07-174.
- Baker, J., Fraser-Thomas, J., Dionigi, R. A., & Horton, S. Sport participation and positive development in older persons. European review of aging and physical activity. 2010;7(1), 3-12.
- Ackland TR, Lohman TG, Sundgot-Borgen J, Maughan RJ, Meyer NL, Stewart AD, Muller W. Current status of body composition assessment in sport: review and position statement on behalf of the ad hoc research working group on body composition health and performance, under the auspices of the I.O.C. Medical Commission. Sports Med. 2012 Mar 1;42(3):227-49. doi: 10.2165/11597140-000000000-00000.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FIERC-2025-019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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