NCT03789045

Brief Summary

To examine existence of connection between fat utilization points, both maximal and minimal with individual metabolic thresholds in different subjects. As a consequence, this innovative approach could offer a supplementary method for both aerobic and anaerobic thresholds detection as well as useful and practical exercise intensity selection marker.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

6.7 years

First QC Date

December 21, 2018

Last Update Submit

January 18, 2023

Conditions

Keywords

ExerciseMetabolic thresholdsFat oxidation

Outcome Measures

Primary Outcomes (1)

  • Relationship between metabolic threshold and fat oxidation points (FATmax) matching %HRmax

    Regular exercise at FATmax intensity has been proposed as a key factor to optimize the body's ability to oxidize lipids.Exercise intensity matching FATmax will be determined via indirect calorimetry and expressed by using %HRmax.In contrast to the %HRmax method, an individualized approach to exercise intensity prescription based on metabolic thresholds describes specific metabolic phases during exercise and intends to account for differences in the body's physiological and functional capacity.Metabolic thresholds will be determined via either gas analysis or/and lactate analysis and expressed in %HRmax.If connection between these two %HRmax exists,it would integrate the most relevant indices for planning and assessing an effective exercise program.Existence of connection between %HRmax matching both parameters will be evaluated by using correlation and levels of agreement by using MedCalc statistical software.

    Each primary outcome measure (metabolic thresholds and fat oxidation points, is sampled continuously through the test. Test duration is 12-16 minutes.Existence of correlation will be evaluated immediately after test

Secondary Outcomes (1)

  • Relationship between metabolic threshold and fat oxidation points (FATmax) matching %VO2max

    Each primary outcome measure (metabolic thresholds and fat oxidation points, is sampled continuously through the test. Test duration is 12-16 minutes. Existence of correlation will be evaluated immediately after test

Study Arms (3)

Obese men and women

Metabolic thresholds and fat oxidation points relationship in Obese males and females, age 18-60y, body fat \> 30%

Diagnostic Test: Metabolic thresholds and fat oxidation points relationship

Male and female athletes

Metabolic thresholds and fat oxidation points relationship in Athletic males and females, age 18-60y.

Diagnostic Test: Metabolic thresholds and fat oxidation points relationship

Sedentary females and males

Metabolic thresholds and fat oxidation points relationship in Sedentary females and males, age 18-60y,

Diagnostic Test: Metabolic thresholds and fat oxidation points relationship

Interventions

Investigators aim to determine exercise intensity at which metabolic thresholds and fat oxidation points occur by using non-invasive breath-by-breath gas analysis during either graded treadmill or cycle ergometry test (2min stages and 1km/h or 50 W load increase) till exhaustion to determine maximal oxygen uptake (VO2max), with gases being collected at the mouth level. The strength of the relationship between AeT and at FATmax will be assessed using the Pearson product moment (r) correlation coefficient with same being done for AnT and FATmin correlation. A coefficient of determination (R2) will be used to detect the proportion of existing variance. A paired t-test will be used to asses' differences between measured variables. Bland-altman will be used to determine levels of agreement.

Male and female athletesObese men and womenSedentary females and males

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Athletic, moderately trained, sedentary and obese males and females

You may qualify if:

  • Healthy
  • Non smokers
  • No evidence of any metabolic, pulmonary or cardiovascular diseases possibly affecting substrates utilization.
  • No presence of musculoskeletal injuries (Must be able to perform graded exercise test on a treadmill or a cycle ergometer).
  • Males and females, age 18-60, divided in following 4 groups: obese, sedentary, moderately trained, athletes.
  • For obese group of individuals, body fat \> 30%
  • For sedentary group of individuals, no physical activity in last 3 years
  • For athletic group of individuals, \> 12 h training per week
  • For moderately trained individuals. \< 3 h per week of physical activity
  • Willing to allow data publication.

You may not qualify if:

  • Evidence of any metabolic, pulmonary or cardiovascular diseases possibly affecting substrates utilization.
  • Smokers.
  • High blood pressure.
  • Using supplements possibly affecting substrates utilization.
  • Non willing to allow data publication.
  • Not finishing grade exercise test protocol till exhaustion to determine VO2max.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport Studio Banja Luka

Banja Luka, 78000, Bosnia and Herzegovina

Location

Related Publications (9)

  • Peric R, DI Pietro A, Myers J, Nikolovski Z. A systematic comparison of commonly used stoichiometric equations to estimate fat oxidation during exercise in athletes. J Sports Med Phys Fitness. 2021 Oct;61(10):1354-1361. doi: 10.23736/S0022-4707.20.11747-X. Epub 2020 Dec 14.

    PMID: 33314884BACKGROUND
  • Peric R, Meucci M, Nikolovski Z. Fat Utilization During High-Intensity Exercise: When Does It End? Sports Med Open. 2016 Dec;2(1):35. doi: 10.1186/s40798-016-0060-1. Epub 2016 Aug 31.

  • Peric R, Meucci M, Bourdon PC, Nikolovski Z. Does the aerobic threshold correlate with the maximal fat oxidation rate in short stage treadmill tests? J Sports Med Phys Fitness. 2018 Oct;58(10):1412-1417. doi: 10.23736/S0022-4707.17.07555-7. Epub 2017 Jul 25.

  • Meucci M, Peric R. Correlation Between Aerobic Threshold And Point Of Maximal Fat Utilization In Male Runners: 1678 Board #331 June 2, 8: 00 AM - 9: 30 AM. Med Sci Sports Exerc. 2016 May;48(5 Suppl 1):466-7. doi: 10.1249/01.mss.0000486403.83644.7e.

    RESULT
  • Peric R, Nikolovski Z. Can metabolic thresholds be used as exercise intensity markers in adult men with obesity - fat burn points used as an exercise marker. Comparative Exercise Physiology: 16 (2)- Pages: 113 - 119. https://doi.org/10.3920/CEP190035

    RESULT
  • Nikolovski Z, Barbaresi S, Cable T, Peric R. Evaluating the influence of differences in methodological approach on metabolic thresholds and fat oxidation points relationship. Eur J Sport Sci. 2021 Jan;21(1):61-68. doi: 10.1080/17461391.2020.1717640. Epub 2020 Jan 31.

  • Meucci M, Nandagiri V, Kavirayuni VS, Whang A, Collier SR. Correlation Between Heart Rate at Maximal Fat Oxidation and Aerobic Threshold in Healthy Adolescent Boys and Girls. Pediatr Exerc Sci. 2021 May 6;33(3):139-143. doi: 10.1123/pes.2020-0210.

  • Peric R, Nikolovski Z, Meucci M, Tadger P, Ferri Marini C, Amaro-Gahete FJ. A Systematic Review and Meta-Analysis on the Association and Differences between Aerobic Threshold and Point of Optimal Fat Oxidation. Int J Environ Res Public Health. 2022 May 26;19(11):6479. doi: 10.3390/ijerph19116479.

  • Ferri Marini C, Tadger P, Chavez-Guevara IA, Tipton E, Meucci M, Nikolovski Z, Amaro-Gahete FJ, Peric R. Factors Determining the Agreement between Aerobic Threshold and Point of Maximal Fat Oxidation: Follow-Up on a Systematic Review and Meta-Analysis on Association. Int J Environ Res Public Health. 2022 Dec 27;20(1):453. doi: 10.3390/ijerph20010453.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ratko Peric, Doctorate

    Sport Studio Banja Luka

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Exercise Physiologist PhD

Study Record Dates

First Submitted

December 21, 2018

First Posted

December 28, 2018

Study Start

May 1, 2016

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations