Clinical trial NCT03789045: Metabolic Thresholds and Fat Utilization Points Correlation
Official title: New Methodological Approach to Metabolic Thresholds Detection; Examining Fat Utilization Points and Metabolic Thresholds Correlation Strength
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise Physiology
Keywords: Exercise
Metabolic thresholds
Fat oxidation
Lead sponsor: Sport Studio Banja Luka
Sponsor class: OTHER
Collaborators: name: Aspire Medical
name: Appalachian State University
name: University of South Australia
name: University Ghent
name: University of Birmingham
name: Stanford University
name: Cosmed USA, Inc.
name: University Hospital of Split
name: University of Urbino "Carlo Bo"
name: Universidad de Granada
name: Autonomous University of Ciudad Juarez
First posted: 2018-12-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletic, moderately trained, sedentary and obese males and females

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.

Detailed description: This study aims to examine the existence of connection between metabolic thresholds and fat oxidation points in diverse group of subjects. From the physiological perspective, during exercise with increasing intensity, three phases of the body's energy utilization and two threshold points can be defined. These threshold points have been named metabolic thresholds and as such are considered as indicators of exercise capacities. Several authors have suggested, that the first threshold should be called the 'aerobic threshold' (AeT) and the second the 'anaerobic threshold' (AnT). The energy contribution from fat oxidation increases during low-to-moderate exercise intensities and then markedly declines when the intensity becomes high, at which point carbohydrates (CHO) remain the dominant energy substrate. A term used to describe exercise intensity where fat oxidation reaches optimum, is maximal fat oxidation point (FATmax) whereas exercise intensity matching the negligible fat oxidation is labelled FATmin. During physical activity, due to limited availability of CHO, subjects are more dependent on energy originating from fat when aiming to optimize endurance performance, body composition, optimize weight control and the metabolic rate. Exercise at the intensity eliciting FATmax revealed best results in treatment and prevention of obesity-associated conditions, cardio-vascular and pulmonary diseases by means of increase in maximal fat oxidation rates (MFO), insulin sensitivity, improvements in ventilator efficiency and cardiac output, demonstrating a significant role in the treatment of these impairments. As a follow-up, studies demonstrated how the lowest beneficial effect was observed when exercise was performed above intensity matching negligible fat oxidation rate (FATmin), contributing to diminished protection of exercise therapy. In consequence, increased cardio-metabolic demands of exercise performed above FATmin also have a higher impact on mortality rates in comparison to low-moderate aerobic exercise. Therefore, choosing appropriate exercise intensity may play a decisive role in decreasing risk factors accompanying obesity-associated conditions.

Investigators aim to determine metabolic thresholds and fat oxidation points by using non-invasive breath-by-breath gas analysis during either treadmill or cycle ergometry. Metabolic thresholds will be detected by using gas analysis, via ventilatory parameters. Fat oxidation points will be determined using indirect calorimetry.

Participants will perform graded ergometry test (2min stages and 1km/h or 50 W load increase), on either cycle or treadmill ergometer, till exhaustion to determine maximal oxygen uptake (VO2max), with gases being collected at the mouth level by using spiroergometry.

The strength of the relationship between intensities matching VO2 at AeT and VO2 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.

Associated heart rate at the AeT/FATmax and AnT/FATmin will be used as training mean to identify proper training intensity.

The time frame of the study is about 3 years, depending on the availability of the subjects. Planed study begin is early 2016. Participants will be every day clients of the Institution and will be recruited on a voluntary basis as they arrive to the testing facilities through this 3 years period.Through this 3 years period, statistical analysis of the collected data for each group of subjects will be performed and observations will be published. Up to 7 publications are expected to result from this research.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Relationship between metabolic threshold and fat oxidation points (FATmax) matching %HRmax
timeFrame: 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:
measure: Relationship between metabolic threshold and fat oxidation points (FATmax) matching %VO2max
timeFrame: 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
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: Sport Studio Banja Luka
Study officials:
affiliation: Sport Studio Banja Luka
name: Ratko Peric, Doctorate
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.