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Exercise PhysiologyMATDFPNCT03789045

Metabolic Thresholds and Fat Utilization Points Correlation

An observational study of Exercise Physiology, run by Sport Studio Banja Luka at 1 site in Bosnia and Herzegovina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Exercise Physiology
What is being tested?
Metabolic thresholds and fat oxidation points relationship
How many people
250 participants
Where
1 siteBosnia and Herzegovina
Study dates
1 May 2016to 30 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Athletic, moderately trained, sedentary and obese males and females

Who may be able to join

  • 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%
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Bosnia and Herzegovina1 site
  • Sport Studio Banja Luka

    Banja Luka, 78000

Other trials in Bosnia and Herzegovina

About this study

Official title: New Methodological Approach to Metabolic Thresholds Detection; Examining Fat Utilization Points and Metabolic Thresholds Correlation Strength

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.

Read the 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.

Being tested
Metabolic thresholds and fat oxidation points relationship
Keywords
Exercise, Metabolic thresholds, Fat oxidation
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metabolic thresholds and fat oxidation points relationshipDiagnostic test

    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.

Study groups in NCT03789045
Study groupRoleWhat they receive
Obese men and womenMetabolic thresholds and fat oxidation points relationship in Obese males and females, age 18-60y, body fat > 30%
Receives: Diagnostic Test: Metabolic thresholds and fat oxidation points relationship
Male and female athletesMetabolic thresholds and fat oxidation points relationship in Athletic males and females, age 18-60y.
Receives: Diagnostic Test: Metabolic thresholds and fat oxidation points relationship
Sedentary females and malesMetabolic thresholds and fat oxidation points relationship in Sedentary females and males, age 18-60y,
Receives: Diagnostic Test: Metabolic thresholds and fat oxidation points relationship

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Relationship between metabolic threshold and fat oxidation points (FATmax) matching %VO2max

    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 %VO2max.In contrast to the %VO2max 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 %VO2max.If connection between these two %VO2max exists, it would integrate the most relevant indices for planning and assessing an effective exercise program.Existence of connection between %VO2max matching both parameters will be evaluated by using correlation and levels of agreement by using MedCalc statistical software.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2018
  2. Study start1 May 2016
  3. Primary completion30 Dec 2022
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03789045
Sponsor's protocol ID
12345
Acronym
MATDFP
Status last verified
Jan 2023
First submitted
21 Dec 2018
Last updated
20 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD will be made available upon request. Raw sampling data or statistical analysis data

Publications

  • 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.

    PubMed 33314884
  • 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.

    PubMed 27747790
  • 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.

    PubMed 28745473
  • Peric R, Nikolovski Z, Meucci M P-25 Substrates oxidation at high intensity exercise in sedentary females Br J Sports Med 2016;50:A45. DOI: 10.1136/bjsports-2016-097120.78

  • 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.

  • 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

  • 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.

    PubMed 31944160
  • 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.

    PubMed 33958504
  • 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.

    PubMed 35682065
  • 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.

    PubMed 36612784

Questions about this trial

What is this clinical trial studying?

An observational study of Exercise Physiology, run by Sport Studio Banja Luka at 1 site in Bosnia and Herzegovina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relationship between metabolic threshold and fat oxidation points (FATmax) matching %HRmax (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03789045, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.

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