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Metabolic Thresholds and Fat Utilization Points Correlation (MATDFP)

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ClinicalTrials.gov Identifier: NCT03789045
Recruitment Status : Enrolling by invitation
First Posted : December 28, 2018
Last Update Posted : October 23, 2019
Sponsor:
Collaborators:
Aspire Medical
Appalachian State University
University of South Australia
University of Banja Luka
University of Ghent
University of Birmingham
Information provided by (Responsible Party):
Ratko Peric, Sport Studio Banja Luka

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.

Condition or disease Intervention/treatment
Exercise Physiology Diagnostic Test: Metabolic thresholds and fat oxidation points relationship

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: New Methodological Approach to Metabolic Thresholds Detection; Examining Fat Utilization Points and Metabolic Thresholds Correlation Strength
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Obese men
Metabolic thresholds and fat oxidation points relationship in Obese males, age 18-60y, body fat > 30%
Diagnostic Test: Metabolic thresholds and fat oxidation points relationship
Investigators aim to determine exercise intensity (expressed in ml/kg/min of VO2) 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.

Male athletes cyclists
Metabolic thresholds and fat oxidation points relationship in Athletic males, cyclist, age 18-60y, >12h of training weekly
Diagnostic Test: Metabolic thresholds and fat oxidation points relationship
Investigators aim to determine exercise intensity (expressed in ml/kg/min of VO2) 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.

Sedentary females
Metabolic thresholds and fat oxidation points relationship in Sedentary nonactive females, age 40-60y,
Diagnostic Test: Metabolic thresholds and fat oxidation points relationship
Investigators aim to determine exercise intensity (expressed in ml/kg/min of VO2) 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.

Moderately trained males
Metabolic thresholds and fat oxidation points relationship in moderately trained males, different sports, age 18-60y, < 3h of training weekly
Diagnostic Test: Metabolic thresholds and fat oxidation points relationship
Investigators aim to determine exercise intensity (expressed in ml/kg/min of VO2) 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.

Male athletes runners
Metabolic thresholds and fat oxidation points relationship in Athletic males, different sports, age 18-60y, >12h of training weekly
Diagnostic Test: Metabolic thresholds and fat oxidation points relationship
Investigators aim to determine exercise intensity (expressed in ml/kg/min of VO2) 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.




Primary Outcome Measures :
  1. Relationship between metabolic threshold and fat oxidation points [ Time Frame: Each primary outcome measure (metabolic thresholds and fat oxidation points expressed in ml/min/kg of VO2 ) is sampled continuously through the test. Test duration is 12-16 minutes.Existence of correlation will be evaluated immediately after test ]

    Examining correlation strength between exercise intensity (expressed in ml/min/kg of VO2) matching metabolic thresholds and fat oxidation points in different subjects.

    Metabolic thresholds will be determined via gas analysis using spiroergometry and fat oxidation points will be determined via gas analysis-indirect calorimetry.

    Exercise intensity at which metabolic thresholds and fat oxidation points occur will be expressed in VO2 (ml/min/kg).

    If determined, existing correlation can provide innovative additional method to determine metabolic thresholds as well as useful and practical exercise intensity marker if divergent group of subjects.

    Duration of the assessment test is between 12-16 minutes for each participant, depending on the subjects fitness level.

    Existence of correlation will be evaluated immediately after completion of the test by using MedCalc statistical software.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Athletic, moderately trained, sedentary and obese male and female residents of the city of Banja Luka
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789045


Locations
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Bosnia and Herzegovina
Sport Studio Banja Luka
Banja Luka, Bosnia and Herzegovina, 78000
Sponsors and Collaborators
Sport Studio Banja Luka
Aspire Medical
Appalachian State University
University of South Australia
University of Banja Luka
University of Ghent
University of Birmingham
Investigators
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Principal Investigator: Ratko Peric, Doctorate Sport Studio Banja Luka

Publications of Results:
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.

Other Publications:
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: 0 (0)- Pages: 1 - 8, 2019. https://doi.org/10.3920/CEP190035

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Responsible Party: Ratko Peric, Exercise Physiologist PhD, Sport Studio Banja Luka
ClinicalTrials.gov Identifier: NCT03789045     History of Changes
Other Study ID Numbers: 12345
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be made available upon request. Raw sampling data or statistical analysis data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ratko Peric, Sport Studio Banja Luka:
Exercise
Metabolic thresholds
Fat oxidation