Metabolic Thresholds and Fat Utilization Points Correlation (MATDFP)

January 18, 2023 updated by: Ratko Peric, Sport Studio Banja Luka

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Athletic, moderately trained, sedentary and obese males and females

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between metabolic threshold and fat oxidation points (FATmax) matching %VO2max
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sport Studio Banja Luka

Collaborators

Stanford University
University Ghent
Appalachian State University
University of Birmingham
Universidad de Granada
University Hospital of Split
University of South Australia
University of Urbino "Carlo Bo"
Aspire Medical
Cosmed USA, Inc.
Autonomous University of Ciudad Juarez

Investigators

  • Principal Investigator: Ratko Peric, Doctorate, Sport Studio Banja Luka

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

December 21, 2018

First Submitted That Met QC Criteria

December 25, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12345 (Danish Center for Healthcare Improvements)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

IPD will be made available upon request. Raw sampling data or statistical analysis data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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