Energy MetabolismFatMaxxNCT04935983
Maximal Fat Oxidation During Exercise
A study testing High CHO and Low CHO in people with Energy Metabolism, run by Wageningen University at 1 site in Netherlands.
Trial summary
It is well known that, even in quite homogenous populations, inter-individual variability in fat oxidation during exercise, in particular MFO, is quite large. Individual factors like gender, body composition (lean mass) and fitness level do explain a substantial part of this variation. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Metabolism
- What is being tested?
- High CHO and Low CHO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2020to Apr 2022
- Phase
- Interventional
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy (self-reported)
- aged between 20 and 35
- BMI between 18.5 to 27 kg/m2
- Recreationally active, defined as minimal of 3 hours training per week, and a maximum of 10 hours a week
- The sport a participant is engaged in should be a game sport, endurance sport, or should at least contain a major endurance component. Examples of sports that can be included are: distance running, cycling, triathlon, crossfit, and game sports like soccer, rugby, handball, hockey,
- ○ For part 2 subjects should be used to prolonged cycling exercise
- Able to be present and participate at all test days and willing and able to follow prescribed interventions
Who cannot join
- Inactive (defined as <3 hours of training per week)
- Non-recreational athlete (>10 hours of training per week)
- active in a sport without a major endurance component
- Smokers, defined as someone who has smoked regularly in the previous year.
- Excessive alcohol consumption (i.e. more than 14 units for males per week; 7 units for females)
- Drug use
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- The more 'extreme' diets (like veganism, ketogenic diet, raw-food, carnivore diet etc.)
- Participation in another biomedical study possibly interfering with the study results within 1 month before the first study visit
- Inability to participate and/or complete the required measurements
- People working for the department of Human Nutrition and Health (including Master thesis students)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Division of Human Nutrition, Wageningen University
Wageningen, Gelderland, 6703 HA
Marco Mensink, MD, PhD, +31317482646, marco.mensink@wur.nl
Marco Mensink, PhD
About this study
Official title: Maximal Fat Oxidation During Exercise: Impact of Nutritional Status and Exhaustion
It is well known that, even in quite homogenous populations, inter-individual variability in fat oxidation during exercise, in particular MFO, is quite large. Individual factors like gender, body composition (lean mass) and fitness level do explain a substantial part of this variation. In addition, genetic factors do underlie differences between individuals. But also 'external factors' like nutritional status, i.e. a low or high carbohydrate (CHO) availability, and exhaustion are likely linked to maximal fat oxidation, due to alterations in substrate availability. The contribution of these external factors to alterations in substrate utilization is, as of yet, unknown.
This study aims to establish the impact of pre-exercise CHO availability and exhaustion on maximal fat oxidation (MFO \& FATmax) during exercise
Read the detailed description
Rationale: During exercise, energy expenditure increases dramatically, with exercise intensity as the single most important factor influencing substrate utilization. It is commonly reported that fat oxidation increases as exercise intensity increases, up to a certain point. At higher exercise intensities, fat oxidation declines quite rapidly, despite increased energy requirements, and carbohydrate becomes the predominant, and finally the only fuel source during (aerobic) exercise.
The maximal capacity of the human body to oxidize fat during exercise can quantitatively be described by the so-called 'MFO' and 'FATmax'. The MFO (maximal fat oxidation) is the highest absolute level of fat oxidation as expressed in gram per minute (g/min), while FATmax is the exercise intensity at which fat oxidation is highest (%VO2max or %HFmax). These concepts may have importance for endurance training and performance.
It is well known that, even in quite homogenous populations, inter-individual variability in fat oxidation, in particular MFO, is quite large. Individual factors like gender, body composition (lean mass) and fitness level do explain a substantial part of this variation. In addition, genetic factors do underlie differences between individuals. But also 'external factors' like nutritional status, i.e. a low or high carbohydrate (CHO) availability, and exhaustion are likely linked to maximal fat oxidation, due to alterations in substrate availability. The contribution of these external factors to alterations in substrate utilization is, as of yet, unknown.
Objective: The investigators aim to establish the impact of pre-exercise CHO availability and exhaustion on maximal fat oxidation (MFO \& FATmax) during exercise.
Study design: The study consist of two parts. In part I the impact of carbohydrate availability will be assessed, in part II the impact of exhaustion.
In part I (cross-over design) subjects will perform an graded exercise test to measure maximal fat oxidation ('fatmax test'). At one occasion with low CHO, the other time with high CHO. The order will be randomised. One week will be considered in between conditions.
In part II (single-arm intervention), subjects will do the graded exercise test twice on a single day, but now with an exhaustive exercise session ('training') of ~ 90 min in between, to induce exhaustion In both parts, the experimental testing will be preceded by a visit in which body composition is measured and subjects are familiarised to the test procedures. In addition, a physical activity questionnaire and a 3 day food record will be taken.
The graded exercise test is the so-called 'fatmax test' as described by Achten and Jeukendrup (2003). Participants start with a warming up at 95W (males) or 60 W (females), after which intensity will be increased every 3 min with 35 W, till exhaustion. Heart rate as well as oxygen consumption (VO2) and carbon dioxide production (VCO2) will be monitored, to obtain fat oxidation rates and maximal aerobic capacity.
Study population: The population of this study will consist of both males and females, aged 20 to 35, with a BMI of 18.5 to 27 kg/m2. A participant should be recreationally active, defined as minimal of 3 hours training per week, and a maximum of 10 hours a week. Their sports activity should have an endurance component Participant do not smoke and are healthy, and comply with the study procedures.
Intervention (treatment):
Part I: In this part of the study the pre-exercise availability of carbohydrates will be manipulated. Before measuring maximal fat oxidation during exercise, subjects will be randomly-assigned to a 36 hour period (i.e an afternoon, a single day plus a breakfast) of either a low CHO / high fat diet (~65 %en by fat) or an equal energy (isocaloric), high carbohydrate diet (~65 %en by CHO).
Part II: in this part the intervention is a 'training session' of 90 min at 60% Wmax, with every 15 min a high intensity bout of exercise of 2 min (90%Wmax). This is to simulate a training session, and induce exhaustion.
The day before the trials, participants have to refrain from exercise.
Main study parameters/endpoints: The main study parameters are the MFO and FATmax as assessed with indirect calorimetry (VO2, VCO2) during a graded exercise test (35W/ 3min protocol). In order to calculate MFO and FATmax, oxygen consumption (VO2) and CO2 production (VCO2) are measured. From these values the respiratory exchange ration (RER) can be calculated, and fat oxidation will be quantified according to the equations of Frayn.
- Conditions
- Energy Metabolism
- Being tested
- High CHO, Low CHO
- Keywords
- exercise, 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.
High CHOOther
Diet with high carbohydrate content
Low CHOOther
Diet with low carbohydrate content
| Study group | Role | What they receive |
|---|---|---|
| High CHO | Active comparator | High CHO diet for 36 h Receives: Other: High CHO |
| Low CHO | Experimental | Low CHO diet for 36 h Receives: Other: Low CHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal fat oxidation during exercise (MFO)
The main study parameter is maximal fat oxidation during exercise, expressed as MFO (g/min) as assessed during a graded exercise test (35W/ 3min protocol)
Measured: 36 hours
Relative intensity maximal fat oxidation during exercise ('Fatmax')
The second study parameter is the relative exercise intensity at which maximal fat oxidation during exercise occurs, expressed as nd FATmax (%) as assessed during a graded exercise test (35W/ 3min protocol)
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Sep 2020
- Primary completionDec 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935983
- Sponsor's protocol ID
- NL72841.081.20
- Acronym
- FatMaxx
- Status last verified
- Jun 2021
- First submitted
- 5 Mar 2020
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Fat Oxidation During Exercise: Impact of Nutritional Status and Exhaustion
- ClinicalTrials.gov ID
- NCT04935983
- Acronym / sponsor ID
- FatMaxx / NL72841.081.20
- Conditions
- Energy Metabolism
- Keywords
- exercise, fat oxidation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is well known that, even in quite homogenous populations, inter-individual variability in fat oxidation during exercise, in particular MFO, is quite large. Individual factors like gender, body composition (lean mass) and fitness level do explain a substantial part of this variation. In addition, genetic factors do underlie differences between individuals. But also 'external factors' like nutritional status, i.e. a low or high carbohydrate (CHO) availability, and exhaustion are likely linked to maximal fat oxidation, due to alterations in substrate availability. The contribution of these external factors to alterations in substrate utilization is, as of yet, unknown.
This study aims to establish the impact of pre-exercise CHO availability and exhaustion on maximal fat oxidation (MFO \& FATmax) during exercise
Detailed description
Rationale: During exercise, energy expenditure increases dramatically, with exercise intensity as the single most important factor influencing substrate utilization. It is commonly reported that fat oxidation increases as exercise intensity increases, up to a certain point. At higher exercise intensities, fat oxidation declines quite rapidly, despite increased energy requirements, and carbohydrate becomes the predominant, and finally the only fuel source during (aerobic) exercise.
The maximal capacity of the human body to oxidize fat during exercise can quantitatively be described by the so-called 'MFO' and 'FATmax'. The MFO (maximal fat oxidation) is the highest absolute level of fat oxidation as expressed in gram per minute (g/min), while FATmax is the exercise intensity at which fat oxidation is highest (%VO2max or %HFmax). These concepts may have importance for endurance training and performance.
It is well known that, even in quite homogenous populations, inter-individual variability in fat oxidation, in particular MFO, is quite large. Individual factors like gender, body composition (lean mass) and fitness level do explain a substantial part of this variation. In addition, genetic factors do underlie differences between individuals. But also 'external factors' like nutritional status, i.e. a low or high carbohydrate (CHO) availability, and exhaustion are likely linked to maximal fat oxidation, due to alterations in substrate availability. The contribution of these external factors to alterations in substrate utilization is, as of yet, unknown.
Objective: The investigators aim to establish the impact of pre-exercise CHO availability and exhaustion on maximal fat oxidation (MFO \& FATmax) during exercise.
Study design: The study consist of two parts. In part I the impact of carbohydrate availability will be assessed, in part II the impact of exhaustion.
In part I (cross-over design) subjects will perform an graded exercise test to measure maximal fat oxidation ('fatmax test'). At one occasion with low CHO, the other time with high CHO. The order will be randomised. One week will be considered in between conditions.
In part II (single-arm intervention), subjects will do the graded exercise test twice on a single day, but now with an exhaustive exercise session ('training') of ~ 90 min in between, to induce exhaustion In both parts, the experimental testing will be preceded by a visit in which body composition is measured and subjects are familiarised to the test procedures. In addition, a physical activity questionnaire and a 3 day food record will be taken.
The graded exercise test is the so-called 'fatmax test' as described by Achten and Jeukendrup (2003). Participants start with a warming up at 95W (males) or 60 W (females), after which intensity will be increased every 3 min with 35 W, till exhaustion. Heart rate as well as oxygen consumption (VO2) and carbon dioxide production (VCO2) will be monitored, to obtain fat oxidation rates and maximal aerobic capacity.
Study population: The population of this study will consist of both males and females, aged 20 to 35, with a BMI of 18.5 to 27 kg/m2. A participant should be recreationally active, defined as minimal of 3 hours training per week, and a maximum of 10 hours a week. Their sports activity should have an endurance component Participant do not smoke and are healthy, and comply with the study procedures.
Intervention (treatment):
Part I: In this part of the study the pre-exercise availability of carbohydrates will be manipulated. Before measuring maximal fat oxidation during exercise, subjects will be randomly-assigned to a 36 hour period (i.e an afternoon, a single day plus a breakfast) of either a low CHO / high fat diet (~65 %en by fat) or an equal energy (isocaloric), high carbohydrate diet (~65 %en by CHO).
Part II: in this part the intervention is a 'training session' of 90 min at 60% Wmax, with every 15 min a high intensity bout of exercise of 2 min (90%Wmax). This is to simulate a training session, and induce exhaustion.
The day before the trials, participants have to refrain from exercise.
Main study parameters/endpoints: The main study parameters are the MFO and FATmax as assessed with indirect calorimetry (VO2, VCO2) during a graded exercise test (35W/ 3min protocol). In order to calculate MFO and FATmax, oxygen consumption (VO2) and CO2 production (VCO2) are measured. From these values the respiratory exchange ration (RER) can be calculated, and fat oxidation will be quantified according to the equations of Frayn.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High CHO | Active comparator | Other: High CHOHigh CHO diet for 36 h |
| Low CHO | Experimental | Other: Low CHOLow CHO diet for 36 h |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Apparently healthy (self-reported)
- aged between 20 and 35
- BMI between 18.5 to 27 kg/m2
- Recreationally active, defined as minimal of 3 hours training per week, and a maximum of 10 hours a week
- The sport a participant is engaged in should be a game sport, endurance sport, or should at least contain a major endurance component. Examples of sports that can be included are: distance running, cycling, triathlon, crossfit, and game sports like soccer, rugby, handball, hockey,
Key exclusion criteria (10 listed)
- Inactive (defined as <3 hours of training per week)
- Non-recreational athlete (>10 hours of training per week)
- active in a sport without a major endurance component
- Smokers, defined as someone who has smoked regularly in the previous year.
- Excessive alcohol consumption (i.e. more than 14 units for males per week; 7 units for females)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High CHODiet with high carbohydrate content | Other | High CHO |
| Low CHODiet with low carbohydrate content | Other | Low CHO |
Primary outcome
Maximal fat oxidation during exercise (MFO)
Time frame: 36 hours
The main study parameter is maximal fat oxidation during exercise, expressed as MFO (g/min) as assessed during a graded exercise test (35W/ 3min protocol)
Relative intensity maximal fat oxidation during exercise ('Fatmax')
Time frame: 36 hours
The second study parameter is the relative exercise intensity at which maximal fat oxidation during exercise occurs, expressed as nd FATmax (%) as assessed during a graded exercise test (35W/ 3min protocol)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Division of Human Nutrition, Wageningen University
Wageningen, Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High CHO and Low CHO in people with Energy Metabolism, run by Wageningen University at 1 site in Netherlands.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 Jun 2021. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal fat oxidation during exercise (MFO) (time frame: 36 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2021.