Maximal Rate of Fat OxidationNCT02070055
Dietary Correlates of the Maximal Capacity for Fat Oxidation
An observational study of Maximal Rate of Fat Oxidation, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
There is a large variability in people's ability to burn fat during exercise. It is thought that differences in dietary intake can partly explain this variation, however this has not been comprehensively studied. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Maximal Rate of Fat Oxidation
- How many people
- 306 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Mar 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Local healthy population
Who may be able to join
- Age: 18 - 45 years of age
- Sex: Men and women*
- Women must be eumenorrheic and regularly menstruating or using hormonal contraception
- BMI: 18.8-29.9 kg/m2
- Diagnosis / General Health: Good general health and accustomed to normal levels of activity as assessed by the School of Sport and Exercise Sciences General Health Questionnaire
- Compliance: understands and is willing, able and likely to comply with all study procedures and restrictions.
- Consent: demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Who cannot join
- Women who are known to be pregnant
- Women who are breast feeding
- Current or recent (last 3 months) participation in another clinical or intervention trial.
- Concomitant Medication. Prescription or non-prescription medication that may interfere with metabolism or substrate utilisation (including beta-blockers, insulin, bronchodilators, anti-inflammatory agents, thyroxine and medications/supplements that in the opinion of the investigator may affect metabolism).
- Substance abuse (within the last 1 years)
- Completely sedentary individuals as assessed by the School of Sport and Exercise Sciences General Health Questionnaire
Show all 9Show fewer
- Consumption of alcohol 24 hours prior to Visit 2
- Current or recent (within the last 30 days) smoker
- Engaged in prolonged periods of food abstinence (e.g., for health or religious reasons) that may influence the normal metabolic response to exercise
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham
Birmingham, West Midlands, B15 2TT
About this study
Official title: Dietary Correlates of the Maximal Capacity for Fat Oxidation During Exercise in Males and Females.
There is a large variability in people's ability to burn fat during exercise. It is thought that differences in dietary intake can partly explain this variation, however this has not been comprehensively studied. This will be investigated by measuring participant's habitual diet and rates of fat oxidation during exercise, and look for associations between the two.
Read the detailed description
The capacity to oxidize (burn) fat as fuel for exercise may have important implications for health and performance. For example, increased fat oxidation could help to induce a negative fat balance and over time improve body composition. Furthermore, increasing the oxidation of fat could spare carbohydrate utilization during exercise which should improve endurance performance by preserving the bodies limited carbohydrate reserves for the latter stages of competition. Interestingly, there is substantial individual variation in the balance of fuels used for energy during exercise and in particular the maximal capacity to oxidize fat (MFO). Whilst habitual diet is known to affect the metabolic response to exercise, the influence of nutrition on the individual variability observed in maximal fat oxidation has not been comprehensively studied.
Therefore, the proposed investigation aims to build on current understanding of how various nutritional factors influence MFO during exercise. Based on previous small intervention studies, it is suspected that energy balance and macronutrient content or distribution may exert the strongest influence on MFO during exercise. Specifically, the main hypothesis would be that negative energy balance; higher fat intake and/or low carbohydrate intake would be the strongest positive influencer's of MFO. Nonetheless, the determination of an array of habitual and acute nutrient intake data in a relatively large cohort of healthy individuals will enable an insight into the influence of a comprehensive array of nutrients on MFO during exercise. With a greater understanding of the nutritional factors that influence MFO during exercise, new nutritional interventions can be designed to promote the oxidation of fat for improved health and performance.
- Conditions
- Maximal Rate of Fat Oxidation
- Being tested
- No intervention
- Keywords
- Maximal Rate of Fat Oxidation, Substrate Oxidation, Fat oxidation, Respiratory Exchange Ratio (RER), Exercise, indirect calorimetry, substrate crossover
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No treatment Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Maximal Fat Oxidation in grams per minute
To determine the extent to which the habitual diet influences the maximal rate of fat oxidation during exercise in healthy men and women
Measured: From any 10 second interval from a 30 minute exercise test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maximal Rate of Fat OxidationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, GlaxoSmithKline
- Responsible party
- Principal investigator, Gareth Fletcher, University of Birmingham
- Investigators
- Gareth A Wallis, Dr, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070055
- Sponsor's protocol ID
- RG_12-251
- Status last verified
- Jun 2014
- First submitted
- 6 Dec 2012
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fletcher G, Eves FF, Glover EI, Robinson SL, Vernooij CA, Thompson JL, Wallis GA. Dietary intake is independently associated with the maximal capacity for fat oxidation during exercise. Am J Clin Nutr. 2017 Apr;105(4):864-872. doi: 10.3945/ajcn.116.133520. Epub 2017 Mar 1.
PubMed 28251936
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Correlates of the Maximal Capacity for Fat Oxidation During Exercise in Males and Females.
- ClinicalTrials.gov ID
- NCT02070055
- Acronym / sponsor ID
- RG_12-251
- Conditions
- Maximal Rate of Fat Oxidation
- Keywords
- Maximal Rate of Fat Oxidation, Substrate Oxidation, Fat oxidation, Respiratory Exchange Ratio (RER), Exercise, indirect calorimetry, substrate crossover
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, GlaxoSmithKline
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Feb 2014 (estimated)
- 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.
There is a large variability in people's ability to burn fat during exercise. It is thought that differences in dietary intake can partly explain this variation, however this has not been comprehensively studied. This will be investigated by measuring participant's habitual diet and rates of fat oxidation during exercise, and look for associations between the two.
Detailed description
The capacity to oxidize (burn) fat as fuel for exercise may have important implications for health and performance. For example, increased fat oxidation could help to induce a negative fat balance and over time improve body composition. Furthermore, increasing the oxidation of fat could spare carbohydrate utilization during exercise which should improve endurance performance by preserving the bodies limited carbohydrate reserves for the latter stages of competition. Interestingly, there is substantial individual variation in the balance of fuels used for energy during exercise and in particular the maximal capacity to oxidize fat (MFO). Whilst habitual diet is known to affect the metabolic response to exercise, the influence of nutrition on the individual variability observed in maximal fat oxidation has not been comprehensively studied.
Therefore, the proposed investigation aims to build on current understanding of how various nutritional factors influence MFO during exercise. Based on previous small intervention studies, it is suspected that energy balance and macronutrient content or distribution may exert the strongest influence on MFO during exercise. Specifically, the main hypothesis would be that negative energy balance; higher fat intake and/or low carbohydrate intake would be the strongest positive influencer's of MFO. Nonetheless, the determination of an array of habitual and acute nutrient intake data in a relatively large cohort of healthy individuals will enable an insight into the influence of a comprehensive array of nutrients on MFO during exercise. With a greater understanding of the nutritional factors that influence MFO during exercise, new nutritional interventions can be designed to promote the oxidation of fat for improved health and performance.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Other: No interventionNo treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Local healthy population
Key inclusion criteria (7 listed)
- Age: 18 - 45 years of age
- Sex: Men and women*
- BMI: 18.8-29.9 kg/m2
- Diagnosis / General Health: Good general health and accustomed to normal levels of activity as assessed by the School of Sport and Exercise Sciences General Health Questionnaire
- Compliance: understands and is willing, able and likely to comply with all study procedures and restrictions.
Key exclusion criteria (9 listed)
- Women who are known to be pregnant
- Women who are breast feeding
- Current or recent (last 3 months) participation in another clinical or intervention trial.
- Concomitant Medication. Prescription or non-prescription medication that may interfere with metabolism or substrate utilisation (including beta-blockers, insulin, bronchodilators, anti-inflammatory agents, thyroxine and medications/supplements that in the opinion of the investigator may affect metabolism).
- Substance abuse (within the last 1 years)
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 |
|---|---|---|
| No intervention | Other | No treatment |
Primary outcome
Rate of Maximal Fat Oxidation in grams per minute
Time frame: From any 10 second interval from a 30 minute exercise test
To determine the extent to which the habitual diet influences the maximal rate of fat oxidation during exercise in healthy men and women
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
- Derived from this study: PubMed 28251936Fletcher G, Eves FF, Glover EI, Robinson SL, Vernooij CA, Thompson JL, Wallis GA. Dietary intake is independently associated with the maximal capacity for fat oxidation during exercise. Am J Clin Nutr. 2017 Apr;105(4):864-872. doi: 10.3945/ajcn.116.133520. Epub 2017 Mar 1.
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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.
Gareth A Wallis, Dr principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maximal Rate of Fat Oxidation, run by University of Birmingham at 1 site in United Kingdom.
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 9 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 13 Jun 2014. 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 United Kingdom. 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?
Rate of Maximal Fat Oxidation in grams per minute (time frame: From any 10 second interval from a 30 minute exercise 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 NCT02070055, which also lists 1 linked publication.
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 13 Jun 2014.