NCT02070055

Brief 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. This will be investigated by measuring participant's habitual diet and rates of fat oxidation during exercise, and look for associations between the two.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2012

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 13, 2014

Status Verified

June 1, 2014

Enrollment Period

1.2 years

First QC Date

December 6, 2012

Last Update Submit

June 12, 2014

Conditions

Maximal Rate of Fat Oxidation

Keywords

Maximal Rate of Fat OxidationSubstrate OxidationFat oxidationRespiratory Exchange Ratio (RER)Exerciseindirect calorimetrysubstrate crossover

Outcome Measures

Primary Outcomes (1)

  • 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

    From any 10 second interval from a 30 minute exercise test

Study Arms (1)

No treatment

No treatment

Other: No intervention

Interventions

No interventionOTHER
No treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Local healthy population

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 28251936DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Gareth A Wallis, Dr

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Researcher

Study Record Dates

First Submitted

December 6, 2012

First Posted

February 24, 2014

Study Start

January 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 13, 2014

Record last verified: 2014-06

Locations

GB(1)