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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02070055
Other study ID # RG_12-251
Secondary ID
Status Completed
Phase N/A
First received December 6, 2012
Last updated June 12, 2014
Start date January 2013
Est. completion date March 2014

Study information

Verified date June 2014
Source University of Birmingham
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Research Ethics Service
Study type Observational

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 306
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

1. Age: 18 - 45 years of age

2. Sex: Men and women*

* Women must be eumenorrheic and regularly menstruating or using hormonal contraception

3. BMI: 18.8-29.9 kg/m2

4. 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

5. Compliance: understands and is willing, able and likely to comply with all study procedures and restrictions.

6. 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.

Exclusion Criteria:

1. Women who are known to be pregnant

2. Women who are breast feeding

3. Current or recent (last 3 months) participation in another clinical or intervention trial.

4. 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).

5. Substance abuse (within the last 1 years)

6. Completely sedentary individuals as assessed by the School of Sport and Exercise Sciences General Health Questionnaire

7. Consumption of alcohol 24 hours prior to Visit 2

8. Current or recent (within the last 30 days) smoker

9. Engaged in prolonged periods of food abstinence (e.g., for health or religious reasons) that may influence the normal metabolic response to exercise

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
No intervention


Locations

Country Name City State
United Kingdom University of Birmingham Birmingham West Midlands

Sponsors (3)

Lead Sponsor Collaborator
University of Birmingham Biotechnology and Biological Sciences Research Council, GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No