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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02568592
Other study ID # ERN_15-0012
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 13, 2015
Last updated May 11, 2016
Start date March 2015
Est. completion date June 2016

Study information

Verified date May 2016
Source University of Birmingham
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The capacity to burn fat as fuel for exercise may have important implications for sporting performance, with dietary fat intake positively influencing this ability.

Endurance performance and the ability to burn fat will be measured in women runners following the consumption of 3 diets varying in the amount of fat and carbohydrate.


Description:

Dietary fat intake positively influences the ability to burn fat during exercise in women but not men, whereas carbohydrate intake negatively influences fat oxidation in both sexes. The independent nature of dietary fat intake as a predictor of the ability to burn fat in women suggests that in conditions of adequate carbohydrate intake providing additional fat may increase fat oxidation in women whereas it does not in men. It is of interest to explore if indeed women are responsive (i.e., increase in fat oxidation) to short-term increases in dietary fat intake induced by overfeeding (adequate carbohydrate) or if as appears to be the case in men reduced carbohydrate intake as typically employed in high-fat, low carbohydrate dietary studies is also a prerequisite for enhancing fat oxidation in women, and whether this translates into a difference in exercise endurance performance.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 16
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- BMI >17.0 < 25 kg/m2

- Good General Health

- Accustomed to vigorous physical activity

- Run > 2 times per week

- V?O2max >50ml/kg/min

- Weight Stable > last 6months

- Non Smoker

- Pre-menopausal, and either eumenorrheic and regularly menstruating, or using monophasic hormonal oral contraceptives for > 3 months.

Exclusion Criteria:

- Currently taking part in another scientific/clinical study

- Taking any prescription drug / supplement thought to influence metabolism

- Following unusual dietary practices (such as intermittent fasting or low carbohydrate diets)

- Pregnant

- Breast Feeding

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
High Fat
High Fat - Carbohydrate (20%), Fat (65%), Protein (15%)
Normal
Normal - Carbohydrate (50%), Fat (35%) and Protein (15%)
Normal + Extra Fat
Normal + Extra Fat - Carbohydrate (50%), Fat (65%), Protein (15%). Carbohydrate and protein intake identical in absolute amounts to NORMAL, with an additional 30% extra energy coming from fat.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Birmingham GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rates of fat oxidation during exercise Rates of fat oxidation to be measured via indirect calorimetry during 90 minutes of submaximal exercise 90 minutes of sub-maximal exercise No
Secondary 5km running performance Time to complete 5km on a treadmill Immediately following measurement of Primary Outcome measure No
Secondary Change in plasma glucose concentration Area under the plasma concentration versus time curve (AUC) of glucose 90 minutes sub-maximal exercise No
Secondary Change in Free Fatty Acid concentration Area under the plasma concentration versus time curve (AUC) of Free Fatty Acid 90 minutes sub-maximal exercise No
Secondary Change in plasma glycerol concentration Area under the plasma concentration versus time curve (AUC) of glycerol 90 minutes sub-maximal exercise No
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