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Exercise Substrate Utilisation and Endurance Performance Following Short-term Manipulation of Dietary Fat Intake

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ClinicalTrials.gov Identifier: NCT02568592
Recruitment Status : Unknown
Verified May 2016 by University of Birmingham.
Recruitment status was:  Active, not recruiting
First Posted : October 6, 2015
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Birmingham

Tracking Information
First Submitted Date  ICMJE May 13, 2015
First Posted Date  ICMJE October 6, 2015
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
Rates of fat oxidation during exercise [ Time Frame: 90 minutes of sub-maximal exercise ]
Rates of fat oxidation to be measured via indirect calorimetry during 90 minutes of submaximal exercise
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
  • 5km running performance [ Time Frame: Immediately following measurement of Primary Outcome measure ]
    Time to complete 5km on a treadmill
  • Change in plasma glucose concentration [ Time Frame: 90 minutes sub-maximal exercise ]
    Area under the plasma concentration versus time curve (AUC) of glucose
  • Change in Free Fatty Acid concentration [ Time Frame: 90 minutes sub-maximal exercise ]
    Area under the plasma concentration versus time curve (AUC) of Free Fatty Acid
  • Change in plasma glycerol concentration [ Time Frame: 90 minutes sub-maximal exercise ]
    Area under the plasma concentration versus time curve (AUC) of glycerol
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Substrate Utilisation and Endurance Performance Following Short-term Manipulation of Dietary Fat Intake
Official Title  ICMJE Exercise Substrate Utilisation and Endurance Performance Following Short-term Manipulation of Dietary Fat Intake in Women
Brief 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.

Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Dietary Modification
Intervention  ICMJE
  • Dietary Supplement: High Fat
    High Fat - Carbohydrate (20%), Fat (65%), Protein (15%)
  • Dietary Supplement: Normal
    Normal - Carbohydrate (50%), Fat (35%) and Protein (15%)
  • Dietary Supplement: 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.
Study Arms  ICMJE
  • Experimental: High Fat
    High Fat - Carbohydrate (20%), Fat (65%), Protein (15%)
    Intervention: Dietary Supplement: High Fat
  • Experimental: Normal
    Normal - Carbohydrate (50%), Fat (35%) and Protein (15%)
    Intervention: Dietary Supplement: Normal
  • Experimental: Normal + Extra Fat
    Normal + Extra Fat - Carbohydrate (50%), Fat (65%), Protein (15%). Carbohydrate and protein intake identical in absolute amounts to NORM (Normal), with an additional 30% extra energy coming from fat.
    Intervention: Dietary Supplement: Normal + Extra Fat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 2, 2015)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI >17.0 < 25 kg/m2
  • Good General Health
  • Accustomed to vigorous physical activity
  • Run > 2 times per week
  • V̇O2max >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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02568592
Other Study ID Numbers  ICMJE ERN_15-0012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Birmingham
Study Sponsor  ICMJE University of Birmingham
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Gareth A Wallis, PhD University of Birmingham
PRS Account University of Birmingham
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP