- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02568592
Exercise Substrate Utilisation and Endurance Performance Following Short-term Manipulation of Dietary Fat Intake
May 11, 2016 updated by: University of Birmingham
Exercise Substrate Utilisation and Endurance Performance Following Short-term Manipulation of Dietary Fat Intake in Women
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
West Midlands
-
Birmingham, West Midlands, United Kingdom, B15 2TT
- University of Birmingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Fat
High Fat - Carbohydrate (20%), Fat (65%), Protein (15%)
|
High Fat - Carbohydrate (20%), Fat (65%), Protein (15%)
|
|
Experimental: Normal
Normal - Carbohydrate (50%), Fat (35%) and Protein (15%)
|
Normal - Carbohydrate (50%), Fat (35%) and Protein (15%)
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
90 minutes of sub-maximal exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
5km running performance
Time Frame: Immediately following measurement of Primary Outcome measure
|
Time to complete 5km on a treadmill
|
Immediately following measurement of Primary Outcome measure
|
|
Change in plasma glucose concentration
Time Frame: 90 minutes sub-maximal exercise
|
Area under the plasma concentration versus time curve (AUC) of glucose
|
90 minutes sub-maximal exercise
|
|
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
|
90 minutes sub-maximal exercise
|
|
Change in plasma glycerol concentration
Time Frame: 90 minutes sub-maximal exercise
|
Area under the plasma concentration versus time curve (AUC) of glycerol
|
90 minutes sub-maximal exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gareth A Wallis, PhD, University of Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
June 1, 2016
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
May 13, 2015
First Submitted That Met QC Criteria
October 2, 2015
First Posted (Estimate)
October 6, 2015
Study Record Updates
Last Update Posted (Estimate)
May 13, 2016
Last Update Submitted That Met QC Criteria
May 11, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- ERN_15-0012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dietary Modification
-
Brown UniversityNational Cancer Institute (NCI); University of ConnecticutCompletedDietary Habits | Dietary Modification
-
University of ReadingUnknownDietary Habits | Dietary ModificationUnited Kingdom
-
University of ReadingCompletedDietary Habits | Dietary ModificationUnited Kingdom
-
University of ParmaCompletedDietary ModificationItaly
-
University of ParmaCompleted
-
University of ParmaCompletedDietary ModificationItaly
-
University of British ColumbiaCompleted
-
McMaster UniversityCompleted
-
University of GreenwichCompleted
-
University of ParmaCompletedDietary ModificationItaly
Clinical Trials on High Fat
-
Wageningen UniversityDutch Diabetes Research FoundationCompletedObesity | Cardiovascular Disease | Diabetes Type 2Netherlands
-
USDA, Western Human Nutrition Research CenterTerminatedObesity | Overweight | Body WeightUnited States
-
Agroscope Liebefeld-Posieux Research Station ALPCompletedObesity | Nutritional InterventionSwitzerland
-
University of Alabama at BirminghamSmartFoods, Inc.Completed
-
National Institute of Diabetes and Digestive and...Not yet recruitingDiabetes | Metabolic Syndrome | Healthy Volunteer | Nephrotic Syndrome | Lipodystrophy | Metabolic Associated Steatotic Liver DiseaseUnited States
-
Maastricht University Medical CenterCompleted
-
Hvidovre University HospitalUniversity of Copenhagen; Danish Research Centre for Magnetic ResonanceCompletedDiabetes | Metabolic Syndrome | NAFLD | Overweight and ObesityDenmark
-
University of ArkansasCompletedDiabetes Mellitus | HypertriglyceridemiaUnited States
-
UCSF Benioff Children's Hospital OaklandNational Cattlemen's Beef AssociationCompletedHealthy | Cardiovascular Disease | Atherogenic DyslipidemiaUnited States
-
Haukeland University HospitalUniversity of BergenCompleted