Dietary ModificationNCT02568592
Exercise Substrate Utilisation and Endurance Performance Following Short-term Manipulation of Dietary Fat Intake
A study testing High Fat, Normal and Normal + Extra Fat in people with Dietary Modification, run by University of Birmingham at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- High Fat, Normal and Normal + Extra Fat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham
Birmingham, West Midlands, B15 2TT
About this study
Official title: 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.
Read the 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.
- Conditions
- Dietary Modification
- Being tested
- High Fat, Normal, Normal + Extra Fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High FatDietary supplement
High Fat - Carbohydrate (20%), Fat (65%), Protein (15%)
NormalDietary supplement
Normal - Carbohydrate (50%), Fat (35%) and Protein (15%)
Normal + Extra FatDietary supplement
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 group | Role | What they receive |
|---|---|---|
| High Fat | Experimental | High Fat - Carbohydrate (20%), Fat (65%), Protein (15%) Receives: Dietary Supplement: High Fat |
| Normal | Experimental | Normal - Carbohydrate (50%), Fat (35%) and Protein (15%) Receives: Dietary Supplement: Normal |
| Normal + Extra Fat | Experimental | 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. Receives: Dietary Supplement: Normal + Extra Fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of fat oxidation during exercise
Rates of fat oxidation to be measured via indirect calorimetry during 90 minutes of submaximal exercise
Measured: 90 minutes of sub-maximal exercise
Secondary outcomes (4)
5km running performance
Time to complete 5km on a treadmill
Measured: Immediately following measurement of Primary Outcome measure
Change in plasma glucose concentration
Area under the plasma concentration versus time curve (AUC) of glucose
Measured: 90 minutes sub-maximal exercise
Change in Free Fatty Acid concentration
Area under the plasma concentration versus time curve (AUC) of Free Fatty Acid
Measured: 90 minutes sub-maximal exercise
Change in plasma glycerol concentration
Area under the plasma concentration versus time curve (AUC) of glycerol
Measured: 90 minutes sub-maximal exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Gareth A Wallis, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568592
- Sponsor's protocol ID
- ERN_15-0012
- Status last verified
- May 2016
- First submitted
- 13 May 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Substrate Utilisation and Endurance Performance Following Short-term Manipulation of Dietary Fat Intake in Women
- ClinicalTrials.gov ID
- NCT02568592
- Acronym / sponsor ID
- ERN_15-0012
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Fat | Experimental | Dietary Supplement: High FatHigh Fat - Carbohydrate (20%), Fat (65%), Protein (15%) |
| Normal | Experimental | Dietary Supplement: NormalNormal - Carbohydrate (50%), Fat (35%) and Protein (15%) |
| Normal + Extra Fat | Experimental | Dietary Supplement: Normal + Extra FatNormal + 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- BMI >17.0 < 25 kg/m2
- Good General Health
- Accustomed to vigorous physical activity
- Run > 2 times per week
- V̇O2max >50ml/kg/min
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High FatHigh Fat - Carbohydrate (20%), Fat (65%), Protein (15%) | Dietary supplement | High Fat |
| NormalNormal - Carbohydrate (50%), Fat (35%) and Protein (15%) | Dietary supplement | Normal |
| Normal + Extra FatNormal + 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. | Dietary supplement | Normal + Extra Fat |
Primary outcome
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
4 secondary outcomes
5km running performance
Time frame: Immediately following measurement of Primary Outcome measure
Change in plasma glucose concentration
Time frame: 90 minutes sub-maximal exercise
Change in Free Fatty Acid concentration
Time frame: 90 minutes sub-maximal exercise
Change in plasma glycerol concentration
Time frame: 90 minutes sub-maximal exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gareth A Wallis, PhD principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Fat, Normal and Normal + Extra Fat in people with Dietary Modification, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of fat oxidation during exercise (time frame: 90 minutes of sub-maximal exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.