NCT02568592

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

May 13, 2015

Last Update Submit

May 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 5km running performance

    Immediately following measurement of Primary Outcome measure

  • Change in plasma glucose concentration

    90 minutes sub-maximal exercise

  • Change in Free Fatty Acid concentration

    90 minutes sub-maximal exercise

  • Change in plasma glycerol concentration

    90 minutes sub-maximal exercise

Study Arms (3)

High Fat

EXPERIMENTAL

High Fat - Carbohydrate (20%), Fat (65%), Protein (15%)

Dietary Supplement: High Fat

Normal

EXPERIMENTAL

Normal - Carbohydrate (50%), Fat (35%) and Protein (15%)

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.

Dietary Supplement: Normal + Extra Fat

Interventions

High FatDIETARY_SUPPLEMENT

High Fat - Carbohydrate (20%), Fat (65%), Protein (15%)

High Fat
NormalDIETARY_SUPPLEMENT

Normal - Carbohydrate (50%), Fat (35%) and Protein (15%)

Normal
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.

Normal + Extra Fat

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

MeSH Terms

Interventions

Diet, High-Fat

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Gareth A Wallis, PhD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

October 6, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations