ClinicalTrials.gg
RecruitingNCT07829237FLUXUpdated Sep 18, 2026

FueL Use During eXercise in Males and Females

An interventional study of Pre-exercise carbohydrate beverage and Pre-exercise protein beverage in Healthy Adults, sponsored by University of Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by University of Toronto · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

This study will investigate whether pre-exercise nutrition influences sex differences in fuel utilization during endurance exercise. Twenty-four recreationally active adults (12 females and 12 males) will complete three experimental exercise trials in a randomized, counterbalanced crossover design. Before each trial, participants will consume either a carbohydrate beverage, a protein-based beverage, or a flavour-matched non-caloric beverage representing the fasted condition. Thirty minutes later, participants will complete 90 minutes of moderate-intensity cycling followed by a cycling time-to-task-failure test. Whole-body carbohydrate and fat oxidation, exogenous substrate oxidation, blood metabolites, and exercise performance will be assessed.

Read the detailed description

Sex differences in substrate utilization during fasted endurance exercise are well established, with females generally demonstrating greater reliance on fat oxidation and lower carbohydrate utilization than males. However, exercise is frequently performed following nutrient ingestion, and it remains unclear whether sex differences in substrate utilization persist when carbohydrate or protein is consumed before exercise.

This randomized, counterbalanced crossover study will compare three pre-exercise nutritional conditions: carbohydrate (CHO), protein (PRO), and fasted/placebo (FAST). Participants will complete each condition separated by a minimum three-day washout. Following an overnight fast, participants will consume the assigned beverage and rest for 30 minutes before completing 90 minutes of cycling at 65% of VO2peak. This will be followed by a two-minute rest and a cycling time-to-task-failure test at 85% of maximal work rate.

The primary objective is to determine whether pre-exercise nutrition modifies sex differences in whole-body carbohydrate and fat oxidation and exogenous substrate oxidation during exercise. A secondary objective is to determine the effects of pre-exercise nutrition and sex on subsequent exercise performance.

02

Conditions studied

  • Healthy Adults

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Keywords

  • exercise metabolism
  • substrate oxidation
  • exercise
  • nutrition
  • protein
  • carbohydrate
03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's planned enrollment of 24 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

University of Toronto is the lead sponsor of 403 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participating in ≥150 minutes of moderate-to-vigorous physical activity per week
  • VO₂peak classified as "good" or above based on American College of Sports Medicine normative values: >35.0 mL/kg/min for females and >39.0 mL/kg/min for males
  • (BMI) between 18 and 27 kg/m²
  • Participating in 3-5 structured exercise sessions per week
  • Weight stable, defined as within ±2 kg for at least 6 months
  • Non-smoker
  • Females must be eumenorrheic

Exclusion criteria

Exclusion Criteria:

  • Polycystic ovarian syndrome (PCOS) or endometriosis Current use of oral or oral contraceptive use within the previous 3 months Diagnosed cardiovascular or metabolic disease Hypergonadism or hypogonadism Use of medications for management of blood glucose or lipid metabolism Pregnant or \<12 months postpartum Lactating or breastfeeding within 3 months of study commencement Menopausal Recreational tobacco smoking Inability to complete the study exercise protocols or comply with pre-trial dietary or physical activity controls Use of medications that may affect substrate metabolism, including or non-steroidal anti-inflammatory drugs (NSAIDs) Currently following a low-carbohydrate diet, such as a ketogenic or Atkins diet
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Carbohydrate (CHO)

    Participants will consume a carbohydrate beverage following an overnight fast. Thirty minutes after beverage consumption, participants will complete 90 minutes of cycling at 65% of VO2peak, followed by a 2-minute rest and a cycling time-to-task-failure test at 85% of maximal work rate.

    Dietary Supplement: Pre-exercise carbohydrate beverage

  • Experimental
    Protein (PRO)

    Participants will consume a protein-based beverage following an overnight fast. Thirty minutes after beverage consumption, participants will complete 90 minutes of cycling at 65% of VO2peak, followed by a 2-minute rest and a cycling time-to-task-failure test at 85% of maximal work rate.

    Dietary Supplement: Pre-exercise protein beverage

  • Placebo comparator
    Fasted (FAST)

    Participants will remain fasted and consume a non-caloric, flavour-matched beverage. Thirty minutes after beverage consumption, participants will complete 90 minutes of cycling at 65% of VO2peak, followed by a 2-minute rest and a cycling time-to-task-failure test at 85% of maximal work rate.

    Other: Fasted control beverage

Interventions

  • Dietary supplementPre-exercise carbohydrate beverage

    A carbohydrate beverage providing 1 g glucose/kg body mass, enriched with 1 mg/kg body mass \[U-13C6\]-D-glucose for assessment of exogenous carbohydrate oxidation, with calorie-free flavouring. The beverage will be consumed within 5 minutes, 30 minutes before exercise.

  • Dietary supplementPre-exercise protein beverage

    A protein-based beverage providing 0.45 g protein/kg body mass and supplemented with 0.24 g fat/kg body mass to match the energy content of the carbohydrate condition. The beverage is enriched with L-\[1-13C\]leucine and flavour-matched to the carbohydrate beverage. It will be consumed within 5 minutes, 30 minutes before exercise.

  • OtherFasted control beverage

    A non-caloric beverage consisting of water and sugar-free flavouring, flavour-matched to the carbohydrate beverage. The beverage will be consumed within 5 minutes following an overnight fast, 30 minutes before exercise.

06

What researchers measure

Primary outcomes

  1. Whole-body carbohydrate oxidation

    Whole-body carbohydrate oxidation will be calculated from oxygen consumption (VO2) and carbon dioxide production (VCO2) measured by indirect calorimetry during 90 minutes of moderate-intensity cycling. Carbohydrate oxidation will be compared between the carbohydrate, protein, and fasted conditions and between females and males.

    Time frame: During the 90-minute exercise bout

  2. Whole-body fat oxidation

    Whole-body fat oxidation will be calculated from VO2 and VCO2 measured by indirect calorimetry during 90 minutes of moderate-intensity cycling. Fat oxidation will be compared between the carbohydrate, protein, and fasted conditions and between females and males.

    Time frame: During the 90-min exercise bout

  3. Exogenous glucose oxidation

    Exogenous glucose oxidation will be determined during the carbohydrate condition using breath 13CO2 enrichment following ingestion of \[U-13C6\]-D-glucose. Breath samples will be analyzed by isotope ratio mass spectrometry, and exogenous glucose oxidation will be calculated using 13CO2 enrichment and carbon dioxide production.

    Time frame: During the 90-min exercise bout

  4. Exogenous leucine oxidation

    Exogenous leucine oxidation will be determined during the protein condition using breath ¹³CO₂ enrichment following ingestion of L-\[1-¹³C\]leucine. Breath samples will be analyzed by isotope ratio mass spectrometry, and exogenous leucine oxidation will be calculated using breath ¹³CO₂ enrichment and carbon dioxide production.

    Time frame: During the 90-min exercise bout

Secondary outcomes

  1. Time to task failure

    Exercise performance will be assessed as time to volitional exhaustion during a cycling time-to-task-failure test performed at 85% of maximal work rate following the 90-minute moderate-intensity cycling bout.

    Time frame: Immediately following the 90-min exercise bout

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 9 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2026
First posted
Sep 18, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07829237
Responsible party
Jenna Gillen (Associate Professor, University of Toronto) — Principal investigator
First posted
Sep 18, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

Jenna Gillen, PhD
Contact
jenna.gillen@utoronto.ca
4169783244
Victoria Bennett
Contact
victoria.bennett@mail.utoronto.ca
4169783244
Jenna Gillen, PhD
principal investigator · University of Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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