NCT07829237

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Jun 2027

First Submitted

Initial submission to the registry

September 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 14, 2026

Last Update Submit

September 14, 2026

Conditions

Keywords

exercise metabolismsubstrate oxidationexercisenutritionproteincarbohydrate

Outcome Measures

Primary Outcomes (4)

  • 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.

    During the 90-minute exercise bout

  • 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.

    During the 90-min exercise bout

  • 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.

    During the 90-min exercise bout

  • 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.

    During the 90-min exercise bout

Secondary Outcomes (1)

  • Time to task failure

    Immediately following the 90-min exercise bout

Study Arms (3)

Carbohydrate (CHO)

EXPERIMENTAL

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

Protein (PRO)

EXPERIMENTAL

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

Fasted (FAST)

PLACEBO COMPARATOR

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

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.

Carbohydrate (CHO)

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.

Protein (PRO)

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.

Fasted (FAST)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Body mass index (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

You may not qualify if:

  • Polycystic ovarian syndrome (PCOS) or endometriosis Current use of oral contraceptives 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 corticosteroids or non-steroidal anti-inflammatory drugs (NSAIDs) Currently following a low-carbohydrate diet, such as a ketogenic or Atkins diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre for High Performance Sport

Toronto, Ontario, M5S 2C9, Canada

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jenna Gillen, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Each participant will complete three pre-exercise nutrition conditions (carbohydrate, protein, and fasted/placebo) in a randomized, counterbalanced order, with a minimum 3-day washout period between conditions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 18, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

September 18, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations