NCT07503990

Brief Summary

The goal of this clinical trial is to understand how consuming a pre-exercise meal in different food intake sequences affects substrate utilisation and endurance exercise performance in healthy trained athletes. Specifically, the main questions it aims to answer are:

  • Does consuming the pre-exercise meal in different food intake sequences alter the whole-body utilisation of fat and CHO at rest and during prolonged exercise at moderate to heavy intensities?
  • Does consuming the pre-execise meal in different food intake sequences alter time-trial performance?
  • Does consuming the pre-exercise meal in different food intake sequences alter other metabolic and physiological responses before, during or after exercise (i.e., blood glucose, blood lactate, heart rate (HR), ratings of perceived exertion (RPE), appetite)? To address these questions, researchers will compare eating the dietary sources of rapidly absorbed CHO at the end (CHO-last meal pattern) or at the start (CHO-first meal pattern) of a standardised pre-exercise meal, in a randomised, counterbalanced, crossover design. Two hours after starting the pre-exercise meal, participants will perform a 60-min submaximal test on a cycling ergometer at two different intensities (30 min at 90% of the ventilatory threshold (VT) 1 and 30 min at 50% VT1-VT2), followed by a 10-km cycling time trial (TT). In the screening visit participants will:
  • Be screened for cardiometabolic conditions
  • Perform an 8-12-min graded exercise test to determine their maximal pulmonary oxygen uptake (VO2max) and non-invasive submaximal anchors of performance (VT 1 and VT 2)
  • Be familiarised to the experimental procedures In experimental visits participants will:
  • Follow guidelines pertaining to dietary intake, exercise and sleep in the previous 24 hours
  • Have a standardised test meal in either the CHO-last or CHO-first food intake sequence
  • Have 3 drops of capillary blood (0,9 µL in total) collected to measure glucose and lactate pre-meal, 15, 30, 45, 60, 90 and 120 min post-meal, every 15 min during submaximal exercise and post-TT
  • Breathe into an indirect calorimetry mask for 5 min pre-meal, 15, 30, 45, 60, 90 and 120 min post-meal, every 15 min during submaximal exercise and post-TT
  • Wear a HR monitor continuously during submaximal exercise and the TT
  • Rate their appetite on visual analogue scales pre-meal, 15, 30, 45, 60, 90 and 120 min post-meal, and 30 min post-TT
  • Rate their perceived exertion on RPE scales every 15 min during submaximal exercise, post-TT and 30 min post-TT. Data will be compared within-participant between food intake sequences using linear mixed-effects models with random intercepts, to account for repeated measurements, interindividual variability, and potential missing data.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress40%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

November 14, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

November 14, 2025

Last Update Submit

March 26, 2026

Conditions

Keywords

food ordermeal sequenceglucose metabolismsubstrate utilisationsport nutrition

Outcome Measures

Primary Outcomes (2)

  • Whole-body fat oxidation

    Difference between CHO-last and CHO-first meal patterns in the whole-body fat oxidation rate (g/min) over time adjusted for baseline, measured by indirect calorimetry.

    Every 15 minutes post-meal (0-120 minutes), every 15 minutes throughout the subsequent standardised exercise protocol (120-180 minutes)

  • Time-trial performance

    Difference between CHO-last and CHO-first meal patterns in the time to complete (min:sec) a 10-km cycling TT, assessed using a validated cycle ergometer.

    Immediately upon completion of the time trial subsequent to the post-meal resting period (0-120 minutes) and standardised exercise protocol (120-180 minutes)

Secondary Outcomes (9)

  • Time-trial power output

    Immediately upon completion of the time trial subsequent to the post-meal resting period (0-120 minutes) and standardised exercise protocol (120-180 minutes)

  • Whole-body CHO oxidation

    Every 15 minutes post-meal (0-120 minutes), every 15 minutes throughout the subsequent standardised exercise protocol (120-180 minutes)

  • Respiratory exchange ratio (RER)

    Every 15 minutes post-meal (0-120 minutes), every 15 minutes throughout the subsequent standardised exercise protocol (120-180 minutes)

  • Energy expenditure

    Every 15 minutes post-meal (0-120 minutes), every 15 minutes throughout the subsequent standardised exercise protocol (120-180 minutes)

  • Blood glucose concentrations

    Every 15 minutes post-meal in the first hour (0-60 min), every 30 minutes in the second hour (60-120 min), every 15 minutes throughout the standardised exercise protocol (120-180 min) and immediately upon completion of the subsequent time trial

  • +4 more secondary outcomes

Study Arms (2)

CL-CF

EXPERIMENTAL

The interventions (carbohydrate-last meal pattern (CL) or carbohydrate-first meal pattern (CF)) will be delivered in random order at two study visits, separated by a wash-out period of at least 7 days. If participants are allocated to this study arm, they will receive the CL on the first visit and the CF on the second visit. The nutritional composition of the test-meal will comply to the current sports nutrition guidelines for the pre-exercise meal (i.e., 1-4 g of CHO/kg of body mass, moderate amounts of protein, low-fat and fibre content, 5-10 mL/kg of body mass of fluids) (Thomas et al., 2016). Participants will be encouraged to consume the meal in full within 15 minutes, at a comfortable pace, to mimic real eating circumstances.

Other: Carbohydrate-last meal patternOther: Carbohydrate-first meal pattern

CF-CL

ACTIVE COMPARATOR

The interventions (carbohydrate-last meal pattern (CL) or carbohydrate-first meal pattern (CF)) will be delivered in random order at two study visits, separated by a wash-out period of at least 7 days. If participants are allocated to this study arm, they will receive the CF on the first visit and the CL on the second visit. The test-meal will be identical and isocaloric in both interventions of the study.

Other: Carbohydrate-last meal patternOther: Carbohydrate-first meal pattern

Interventions

Skyr yoghurt, whey protein and almonds over \~5 min, immediately followed by white bread, strawberry jam, banana and pulp-free orange juice over \~10 min.

Also known as: CHO-last, CL
CF-CLCL-CF

White bread, strawberry jam, banana and pulp-free orange juice over \~10 min, immediately followed by skyr yoghurt, whey protein and almonds over \~5 min.

Also known as: CHO-first, CF
CF-CLCL-CF

Eligibility Criteria

Age18 Years - 64 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCisgender
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult (18-64 years old)
  • Men
  • Endurance-trained athletes (meeting training and performance caliber criteria ≥Tier 2; McKay et al., 2022)

You may not qualify if:

  • Normal glucose tolerant according to the latest criteria established by the American Diabetes Association (2024): HbA1c \<5.7%, fasting plasma glucose \<5.6 mmol/L (100 mg/dL) or 2-h plasma glucose \<7.8 mmol/L (140 mg/dL) during a 75-g OGTT
  • Able and willing to provide informed consent and safely comply with study procedures
  • Any medical condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias into the experiment (e.g. cardiovascular disease; alcohol or substance abuse; any condition affecting the glucose or lipid metabolism, reviewed on a case by case basis)
  • Any reported medication or supplementation that may interfere with the glucose metabolism (e.g., acarbose, insulin, metformin, semaglutide, thiazolidinediones, sulfonylureas, corticosteroids, thiazide diuretics) or lipid metabolism (e.g., statins, nicotinic acid, colestyramine anhydrous, ezetimibe, fibrates, L-carnitine). Other medication and supplementation will be reviewed on a case by case basis.
  • Known food allergy, intolerance or hypersensitivity to any of the test meal ingredients
  • Recent change in body mass (± 2 kg in the last 2 months)
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cidade do Futebol

Lisbon, Oeiras, 1495-433, Portugal

Location

Study Officials

  • Rita Giro

    FCNAUP, University of Porto; Federação Portuguesa de Futebol

    PRINCIPAL INVESTIGATOR

Central Study Contacts

João Brito, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Although participants and the researcher delivering the test meal will be able to see the ingredients and the order in which they are consumed, outcome assessors of subjective (e.g. RPE, appetite) and performance data will be blinded to the intervention sequence. Furthermore, participants will be blinded to their performance results during both study sessions.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This study is designed as a randomised, counterbalanced, crossover, superiority trial with two groups. Block randomization will be performed by an external researcher with a 1:1 allocation ratio, and allocation concealment will be ensured through the use of sequentially numbered, opaque, sealed envelopes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

March 31, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Anonymised IPD will be made available upon reasonable request directed to the corresponding author.

Shared Documents
SAP, ICF
Time Frame
IPD will become accessible following the publication of all study findings.
Access Criteria
IPD will be made available to researchers with legitimate scientific purposes (such as systematic reviews or meta-analyses).

Locations