NCT06365385

Brief Summary

Emerging evidence suggests that following a 'carbohydrate-last meal pattern', wherein foods rich in protein, fat, fiber, and/or polyphenols are consumed before sources of simple carbohydrate (CHO) in a meal, results in reduced postprandial glycaemic responses than the reverse food order or a co-ingestion pattern. This effect has been observed across the spectrum of glucose tolerance, from patients with diabetes to individuals with normal glucose tolerance (Kuwata et al., 2016; Nishino et al., 2018; Lu et al., 2019; Sun et al., 2020). Furthermore, reduced glucose excursions have been linked to decreased subsequent hunger and energy intake (Lu et al., 2019; Wyatt et al., 2021). However, to date, no studies on food intake sequence have targeted athletes, despite their increased CHO demands (Thomas et al., 2016) which could expose them to repeated episodes of hyperglycaemia and high glycaemic variability, known to increase the risk of adverse cardiovascular outcomes and all-cause mortality (Loader et al., 2015; Cavero-Redondo et al., 2017; Faerch et al., 2018). Additionally, athletes often face pressure to meet body composition standards and may benefit from strategies that enhance satiety and craving control. Finally, there is reason to believe that better glycaemic control could lead to improved performance, given that enhancements in endurance activities have been observed with a low-glycemic-index diet compared to a high-glycemic-index diet (Heung-Sang Wong et al., 2017). Therefore, this randomised crossover trial is part of a wider project which seeks to explore the impact of food intake sequence on metabolic health and performance in athletes. Specifically, this trial aims to investigate the acute, postprandial metabolic and appetite responses to consuming an identical meal in two intake sequences (CHO-last versus CHO-first) in athletes, while in the resting state.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2024

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

April 9, 2024

Last Update Submit

December 18, 2024

Conditions

Keywords

food ordermeal sequenceglucose metabolismlipid metabolismsatietysport nutrition

Outcome Measures

Primary Outcomes (1)

  • Postprandial blood glucose concentrations

    Difference between food intake sequences in the incremental area under the curve 0-120 and 0-180 min; peak concentrations (mmol/L); time-to-peak (min); and change from baseline data (mmol/L) of capillary blood glucose measured by a validated glucometer

    Baseline and 15, 30, 45, 60, 90, 120, 180 minutes following the test meal

Secondary Outcomes (10)

  • Postprandial subjective appetite ratings

    Baseline and 15, 30, 45, 60, 90, 120, 180 minutes following the test meal

  • Prospective ad libitum energy intake

    0-3 hours post-trial

  • Prospective ad libitum nutritional intake

    0-3 hours post-trial

  • Postprandial serum insulin concentrations

    Baseline and 30, 60, 90, 120, 180 minutes following the test meal

  • Postprandial plasma total GLP-1 concentrations

    Baseline and 30, 60, 90, 120, 180 minutes following the test meal

  • +5 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 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 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: CL; CHO-last
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: CF; CHO-first
CF - CLCL - CF

Eligibility Criteria

Age18 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult (18-64 years old)
  • Male
  • Trained (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 (ElSayed et al., 2023): HbA1c \<5.7%, fasting plasma glucose \<5.6 mmol/L (100 mg/dL) and 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. anaemia and other haematological disorders; alcohol or substance abuse; any condition affecting the glucose and lipid metabolism or appetite, 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); lipid metabolism (e.g., statins, nicotinic acid, colestyramine anhydrous, ezetimibe, fibrates, L-carnitine); or appetite (e.g., metoclopramide, carbamazepine, phenobarbital, phenytoin, primidone). 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
  • Having donated more than 400 ml of blood within 3 months of the screening visit or more than 1500ml of blood in the previous 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cidade do Futebol, Avenida das Seleções

Oeiras, Lisbon District, 1495-433, Portugal

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Rita Giro

    FCNAUP, University of Porto; Portugal Football School, Federação Portuguesa de Futebol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This is a non-blind trial, since both participants and the investigator delivering the test-meal will be able to see the ingredients and the order in which they are consumed. However, outcome assessors will be blinded to the intervention sequence.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This study is a randomised controlled trial with a counterbalanced crossover design. Block randomisation will be performed by an external researcher, 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

April 9, 2024

First Posted

April 15, 2024

Study Start

April 22, 2024

Primary Completion

December 16, 2024

Study Completion

December 16, 2024

Last Updated

December 24, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations