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HealthyNCT06365385

Postprandial Metabolic and Appetite Responses to Different Food Intake Sequences in Athletes

A study testing Carbohydrate-last meal pattern and Carbohydrate-first meal pattern in people with Healthy and Nutrition, Healthy, run by Universidade do Porto at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years, men onlyHealthy volunteers can take part
What is being tested?
Carbohydrate-last meal pattern and Carbohydrate-first meal pattern
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 sitePortugal
Study dates
22 Apr 2024to 16 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adult (18-64 years old)
  • Male
  • Trained (meeting training and performance caliber criteria ≥Tier 2; McKay et al., 2022)
  • Healthy (meeting the exclusion criteria for medical conditions)
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • Cidade do Futebol, Avenida das Seleções

    Oeiras, Lisbon District, 1495-433

Other trials in Portugal

About this study

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.

Read the detailed description

Participants will be required to visit the research facilities at Cidade do Futebol (Portugal Football School's headquarters) on three separate occasions, following a 10-12-hour overnight fast and abstaining from alcohol consumption and strenuous physical activity the day before (e.g. no exercise causing sweating or heavy breathing). Visits will be separated by a wash-out period of 7 days to ensure participants experience similar dietary and physical activity patterns in the 24 hours preceding the trials. Each visit is expected to last approximately 4 hours.

In the screening and familiarisation visit, athletes will be asked to provide written informed consent to participate in the study and answer a series of questions to confirm their eligibility and safety for enrolment. Subsequently, an anthropometric assessment, blood pressure measurement, fasted blood collection and 2-hour 75-g oral glucose tolerance test (OGTT) will be performed to establish participants' baseline characteristics and analyse biochemical markers of the glucose and lipid metabolism to identify any further exclusion criteria (i.e., glycated haemoglobin (HbA1c); glucose; insulin; triglycerides; total, high-density lipoprotein and low-density lipoprotein cholesterol; haemogram and high-sensitivity C-reactive protein). To familiarise participants with the cannulation procedure ahead of the experimental trials, a trained and experienced nurse will insert a cannula (a small plastic tube) into a vein on the participants' arm, from which fasting and 2-h OGTT blood samples will be drawn (15 ml in total).

Eligible participants will be instructed to monitor their diet and physical activity for 24 hours before their first experimental visit and replicate these patterns before the second experimental visit.

In both experimental visits, participants will arrive at the research facilities between 8:00-9:00 and rest comfortably for 10 minutes. Body mass and blood pressure will be remeasured. Then, cannulation will be performed, and 18.5 ml venous blood samples will be drawn immediately before and at 30, 60, 90, 120, and 180 minutes after the meal challenge to assess postprandial changes in insulin, glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), ghrelin, peptide YY (PYY), triglycerides, and non-esterified fatty acids (NEFA) concentrations. At similar timepoints, as well as at 15 and 45 minutes, capillary blood glucose will be measured using a finger prick glucometer, and appetite ratings will be marked by the athletes on 100-mm visual analogue scales.

Upon completing the research assessments, participants will be asked to photograph and record the timing, type, and amounts of foods, drinks, and/or supplements consumed for an additional 3 hours to evaluate their prospective, ad libitum intake.

Being tested
Carbohydrate-last meal pattern, Carbohydrate-first meal pattern
Keywords
food order, meal sequence, glucose metabolism, lipid metabolism, satiety, sport nutrition
Medical subject headings
Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carbohydrate-last meal patternOther

    Also called CL; CHO-last

    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.

  • Carbohydrate-first meal patternOther

    Also called CF; CHO-first

    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.

Study groups in NCT06365385
Study groupRoleWhat they receive
CL - CFExperimentalThe 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.
Receives: Other: Carbohydrate-last meal pattern; Other: Carbohydrate-first meal pattern
CF - CLActive comparatorThe 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.
Receives: Other: Carbohydrate-last meal pattern; Other: Carbohydrate-first meal pattern

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (10)
  1. Postprandial subjective appetite ratings

    Difference between food intake sequences in the total area under the curve 0-180 min; peak/nadir rating (mm); time-to-peak/nadir (min); and change from baseline data (mm) of appetite ratings measured by validated 100-mm visual analogue scales (Flint et al, 2000)

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

  2. Prospective ad libitum energy intake

    Difference between food intake sequences in the total energy (kcal) consumed within 3 hours from the end of the experimental visit, assessed by a photography-supported dietary record of foods and fluids

    Measured: 0-3 hours post-trial

  3. Prospective ad libitum nutritional intake

    Difference between food intake sequences in the total carbohydrate, protein and fat (grams; g/kg of body mass and % of total energy intake) consumed within 3 hours from the end of the experimental visit, assessed by a photography-supported dietary record of foods and fluids

    Measured: 0-3 hours post-trial

  4. Postprandial serum insulin concentrations

    Difference between food intake sequences in the incremental area under the curve 0-120 and 0-180 min; peak concentrations (microIU/ml); time-to-peak (min); and change from baseline data (microIU/ml) of serum insulin measured by a chemiluminescent immunoassay

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

  5. Postprandial plasma total GLP-1 concentrations

    Difference between food intake sequences in the incremental area under the curve 0-120 and 0-180 min; peak concentrations (pg/ml); time-to-peak (min); and change from baseline data (pg/ml) of plasma GLP-1 measured by a total GLP-1 ELISA kit

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

  6. Postprandial plasma total GIP concentrations

    Difference between food intake sequences in the incremental area under the curve 0-120 and 0-180 min; peak concentrations (pg/ml); time-to-peak (min); and change from baseline data (pg/ml) of plasma GIP measured by a total GIP ELISA kit

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

  7. Postprandial serum total ghrelin concentrations

    Difference between food intake sequences in the total area under the curve 0-120 and 0-180 min; nadir concentrations (pg/ml); time-to-nadir (min); and change from baseline data (pg/ml) of serum ghrelin measured by a total ghrelin ELISA kit

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

  8. Postprandial plasma total PYY concentrations

    Difference between food intake sequences in the incremental area under the curve 0-120 and 0-180 min; peak concentrations (pg/ml); time-to-peak (min); and change from baseline data (pg/ml) of plasma PYY measured by a total PYY ELISA kit

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

  9. Postprandial serum triglyceride concentrations

    Difference between food intake sequences in the incremental area under the curve 0-180 min; peak concentrations (mmol/L); time-to-peak (min); and change from baseline data (mmol/L) of serum triglycerides measured by the GPO/POD method

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

  10. Postprandial serum NEFA concentrations

    Difference between food intake sequences in the total area under the curve 0-180 min; nadir concentrations (mmol/L); time-to-nadir (min); and change from baseline data (mmol/L) of serum NEFA measured by an enzymatic colorimetric assay

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2024
  2. Study start22 Apr 2024
  3. Primary completion16 Dec 2024
  4. Study completion16 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06365385
Sponsor's protocol ID
FOODSEQ-MARS
Status last verified
Dec 2024
First submitted
9 Apr 2024
Last updated
24 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Giro R, Monteiro CP, Oliveira CB, Rebelo P, Goncalves J, Fernandes TM, Borges N, Teixeira VH, Brito J. Food intake sequence affects postprandial metabolic, hormonal, and appetite responses in healthy male football players: a randomised crossover trial. Clin Nutr ESPEN. 2026 Aug 19:105037. doi: 10.1016/j.clnesp.2026.105037. Online ahead of print.

    PubMed 42617805

Questions about this trial

What is this clinical trial studying?

A study testing Carbohydrate-last meal pattern and Carbohydrate-first meal pattern in people with Healthy and Nutrition, Healthy, run by Universidade do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial blood glucose concentrations (time frame: Baseline and 15, 30, 45, 60, 90, 120, 180 minutes following the test meal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06365385, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.

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