Healthy Clinical Trial
Official title:
Postprandial Metabolic and Appetite Responses to Different Food Intake Sequences in Athletes
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | October 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Portugal | Cidade do Futebol, Avenida das Seleções | Oeiras | Lisboa |
Lead Sponsor | Collaborator |
---|---|
Universidade do Porto | Federação Portuguesa de Futebol, Fundação para a Ciência e a Tecnologia |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | Baseline and 15, 30, 45, 60, 90, 120, 180 minutes following the test meal | |
Secondary | 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 | 0-3 hours post-trial | |
Secondary | 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 | 0-3 hours post-trial | |
Secondary | 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 | Baseline and 30, 60, 90, 120, 180 minutes following the test meal | |
Secondary | 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 | Baseline and 30, 60, 90, 120, 180 minutes following the test meal | |
Secondary | 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 | Baseline and 30, 60, 90, 120, 180 minutes following the test meal | |
Secondary | 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 | Baseline and 30, 60, 90, 120, 180 minutes following the test meal | |
Secondary | 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 | Baseline and 30, 60, 90, 120, 180 minutes following the test meal | |
Secondary | 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 | Baseline and 30, 60, 90, 120, 180 minutes following the test meal | |
Secondary | 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 | Baseline and 30, 60, 90, 120, 180 minutes following the test meal |
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