- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07936006
Effects of Hypoxia or Caffeine on 4km Time-trial Morning Cycling.
This study aims to implement a rigorously standardized protocol to investigate the effect of acute (60 min prior) caffeine intake or hypoxia (1000m and 2000m) on 4km time trial performance.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Time-trial performance is widely regarded as the gold-standard measure of endurance exercise capacity, because successful performance depends on completing a fixed distance in the shortest possible time while effectively regulating pacing strategy and power output. As a result, time-trial performance is considered as one of the most ecologically valid measures of endurance performance in both laboratory investigations and applied sport settings. For many endurance athletes, training and competition frequently occur during the morning due to event scheduling, travel requirements and environmental considerations. However, the morning period is characterised by several time-of-day-related physiological differences that may negatively influence exercise performance. Although systematic reviews have reported substantial variability in the magnitude of diurnal fluctuations in time-trial performance, evidence from well-controlled laboratory studies using fixed-distance protocols under thermoneutral conditions consistently indicates superior performance during the late afternoon or evening. Specifically, improvements in evening performance have been observed across a range of endurance modalities, including 100-m swimming (2.6%), 1-km cycling (2.3%), 4-km cycling (2.6%), 10-km cycling (2.3%), 10-km treadmill running (6.3%), and 16.1-km cycling (3.6%). These findings suggest that morning time-trial performance may be compromised relative to later times-of-day, potentially due to circadian variations in physiological and psychological readiness for exercise. Given that athletes are often required to compete in the morning despite these potential limitations, identifying practical and effective strategies to enhance morning time-trial performance is of considerable interest to athletes, coaches and practitioners seeking to optimise competitive outcomes.
Among the nutritional strategies proposed to improve morning performance, acute caffeine ingestion remains one of the most widely consumed and extensively studied ergogenic aids. Caffeine (1,3,7-trimethylxanthine) primarily exerts its performance-enhancing effects through antagonism of adenosine receptors in the central nervous system, resulting in increased arousal, reduced perceptions of fatigue, and enhanced neurotransmitter activity, including dopamine and noradrenaline. These neurophysiological effects collectively promote wakefulness, attention and central motor drive, thereby facilitating exercise performance. Consistent with these mechanisms, substantial evidence demonstrates that caffeine can improve endurance exercise capacity and time-trial performance across a variety of exercise modalities. Despite the well-established ergogenic effects of caffeine, research examining its efficacy during morning time-trial exercise remains comparatively limited. Interpretation of the available literature is further complicated by several methodological shortcomings, including inconsistent caffeine dosing protocols, inadequate familiarisation procedures and poor control of habitual caffeine intake. Recognising the importance of habitual caffeine consumption as a moderator of physiological and performance responses, recent classification thresholds have been proposed. Categorising individuals as naïve (<25 mg·day-¹), low (25 mg·day-¹ to 0.99 mg·kg-¹·day-¹), mild (1.00-2.99 mg·kg-¹·day-¹), moderate (3.00-5.99 mg·kg-¹·day-¹), high (6.00-8.99 mg·kg-¹·day-¹), and very high (>9.00 mg·kg-¹·day-¹) caffeine consumers. Failure to adequately characterise and control habitual caffeine intake may therefore contribute to the variability observed across studies.
Additional methodological limitations within the existing literature include the absence of both placebo and no-pill comparator conditions, together with insufficient control of key chronobiological variables such as chronotype, sleep quality, habitual training time, and seasonal influences. These factors are particularly relevant given their established influence on exercise performance and their potential to confound assessments of both circadian variation and caffeine-related ergogenic effects. Indeed, recent systematic reviews have identified substantial methodological heterogeneity and risk of bias across chronobiology studies, highlighting the need for more rigorous and standardised experimental designs when investigating time-of-day effects on exercise performance. Consequently, well-controlled studies are required to determine whether acute caffeine ingestion can meaningfully attenuate the physiological disadvantages associated with morning endurance exercise and improve time-trial performance under ecologically valid conditions.
Therefore, the primary aim of the present study was to determine whether the ergogenic effects of acute caffeine (CAFF) ingestion, administered 60-min before exercise, enhance morning 4-km cycling time-trial performance when evaluated when behavioural, methodological and chronobiological confounders were carefully controlled. Habitual caffeine consumers with an intake of >150 mg·day-¹ were recruited to minimise the potential influence of caffeine tolerance and withdrawal, while maximising the physiological response to the administered 300 mg caffeine dose. Secondary outcomes included measures of core and skin temperature, ratings of perceived exertion (RPE), mood-state and physiological responses to exercise.
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ben J Edwards, PhD
- Numéro de téléphone: 01519046238
- E-mail: B.J.Edwards@ljmu.ac.uk
Lieux d'étude
-
-
Merseyside
-
Liverpool, Merseyside, Royaume-Uni, L3 3AF
- Recrutement
- Tom Reilly Building
-
Contact:
- Joao Agulhari, BSc
- Numéro de téléphone: 07379664724
- E-mail: jpagulhari@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age: 18-30 years old
- Healthy (as determined by the pre-participation questionnaire)
- >2 years aerobically trained individuals
- Consume >150 mg/day of caffeine
- Be able to stick to the retiring and waking schedule of the study as well as no exercise 24 h before and no caffeine.
Exclusion Criteria:
- Age: <18 or >30 years old
- Consume <150 mg/day of caffeine hence caffeine naïve
- Those with a history of significant side effects after the consumption of caffeine.
- Deemed unhealthy/unable to perform exercise determined by PAR-Q
- Shift worker or having travelled out of the UK time zone within the last month of testing
- Muscle related injury or broken/fractured bone within the past 3 years Diagnosed sleep disorder
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: ABCDE
Control, Placebo, Caffeine, 1000m, 2000m, |
300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.
Autres noms:
Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)
Autres noms:
No pill control intended to act as a comparator for both Hypoxia and caffeine analysis
Autres noms:
Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.
Autres noms:
Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.
Autres noms:
|
|
Expérimental: BCDEA
Placebo, Caffeine, 1000m, 2000m, Control, |
300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.
Autres noms:
Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)
Autres noms:
No pill control intended to act as a comparator for both Hypoxia and caffeine analysis
Autres noms:
Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.
Autres noms:
Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.
Autres noms:
|
|
Expérimental: CDEAB
Caffeine, 1000m, 2000m, Control, Placebo, |
300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.
Autres noms:
Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)
Autres noms:
No pill control intended to act as a comparator for both Hypoxia and caffeine analysis
Autres noms:
Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.
Autres noms:
Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.
Autres noms:
|
|
Expérimental: DEABC
2000m, Control, Placebo, Caffeine, 1000m, |
300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.
Autres noms:
Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)
Autres noms:
No pill control intended to act as a comparator for both Hypoxia and caffeine analysis
Autres noms:
Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.
Autres noms:
Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.
Autres noms:
|
|
Expérimental: EABCD
1000m, 2000m, Control, Placebo, Caffeine, Caffeine, |
300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.
Autres noms:
Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)
Autres noms:
No pill control intended to act as a comparator for both Hypoxia and caffeine analysis
Autres noms:
Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.
Autres noms:
Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
4km time to completion
Délai: 5 weeks
|
How long does the participant take to complete 4km cycling |
5 weeks
|
|
Average power
Délai: 5 weekas
|
Average power sustained through the 4km |
5 weekas
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cognitive function
Délai: 5 weeks
|
Stroop word-colour interference test |
5 weeks
|
|
Witty
Délai: 5 weeks
|
Light reaction test |
5 weeks
|
|
Memory test
Délai: 5 weeks
|
Rey's Auditory Verbal Learning test |
5 weeks
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Signes et symptômes respiratoires
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Hypoxie
- Composés de soufre
- Produits chimiques organiques
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Acides carboxyliques
- Alcaloïdes
- Anilides
- Amides
- Composés aniline
- Amines
- Acétanilides
- Purinones
- Purines
- Acides, carbocyclique
- bêta-lactams
- Lactame
- Céphalosporines
- Thiazines
- Phénylpropionates
- Xanthines
- Acétaminophène
- Caféine
- Ibuprofène
- Céphalexine
- 2-(3',4'-dihydroxyphenyl)ethylene sulfate
- 5'-palmitoyl cytarabine
- temoporfin-polyethylene glycol conjugate
Autres numéros d'identification d'étude
- 261020LJMUSPSREC348
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .