Dose Effect of a Plant Extract on Fatigue
14 janvier 2020 mis à jour par: PepsiCo Global R&D
Effects of Two Doses of a Plant Extract on Mental and Physical Fatigue
Test the short-term effects of the acute consumption of two separate beverages containing different concentrations of polyphenols, a beverage containing 75 mg of caffeine and a flavored placebo beverage on mental energy and physical performance
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
28
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Georgia
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Athens, Georgia, États-Unis, 30602
- University of Georgia
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 49 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- 18-49 years of age
- Self-report of good health
- Physical activity requirement: Recreationally active (exercise ≥3 times per week for >30 minutes per session; both cyclists and non-cyclists may enroll)
Exclusion Criteria:
- Under the care of a physician
- Visual impairment that cannot be corrected with glasses or contact lenses
- Inability to perform high intensity exercise (defined perceptually as exercise that feels at least "hard" and this is usually quantified using the Borg 6 to 20 scale. High intensity cycling exercise is defined objectively as exercise causing a high heart rate, defined as a heart rate that is equal to or greater than 70% of heart rate reserve.)
- Inability to adequately perform the cognitive tasks (i.e., cannot complete the task due to -inability to understand instructions or >50% incorrect responses)
- Presence of current or chronic gastrointestinal, sleep or psychiatric disorder
- Pregnant/lactating
- Current smoker
- Report illegal drug use
- Report hypersensitivity to caffeine
- Food allergies/intolerances/sensitivities (including coffee or related foods/beverages/products)
- Current use of dietary supplements, or prescription medication except for oral contraceptives
- Unwillingness to abstain from over the counter medications (e.g. NSAIDS, allergy medications) and caffeine/coffee/foods high in polyphenols for 12 hours prior to the study
- Unwilling to refrain from consuming apple and grapefruit products on study days and 12 hours prior to test days.
- Participation in another clinical trial within the past 30 days or participation in another PepsiCo trial in the past 6 months
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Flavored Beverage Mix 1
Flavored still beverage
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Consume one beverage at the beginning of each visit of the cross-over sequence
|
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Expérimental: Flavored Beverage Mix 2
Flavored still beverage with polyphenols, concentration 1
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Consume one beverage at the beginning of each visit of the cross-over sequence
|
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Expérimental: Flavored Beverage Mix 3
Flavored still beverage with polyphenols, concentration 2
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Consume one beverage at the beginning of each visit of the cross-over sequence
|
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Expérimental: Flavored Beverage Mix 4
Flavored still beverage with caffeine
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Consume one beverage at the beginning of each visit of the cross-over sequence
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Subjective mental energy: Cognitive test battery
Délai: Baseline and 60 min post treatment
|
Changes in subjective measures of mental alertness and mental fatigue through computer administered cognitive test battery domains of short-term memory, attention and mood.
Tasks are word presentation, word recognition, picture presentation, picture recognition, Cognitive Demand Battery (CDB) serial 3 and serial 7 subtraction, and Bakan task/Rapid Visual Information Processing (RVIP).
Performance measures: % correct, % errors and response time in milliseconds.
|
Baseline and 60 min post treatment
|
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Subjective mental energy: VAS for mental alertness
Délai: Baseline and 60 min post treatment
|
Changes in subjective ratings of mental alertness following computer administered cognitively fatiguing tasks.
Visual Analog Scale (VAS) for mental alertness has the score range 0-100 (from not at all to extremely).
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Baseline and 60 min post treatment
|
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Subjective mental energy: VAS for motivation
Délai: Baseline and 60 min post treatment
|
Changes in subjective ratings of motivation following computer administered cognitively fatiguing tasks.
Visual Analog Scale (VAS) for motivation has the score range 0-100 (from not at all to extremely).
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Baseline and 60 min post treatment
|
|
Subjective mental energy: VAS for mental fatigue
Délai: Baseline and 60 min post treatment
|
Changes in subjective ratings of fatigue following computer administered cognitively fatiguing tasks.
Visual Analog Scale (VAS) for fatigue has the score range 0-100 (from not at all to extremely).
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Baseline and 60 min post treatment
|
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Subjective mental and physical energy: VAS for mental and physical state and trait energy and fatigue (EFS State Scales)
Délai: Baseline and 60 min post treatment
|
Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks.
Mental and Physical State and Trait Energy and Fatigue Scales (EFS State Scales) consist of 12 VAS items to measure intensity of current feeling of physical energy and fatigue and mental energy and fatigue (3 sub-scales each).
Score range: The 3 items from each sub-scale are summed and scores for each sub-scale range from 0-300 (none to strongest).
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Baseline and 60 min post treatment
|
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Subjective mental energy: VAS for mood
Délai: Baseline and 60 min post treatment
|
Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks.
The Bond-Lader test uses 16 Visual Analog Scales (VAS) to measure different aspects of mood, with score range 0-100 for each scale (from absence of feeling to presence of feeling).
|
Baseline and 60 min post treatment
|
|
Subjective mental energy: VAS for caffeine symptoms
Délai: Baseline and 60 min post treatment
|
Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks.
Caffeine symptoms are measured on paper using 8 Visual Analog Scales (VAS) with score range 0-100 (from not at all to extremely).
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Baseline and 60 min post treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physical performance
Délai: During the last 3 minutes of 23 min high intensity cycling exercise (10 x 1 min work intervals each followed by 1 min rest. No rest after final interval, 3 min max power from minutes 20-23.
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Mean power output in a timed cycling trial following post-treatment cognitive test battery and caffeine symptom VAS.
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During the last 3 minutes of 23 min high intensity cycling exercise (10 x 1 min work intervals each followed by 1 min rest. No rest after final interval, 3 min max power from minutes 20-23.
|
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Physical Fatigue
Délai: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Subjective categorical scale, score range 0-7, higher score indicates greater feeling of physical fatigue
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After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Alertness
Délai: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Subjective categorical scale, score range 1-7, higher score indicates greater alertness meaning a greater feeling of energy
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After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Effort
Délai: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Subjective categorical scale, Borg Ratings of Perceived Exertion (RPE) measures perception of effort, score range 6-20.
Higher score indicates greater effort.
17 or greater generally indicates maximal effort
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After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Quadriceps muscle pain
Délai: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
|
Subjective categorical scale with ratio-like properties, scale 0-10 with open-ended option for ratings greater than but proportional to 10. Higher scores indicate greater perception of pain in the quadriceps
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After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Patrick J O'Connor, PhD, University of Georgia
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
29 janvier 2019
Achèvement primaire (Réel)
6 décembre 2019
Achèvement de l'étude (Réel)
6 décembre 2019
Dates d'inscription aux études
Première soumission
26 février 2019
Première soumission répondant aux critères de contrôle qualité
8 mars 2019
Première publication (Réel)
11 mars 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 janvier 2020
Dernière vérification
1 janvier 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PEP-1807
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Oui
Description du régime IPD
IPD will be kept securely at U. Georgia for several years and can be accessed upon request by contacting Dr. Pat O'Connor (poconnor@uga.edu)
Délai de partage IPD
After publication
Critères d'accès au partage IPD
Open access, upon request
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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 .