Dose Effect of a Plant Extract on Fatigue
14 gennaio 2020 aggiornato da: 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
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
28
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Georgia
-
Athens, Georgia, Stati Uniti, 30602
- University of Georgia
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 49 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: Flavored Beverage Mix 1
Flavored still beverage
|
Consume one beverage at the beginning of each visit of the cross-over sequence
|
|
Sperimentale: Flavored Beverage Mix 2
Flavored still beverage with polyphenols, concentration 1
|
Consume one beverage at the beginning of each visit of the cross-over sequence
|
|
Sperimentale: Flavored Beverage Mix 3
Flavored still beverage with polyphenols, concentration 2
|
Consume one beverage at the beginning of each visit of the cross-over sequence
|
|
Sperimentale: Flavored Beverage Mix 4
Flavored still beverage with caffeine
|
Consume one beverage at the beginning of each visit of the cross-over sequence
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Subjective mental energy: Cognitive test battery
Lasso di tempo: 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
|
|
Subjective mental energy: VAS for mental alertness
Lasso di tempo: 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).
|
Baseline and 60 min post treatment
|
|
Subjective mental energy: VAS for motivation
Lasso di tempo: 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).
|
Baseline and 60 min post treatment
|
|
Subjective mental energy: VAS for mental fatigue
Lasso di tempo: 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).
|
Baseline and 60 min post treatment
|
|
Subjective mental and physical energy: VAS for mental and physical state and trait energy and fatigue (EFS State Scales)
Lasso di tempo: 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).
|
Baseline and 60 min post treatment
|
|
Subjective mental energy: VAS for mood
Lasso di tempo: 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
Lasso di tempo: 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).
|
Baseline and 60 min post treatment
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Physical performance
Lasso di tempo: 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.
|
Mean power output in a timed cycling trial following post-treatment cognitive test battery and caffeine symptom VAS.
|
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.
|
|
Physical Fatigue
Lasso di tempo: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
|
Subjective categorical scale, score range 0-7, higher score indicates greater feeling of physical fatigue
|
After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
|
|
Alertness
Lasso di tempo: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
|
Subjective categorical scale, score range 1-7, higher score indicates greater alertness meaning a greater feeling of energy
|
After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
|
|
Effort
Lasso di tempo: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
|
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
|
After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
|
|
Quadriceps muscle pain
Lasso di tempo: 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
|
After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Patrick J O'Connor, PhD, University of Georgia
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
29 gennaio 2019
Completamento primario (Effettivo)
6 dicembre 2019
Completamento dello studio (Effettivo)
6 dicembre 2019
Date di iscrizione allo studio
Primo inviato
26 febbraio 2019
Primo inviato che soddisfa i criteri di controllo qualità
8 marzo 2019
Primo Inserito (Effettivo)
11 marzo 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 gennaio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 gennaio 2020
Ultimo verificato
1 gennaio 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PEP-1807
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Sì
Descrizione del piano 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)
Periodo di condivisione IPD
After publication
Criteri di accesso alla condivisione IPD
Open access, upon request
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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