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Dose Effect of a Plant Extract on Fatigue

14. Januar 2020 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

28

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Georgia
      • Athens, Georgia, Vereinigte Staaten, 30602
        • University of Georgia

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 49 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Flavored Beverage Mix 1
Flavored still beverage
Sonstiges: Flavored beverage
Consume one beverage at the beginning of each visit of the cross-over sequence
Experimental: Flavored Beverage Mix 2
Flavored still beverage with polyphenols, concentration 1
Sonstiges: Flavored beverage
Consume one beverage at the beginning of each visit of the cross-over sequence
Experimental: Flavored Beverage Mix 3
Flavored still beverage with polyphenols, concentration 2
Sonstiges: Flavored beverage
Consume one beverage at the beginning of each visit of the cross-over sequence
Experimental: Flavored Beverage Mix 4
Flavored still beverage with caffeine
Sonstiges: Flavored beverage
Consume one beverage at the beginning of each visit of the cross-over sequence

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Subjective mental energy: Cognitive test battery
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Physical performance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

PepsiCo Global R&D

Ermittler

  • Hauptermittler: Patrick J O'Connor, PhD, University of Georgia

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

29. Januar 2019

Primärer Abschluss (Tatsächlich)

6. Dezember 2019

Studienabschluss (Tatsächlich)

6. Dezember 2019

Studienanmeldedaten

Zuerst eingereicht

26. Februar 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. März 2019

Zuerst gepostet (Tatsächlich)

11. März 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Januar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Januar 2020

Zuletzt verifiziert

1. Januar 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PEP-1807

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

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)

IPD-Sharing-Zeitrahmen

After publication

IPD-Sharing-Zugriffskriterien

Open access, upon request

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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