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Dose Effect of a Plant Extract on Fatigue

14. januar 2020 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Georgia
      • Athens, Georgia, Forenede Stater, 30602
        • University of Georgia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 49 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Flavored Beverage Mix 1
Flavored still beverage
Andet: Flavored beverage
Consume one beverage at the beginning of each visit of the cross-over sequence
Eksperimentel: Flavored Beverage Mix 2
Flavored still beverage with polyphenols, concentration 1
Andet: Flavored beverage
Consume one beverage at the beginning of each visit of the cross-over sequence
Eksperimentel: Flavored Beverage Mix 3
Flavored still beverage with polyphenols, concentration 2
Andet: Flavored beverage
Consume one beverage at the beginning of each visit of the cross-over sequence
Eksperimentel: Flavored Beverage Mix 4
Flavored still beverage with caffeine
Andet: Flavored beverage
Consume one beverage at the beginning of each visit of the cross-over sequence

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subjective mental energy: Cognitive test battery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical performance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

PepsiCo Global R&D

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. januar 2019

Primær færdiggørelse (Faktiske)

6. december 2019

Studieafslutning (Faktiske)

6. december 2019

Datoer for studieregistrering

Først indsendt

26. februar 2019

Først indsendt, der opfyldte QC-kriterier

8. marts 2019

Først opslået (Faktiske)

11. marts 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PEP-1807

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

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-delingstidsramme

After publication

IPD-delingsadgangskriterier

Open access, upon request

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Mental Energy

Kliniske forsøg med Flavored beverage

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