Dose Effect of a Plant Extract on Fatigue
14 de janeiro de 2020 atualizado por: 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
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
28
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
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Georgia
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Athens, Georgia, Estados Unidos, 30602
- University of Georgia
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 49 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de 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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Experimental: 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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Experimental: 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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Experimental: 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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Subjective mental energy: Cognitive test battery
Prazo: 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.
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Baseline and 60 min post treatment
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Subjective mental energy: VAS for mental alertness
Prazo: 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
Prazo: 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
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Subjective mental energy: VAS for mental fatigue
Prazo: 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)
Prazo: 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
Prazo: 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).
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Baseline and 60 min post treatment
|
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Subjective mental energy: VAS for caffeine symptoms
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Physical performance
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Patrick J O'Connor, PhD, University of Georgia
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
29 de janeiro de 2019
Conclusão Primária (Real)
6 de dezembro de 2019
Conclusão do estudo (Real)
6 de dezembro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
26 de fevereiro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de março de 2019
Primeira postagem (Real)
11 de março de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de janeiro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de janeiro de 2020
Última verificação
1 de janeiro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PEP-1807
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
Descrição do plano 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)
Prazo de Compartilhamento de IPD
After publication
Critérios de acesso de compartilhamento IPD
Open access, upon request
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .