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A Clinical Trial to Evaluate the Effects of the Edge+Ease PM+AM System on Mood, Mental Clarity, Sleep Quality, and Digestive Wellbeing

18 de julho de 2026 atualizado por: Edge+Ease

This is a decentralized, single-arm, open-label clinical trial evaluating the effects of the Edge+Ease PM+AM dietary supplement system on sleep quality, mood, mental clarity, focus, and digestive comfort in 35 generally healthy adults aged 18-65 years over 12 weeks of daily use.

Participants will take the Edge+Ease PM product (one serving of powder mixed in approximately 150-250 mL water) in the evening approximately 60-90 minutes before bedtime, and the Edge+Ease AM product (two capsules) in the morning with food. All study activities are conducted remotely via the Citruslabs platform. Participants will complete questionnaires at Baseline, Week 4, Week 8, and Week 12, and will wear a Fitbit continuously beginning 7 days before product use through the end of the 12-week intervention period to provide objective sleep data.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Estimado)

35

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.

Contato de estudo

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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • Male and female adults aged 18 to 65 years.
  • Self-reports difficulty falling asleep, staying asleep, or having poor sleep quality overall, in the last 4 weeks.
  • Self-reports seeking support in at least one of the following domains: Difficulty switching off, perceived stress load, mental overload, next-day mental fatigue, reduced mental clarity or reduced cognitive readiness.
  • Generally healthy.
  • Willing and able to take the PM product (one serving mixed in water) in the evening and the AM product (two capsules with food) in the morning daily for 12 weeks.
  • Willing to maintain current diet, exercise, caffeine, alcohol, and sleep routines for the duration of the study.
  • Willing to wear a Fitbit continuously during the trial, and for 7 days prior to starting the test product.
  • Resides in the United States.

Exclusion Criteria:

  • Known allergy or hypersensitivity to any ingredient in the test product.
  • Currently pregnant, breastfeeding, or trying to conceive, or will be during the study period.
  • Currently undergoing treatment for cancer, or have had a serious illness requiring hospitalization in the last 3 months.
  • Diagnosed severe psychiatric disorder (e.g., bipolar disorder, schizophrenia, major depressive disorder requiring active treatment adjustment) that, in the judgment of the Investigator, would compromise participation or interpretation of results.
  • Diagnosed inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), celiac disease, or other significant gastrointestinal condition requiring active management.
  • Current use of prescription antidepressants/anxiolytics, or other prescription neurologically-active medications that have been initiated or had a dose change within the past 90 days.
  • Current use of prescription sleep medications.
  • Regular use (i.e. more than once per week) of melatonin, sedating antihistamines, CBD/THC used for sleep, valerian, ashwagandha, or other sleep-targeted supplements.
  • Initiation of a new dietary supplement targeted at sleep, mood, cognition, or digestion within the 30 days prior to enrollment, or planning to start such a supplement during the study.
  • Heavy drinkers, defined as more than 8 alcoholic drinks per week for women and more than 15 alcoholic drinks per week for men.
  • Currently taking thyroid medication.
  • Currently testing, or plan to in the next 12 weeks, a product for another research study.

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: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Edge+ease PM Arm
All enrolled participants receive the Edge+Ease PM+AM system daily for 12 weeks. The PM product (powder) is taken as one serving mixed in approximately 150-250 mL water, around 60-90 minutes before intended bedtime, ideally after dinner.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Fitbit-measured sleep quality score
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in Fitbit sleep quality score from baseline, based on the average of three days per time point
Baseline, Week 4, Week 8, and Week 12
Change in Fitbit-measured time asleep
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in total time asleep from baseline, measured via Fitbit, based on the average of three days per time point
Baseline, Week 4, Week 8, and Week 12
Change in Fitbit-measured time awake
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in time awake from baseline, measured via Fitbit, based on the average of three days per time point
Baseline, Week 4, Week 8, and Week 12
Change in Fitbit-measured deep sleep
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in deep sleep duration from baseline, measured via Fitbit, based on the average of three days per time point
Baseline, Week 4, Week 8, and Week 12
Change in Fitbit-measured REM sleep
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in REM sleep duration from baseline, measured via Fitbit, based on the average of three days per time point
Baseline, Week 4, Week 8, and Week 12
Change in Fitbit-measured light sleep
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in light sleep duration from baseline, measured via Fitbit, based on the average of three days per time point
Baseline, Week 4, Week 8, and Week 12
Change in self-reported perceived sleep quality
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in perceived sleep quality assessed via questionnaire including the validated Sleep Quality Scale
Baseline, Week 4, Week 8, and Week 12
Change in self-reported sleep satisfaction
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in sleep satisfaction assessed via questionnaire including the validated Sleep Quality Scale
Baseline, Week 4, Week 8, and Week 12
Change in self-reported waking refreshed
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported waking refreshed assessed via questionnaire including the validated Sleep Quality Scale
Baseline, Week 4, Week 8, and Week 12
Change in self-reported morning readiness
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported morning readiness assessed via questionnaire including the validated Sleep Quality Scale
Baseline, Week 4, Week 8, and Week 12

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in self-reported mood
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported mood assessed via questionnaire administered through the study platform
Baseline, Week 4, Week 8, and Week 12
Change in self-reported calm
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported calm assessed via questionnaire administered through the study platform
Baseline, Week 4, Week 8, and Week 12
Change in self-reported evening wind-down
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported evening wind-down assessed via questionnaire administered through the study platform
Baseline, Week 4, Week 8, and Week 12
Change in self-reported emotional steadiness
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported emotional steadiness assessed via questionnaire administered through the study platform
Baseline, Week 4, Week 8, and Week 12
Change in self-reported irritability
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported irritability assessed via questionnaire administered through the study platform
Baseline, Week 4, Week 8, and Week 12
Change in self-reported mental clarity
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported mental clarity assessed via questionnaire administered through the study platform
Baseline, Week 4, Week 8, and Week 12
Change in self-reported focus
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported focus assessed via questionnaire administered through the study platform
Baseline, Week 4, Week 8, and Week 12
Change in self-reported digestive comfort
Prazo: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported digestive comfort assessed via questionnaire administered through the study platform
Baseline, Week 4, Week 8, and Week 12
Participant perception of product effect on sleep quality
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on sleep quality assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Participant perception of product effect on sleep satisfaction
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on sleep satisfaction assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Participant perception of product effect on waking refreshed
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on waking refreshed assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Participant perception of product effect on morning readiness
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on morning readiness assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Participant perception of product effect on mood
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on mood assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Participant perception of product effect on calmness
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on calmness assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Participant perception of product effect on evening wind-down
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on evening wind-down assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Participant perception of product effect on task initiation
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on task initiation assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Participant perception of product effect on mental clarity
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on mental clarity assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Participant perception of product effect on focus
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on focus assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Participant perception of product effect on digestive comfort
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on digestive comfort assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Participant perception of product effect on gut health
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on gut health assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Participant perception of product effect on overall wellness
Prazo: Week 4, Week 8, and Week 12
Participant-reported perception of product effects on overall wellness assessed via questionnaire administered through the study platform
Week 4, Week 8, and Week 12
Incidence of adverse events
Prazo: Throughout study (up to 12 weeks)
Number and percentage of participants experiencing adverse events, characterized by severity and relationship to study product, assessed via self-report questionnaire and investigator review
Throughout study (up to 12 weeks)
Severity of adverse events
Prazo: Throughout study (up to 12 weeks)
Severity rating (mild, moderate, severe) of adverse events assessed via self-report questionnaire and investigator review
Throughout study (up to 12 weeks)
Participant discontinuations due to adverse events
Prazo: Throughout study (up to 12 weeks)
Number of participants who discontinue the study intervention due to adverse events
Throughout study (up to 12 weeks)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

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 (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

18 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de julho de 2026

Primeira postagem (Real)

23 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

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 .

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