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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 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

35

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.

Contatto studio

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

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

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: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Fitbit-measured sleep quality score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in self-reported mood
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Throughout study (up to 12 weeks)
Number of participants who discontinue the study intervention due to adverse events
Throughout study (up to 12 weeks)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

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 (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

18 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

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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