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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

2026년 7월 18일 업데이트: 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.

연구 개요

연구 유형

중재적

등록 (추정된)

35

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Fitbit-measured sleep quality score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in self-reported mood
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Throughout study (up to 12 weeks)
Number of participants who discontinue the study intervention due to adverse events
Throughout study (up to 12 weeks)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2026년 12월 1일

연구 등록 날짜

최초 제출

2026년 7월 18일

QC 기준을 충족하는 최초 제출

2026년 7월 18일

처음 게시됨 (실제)

2026년 7월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 18일

마지막으로 확인됨

2026년 7월 1일

추가 정보

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미정

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아니

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