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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

2026年7月18日 更新者: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.

調査の概要

研究の種類

介入

入学 (推定)

35

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Fitbit-measured sleep quality score
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in self-reported mood
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Throughout study (up to 12 weeks)
Number of participants who discontinue the study intervention due to adverse events
Throughout study (up to 12 weeks)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2026年7月18日

QC基準を満たした最初の提出物

2026年7月18日

最初の投稿 (実際)

2026年7月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月23日

QC基準を満たした最後の更新が送信されました

2026年7月18日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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