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

Обзор

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.

Вмешательства

• Пищевая добавка Edge+ease PM
  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.

Первичные конечные точки

• Change in Fitbit-measured sleep quality score [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in Fitbit-measured time asleep [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in Fitbit-measured time awake [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in Fitbit-measured deep sleep [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in Fitbit-measured REM sleep [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in Fitbit-measured light sleep [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported perceived sleep quality [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported sleep satisfaction [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported waking refreshed [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported morning readiness [Срок оценки: Baseline, Week 4, Week 8, and Week 12]

Вторичные конечные точки (12)

• Change in self-reported mood [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported calm [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported evening wind-down [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported emotional steadiness [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported irritability [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported mental clarity [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported focus [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported digestive comfort [Срок оценки: Baseline, Week 4, Week 8, and Week 12]
• Participant perception of product effect on sleep quality [Срок оценки: Week 4, Week 8, and Week 12]
• Participant perception of product effect on sleep satisfaction [Срок оценки: Week 4, Week 8, and Week 12]
• Participant perception of product effect on waking refreshed [Срок оценки: Week 4, Week 8, and Week 12]
• Participant perception of product effect on morning readiness [Срок оценки: Week 4, Week 8, and Week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07721506 · EDGEE-27795

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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