A Clinical Trial to Evaluate the Effects of the Edge+Ease PM+AM System on Mood, Mental Clarity, Sleep Quality, and Digestive Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 主要终点
- Change in Fitbit-measured sleep quality score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Edge+ease PM Arm
干预措施: Edge+ease PM (Dietary Supplement)
结局指标
主要结局
Change in Fitbit-measured sleep quality score
时间窗: 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
Change in Fitbit-measured time asleep
时间窗: 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
Change in Fitbit-measured time awake
时间窗: 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
Change in Fitbit-measured deep sleep
时间窗: 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
Change in Fitbit-measured REM sleep
时间窗: 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
Change in Fitbit-measured light sleep
时间窗: 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
Change in self-reported perceived sleep quality
时间窗: Baseline, Week 4, Week 8, and Week 12
Mean change in perceived sleep quality assessed via questionnaire including the validated Sleep Quality Scale
Change in self-reported sleep satisfaction
时间窗: Baseline, Week 4, Week 8, and Week 12
Mean change in sleep satisfaction assessed via questionnaire including the validated Sleep Quality Scale
Change in self-reported waking refreshed
时间窗: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported waking refreshed assessed via questionnaire including the validated Sleep Quality Scale
Change in self-reported morning readiness
时间窗: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported morning readiness assessed via questionnaire including the validated Sleep Quality Scale
次要结局
- Change in self-reported mood(Baseline, Week 4, Week 8, and Week 12)
- Change in self-reported calm(Baseline, Week 4, Week 8, and Week 12)
- Change in self-reported evening wind-down(Baseline, Week 4, Week 8, and Week 12)
- Change in self-reported emotional steadiness(Baseline, Week 4, Week 8, and Week 12)
- Change in self-reported irritability(Baseline, Week 4, Week 8, and Week 12)
- Change in self-reported mental clarity(Baseline, Week 4, Week 8, and Week 12)
- Change in self-reported focus(Baseline, Week 4, Week 8, and Week 12)
- Change in self-reported digestive comfort(Baseline, Week 4, Week 8, and Week 12)
- Participant perception of product effect on sleep quality(Week 4, Week 8, and Week 12)
- Participant perception of product effect on sleep satisfaction(Week 4, Week 8, and Week 12)
- Participant perception of product effect on waking refreshed(Week 4, Week 8, and Week 12)
- Participant perception of product effect on morning readiness(Week 4, Week 8, and Week 12)
- Participant perception of product effect on mood(Week 4, Week 8, and Week 12)
- Participant perception of product effect on calmness(Week 4, Week 8, and Week 12)
- Participant perception of product effect on evening wind-down(Week 4, Week 8, and Week 12)
- Participant perception of product effect on task initiation(Week 4, Week 8, and Week 12)
- Participant perception of product effect on mental clarity(Week 4, Week 8, and Week 12)
- Participant perception of product effect on focus(Week 4, Week 8, and Week 12)
- Participant perception of product effect on digestive comfort(Week 4, Week 8, and Week 12)
- Participant perception of product effect on gut health(Week 4, Week 8, and Week 12)
- Participant perception of product effect on overall wellness(Week 4, Week 8, and Week 12)
- Incidence of adverse events(Throughout study (up to 12 weeks))
- Severity of adverse events(Throughout study (up to 12 weeks))
- Participant discontinuations due to adverse events(Throughout study (up to 12 weeks))