Brain Fog, Digestive Comfort, Evening Wind-Down, Focus, Mental Clarity, Mood, Sleep Quality
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTEdge+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.
Sponsors
Edge+Ease
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fitbit-measured sleep quality score | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline, Week 4, Week 8, and Week 12 | Mean change in self-reported morning readiness assessed via questionnaire including the validated Sleep Quality Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported mood | Baseline, Week 4, Week 8, and Week 12 | Mean change in self-reported mood assessed via questionnaire administered through the study platform |
| Change in self-reported calm | Baseline, Week 4, Week 8, and Week 12 | Mean change in self-reported calm assessed via questionnaire administered through the study platform |
| Change in self-reported evening wind-down | Baseline, Week 4, Week 8, and Week 12 | Mean change in self-reported evening wind-down assessed via questionnaire administered through the study platform |
| Change in self-reported emotional steadiness | Baseline, Week 4, Week 8, and Week 12 | Mean change in self-reported emotional steadiness assessed via questionnaire administered through the study platform |
| Change in self-reported irritability | Baseline, Week 4, Week 8, and Week 12 | Mean change in self-reported irritability assessed via questionnaire administered through the study platform |
| Change in self-reported mental clarity | Baseline, Week 4, Week 8, and Week 12 | Mean change in self-reported mental clarity assessed via questionnaire administered through the study platform |
| Change in self-reported focus | Baseline, Week 4, Week 8, and Week 12 | Mean change in self-reported focus assessed via questionnaire administered through the study platform |
| Change in self-reported digestive comfort | Baseline, Week 4, Week 8, and Week 12 | Mean change in self-reported digestive comfort assessed via questionnaire administered through the study platform |
| Participant perception of product effect on sleep quality | Week 4, Week 8, and Week 12 | Participant-reported perception of product effects on sleep quality assessed via questionnaire administered through the study platform |
| Participant perception of product effect on sleep satisfaction | Week 4, Week 8, and Week 12 | Participant-reported perception of product effects on sleep satisfaction assessed via questionnaire administered through the study platform |
| Participant perception of product effect on waking refreshed | Week 4, Week 8, and Week 12 | Participant-reported perception of product effects on waking refreshed assessed via questionnaire administered through the study platform |
| Participant perception of product effect on morning readiness | Week 4, Week 8, and Week 12 | Participant-reported perception of product effects on morning readiness assessed via questionnaire administered through the study platform |
| Participant perception of product effect on mood | Week 4, Week 8, and Week 12 | Participant-reported perception of product effects on mood assessed via questionnaire administered through the study platform |
| Participant perception of product effect on calmness | Week 4, Week 8, and Week 12 | Participant-reported perception of product effects on calmness assessed via questionnaire administered through the study platform |
| Participant perception of product effect on evening wind-down | 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 |
| Participant perception of product effect on task initiation | Week 4, Week 8, and Week 12 | Participant-reported perception of product effects on task initiation assessed via questionnaire administered through the study platform |
| Participant perception of product effect on mental clarity | Week 4, Week 8, and Week 12 | Participant-reported perception of product effects on mental clarity assessed via questionnaire administered through the study platform |
| Participant perception of product effect on focus | Week 4, Week 8, and Week 12 | Participant-reported perception of product effects on focus assessed via questionnaire administered through the study platform |
| Participant perception of product effect on digestive comfort | Week 4, Week 8, and Week 12 | Participant-reported perception of product effects on digestive comfort assessed via questionnaire administered through the study platform |
| Participant perception of product effect on gut health | Week 4, Week 8, and Week 12 | Participant-reported perception of product effects on gut health assessed via questionnaire administered through the study platform |
| Participant perception of product effect on overall wellness | Week 4, Week 8, and Week 12 | Participant-reported perception of product effects on overall wellness assessed via questionnaire administered through the study platform |
| Incidence of adverse events | 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 |
| Severity of adverse events | Throughout study (up to 12 weeks) | Severity rating (mild, moderate, severe) of adverse events assessed via self-report questionnaire and investigator review |
| Participant discontinuations due to adverse events | Throughout study (up to 12 weeks) | Number of participants who discontinue the study intervention due to adverse events |
Contacts
CONTACTPatrick Renner
Outcome results
None listed