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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Quality; Mood; Brain Fog; Focus; Mental Clarity; Digestive Comfort; Evening Wind-Down
• Intervention / Treatment: Dietary supplement: Edge+ease PM

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Renner; Phone Number: 4242450284; Email: hello@citruslabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Edge+ease PM Arm	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fitbit-measured sleep quality score	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	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	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	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	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	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	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	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	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	Mean change in self-reported morning readiness assessed via questionnaire including the validated Sleep Quality Scale	Baseline, Week 4, Week 8, and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported mood	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	Number of participants who discontinue the study intervention due to adverse events	Throughout study (up to 12 weeks)

Collaborators and Investigators

• Sponsor: Edge+Ease
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 18, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Fatigue; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Sleep Initiation and Maintenance Disorders; Mental Fatigue
• Other Study ID Numbers: EDGEE-27795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No