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

NCT07721506 | Not Yet Recruiting

• 1 other identifier: EDGEE-27795
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Quality; Mood; Mental Clarity; Brain Fog; Digestive Comfort; Focus; Evening Wind-Down

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (24)

• 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

Study Arms (1)

Edge+ease PM Arm

EXPERIMENTAL

Dietary Supplement: Edge+ease PM

Interventions

Edge+ease PM DIETARY_SUPPLEMENT

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.

Edge+ease PM Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edge+Ease: lead
• Citruslabs: collaborator

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Mental Fatigue

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Central Study Contacts

Patrick Renner

CONTACT

4242450284; hello@citruslabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07