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NCT Number: NCT07721506

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.

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Key information

Conditions

Sleep Quality Behavior Behavioral Symptoms Brain Fog Digestive Comfort Dyssomnias Evening Wind-Down Fatigue Focus Mental Clarity Mental Disorders Mental Fatigue Mood Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Fitbit-measured sleep quality score

    Time frame: 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

  2. Change in Fitbit-measured time asleep

    Time frame: 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

  3. Change in Fitbit-measured time awake

    Time frame: 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

  4. Change in Fitbit-measured deep sleep

    Time frame: 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

  5. Change in Fitbit-measured REM sleep

    Time frame: 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

  6. Change in Fitbit-measured light sleep

    Time frame: 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

  7. Change in self-reported perceived sleep quality

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in perceived sleep quality assessed via questionnaire including the validated Sleep Quality Scale

  8. Change in self-reported sleep satisfaction

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in sleep satisfaction assessed via questionnaire including the validated Sleep Quality Scale

  9. Change in self-reported waking refreshed

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in self-reported waking refreshed assessed via questionnaire including the validated Sleep Quality Scale

  10. Change in self-reported morning readiness

    Time frame: 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 outcomes

  1. Change in self-reported mood

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in self-reported mood assessed via questionnaire administered through the study platform

  2. Change in self-reported calm

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in self-reported calm assessed via questionnaire administered through the study platform

  3. Change in self-reported evening wind-down

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in self-reported evening wind-down assessed via questionnaire administered through the study platform

  4. Change in self-reported emotional steadiness

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in self-reported emotional steadiness assessed via questionnaire administered through the study platform

  5. Change in self-reported irritability

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in self-reported irritability assessed via questionnaire administered through the study platform

  6. Change in self-reported mental clarity

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in self-reported mental clarity assessed via questionnaire administered through the study platform

  7. Change in self-reported focus

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in self-reported focus assessed via questionnaire administered through the study platform

  8. Change in self-reported digestive comfort

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Mean change in self-reported digestive comfort assessed via questionnaire administered through the study platform

  9. Participant perception of product effect on sleep quality

    Time frame: Week 4, Week 8, and Week 12

    Participant-reported perception of product effects on sleep quality assessed via questionnaire administered through the study platform

  10. Participant perception of product effect on sleep satisfaction

    Time frame: Week 4, Week 8, and Week 12

    Participant-reported perception of product effects on sleep satisfaction assessed via questionnaire administered through the study platform

  11. Participant perception of product effect on waking refreshed

    Time frame: Week 4, Week 8, and Week 12

    Participant-reported perception of product effects on waking refreshed assessed via questionnaire administered through the study platform

  12. Participant perception of product effect on morning readiness

    Time frame: Week 4, Week 8, and Week 12

    Participant-reported perception of product effects on morning readiness assessed via questionnaire administered through the study platform

  13. Participant perception of product effect on mood

    Time frame: Week 4, Week 8, and Week 12

    Participant-reported perception of product effects on mood assessed via questionnaire administered through the study platform

  14. Participant perception of product effect on calmness

    Time frame: Week 4, Week 8, and Week 12

    Participant-reported perception of product effects on calmness assessed via questionnaire administered through the study platform

  15. Participant perception of product effect on evening wind-down

    Time frame: 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

  16. Participant perception of product effect on task initiation

    Time frame: Week 4, Week 8, and Week 12

    Participant-reported perception of product effects on task initiation assessed via questionnaire administered through the study platform

  17. Participant perception of product effect on mental clarity

    Time frame: Week 4, Week 8, and Week 12

    Participant-reported perception of product effects on mental clarity assessed via questionnaire administered through the study platform

  18. Participant perception of product effect on focus

    Time frame: Week 4, Week 8, and Week 12

    Participant-reported perception of product effects on focus assessed via questionnaire administered through the study platform

  19. Participant perception of product effect on digestive comfort

    Time frame: Week 4, Week 8, and Week 12

    Participant-reported perception of product effects on digestive comfort assessed via questionnaire administered through the study platform

  20. Participant perception of product effect on gut health

    Time frame: Week 4, Week 8, and Week 12

    Participant-reported perception of product effects on gut health assessed via questionnaire administered through the study platform

  21. Participant perception of product effect on overall wellness

    Time frame: Week 4, Week 8, and Week 12

    Participant-reported perception of product effects on overall wellness assessed via questionnaire administered through the study platform

  22. Incidence of adverse events

    Time frame: 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

  23. Severity of adverse events

    Time frame: Throughout study (up to 12 weeks)

    Severity rating (mild, moderate, severe) of adverse events assessed via self-report questionnaire and investigator review

  24. Participant discontinuations due to adverse events

    Time frame: Throughout study (up to 12 weeks)

    Number of participants who discontinue the study intervention due to adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick Renner

CONTACT

[email protected]

4242450284

Sponsors and collaborators

Lead sponsor

Edge+Ease

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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