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

Overview

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 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.

Primary outcome measures

• Change in Fitbit-measured sleep quality score [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in Fitbit-measured time asleep [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in Fitbit-measured time awake [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in Fitbit-measured deep sleep [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in Fitbit-measured REM sleep [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in Fitbit-measured light sleep [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported perceived sleep quality [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported sleep satisfaction [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported waking refreshed [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported morning readiness [Time frame: Baseline, Week 4, Week 8, and Week 12]

Secondary outcome measures (12)

• Change in self-reported mood [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported calm [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported evening wind-down [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported emotional steadiness [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported irritability [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported mental clarity [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported focus [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Change in self-reported digestive comfort [Time frame: Baseline, Week 4, Week 8, and Week 12]
• Participant perception of product effect on sleep quality [Time frame: Week 4, Week 8, and Week 12]
• Participant perception of product effect on sleep satisfaction [Time frame: Week 4, Week 8, and Week 12]
• Participant perception of product effect on waking refreshed [Time frame: Week 4, Week 8, and Week 12]
• Participant perception of product effect on morning readiness [Time frame: Week 4, Week 8, and Week 12]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07721506 · EDGEE-27795

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗