Bonafide Sleep Supplement for Menopausal Women With Sleep Complaints

NCT07839312 | Completed

• 1 other identifier: Pro00083360
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

This open-label study was designed to evaluate whether a daily dietary sleep supplement could improve sleep quality and related daytime well-being in menopausal women aged 40 to 65 with sleep complaints. All participants received the study supplement for approximately 12 weeks, followed by a four-week period without the supplement to assess changes after discontinuation. Sleep quality, sleep and well-being complaints, product experience, safety, and tolerability were assessed throughout the study.

Conditions

Sleep Disturbance

Keywords

Menopause; Perimenopause; Postmenopause; Sleep Complaints; Sleep Disturbance; Sleep Quality; Sleep Onset Latency; Sleep Maintenance; Daytime Sleepiness; Morning Grogginess; Deep Sleep; Quality of Life; Women's Health

Outcome Measures

Primary Outcomes (15)

• Change in Morning Ease as Measured by a Visual Analog Scale (VAS)

  Change from baseline in self-reported difficulty leaving bed and beginning the day, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no difficulty, while a score of 100 indicates extreme difficulty that is nearly impossible to overcome. Lower scores indicate greater ease beginning the day.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days

• Change in Sleep-Onset Latency as Measured by a Visual Analog Scale (VAS)

  Change from baseline in self-reported time required to fall asleep, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates falling asleep almost immediately, while a score of 100 indicates substantial difficulty falling asleep. Lower scores indicate easier sleep initiation.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days

• Change in Sleep Disturbances as Measured by a Visual Analog Scale (VAS)

  Change from baseline in self-reported frequency of sleep disturbances measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no sleep disturbances and peaceful sleep every night, while a score of 100 indicates constant sleep disturbances every night. Lower scores indicate fewer sleep disturbances.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days

• Change in Wakefulness After Sleep Onset (WASO) as Measured by a Visual Analog Scale (VAS)

  Change from baseline in self-reported difficulty returning to sleep after awakening during the night, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no nighttime awakening, while a score of 100 indicates finding it very difficult or impossible to fall back asleep. Lower scores indicate better sleep maintenance.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days

• Change in Mental Confusion as Measured by a Visual Analog Scale (VAS)

  Change from baseline in self-reported mental confusion upon waking, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no mental confusion and clear, focused thoughts, while a score of 100 indicates intense mental confusion and substantial difficulty achieving clarity. Lower scores indicate less mental confusion.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days

• Change in Morning Grogginess as Measured by a Visual Analog Scale (VAS)

  Change from baseline in self-reported morning grogginess measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no grogginess and feeling fully alert upon waking, while a score of 100 indicates intense morning grogginess with marked drowsiness and lethargy. Lower scores indicate less morning grogginess.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days

• Change in Restfulness or Rejuvenation as Measured by a Visual Analog Scale (VAS)

  Change from baseline in self-reported restfulness or rejuvenation upon waking, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates feeling fully rested and rejuvenated, while a score of 100 indicates no sense of restfulness or rejuvenation. Lower scores indicate greater restfulness.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days

• Change in Deep Sleep as Measured by a Visual Analog Scale (VAS)

  Change from baseline in self-reported experience of deep, restorative sleep measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates consistently experiencing deep, uninterrupted, restorative sleep, while a score of 100 indicates experiencing no perceived deep sleep. Lower scores indicate greater perceived deep sleep.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days

• Change in Daytime Sleepiness as Measured by a Visual Analog Scale (VAS)

  Change from baseline in self-reported daytime sleepiness measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates feeling alert and energetic without daytime sleepiness, while a score of 100 indicates an overpowering urge to sleep or nap. Lower scores indicate less daytime sleepiness.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days

• Change in Sleep Satisfaction as Measured by a Visual Analog Scale (VAS)

  Change from baseline in self-reported satisfaction with sleep measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates being extremely satisfied with sleep, while a score of 100 indicates being extremely dissatisfied. Lower scores indicate greater sleep satisfaction.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days

• Change in Sleep Quality as Measured by a Visual Analog Scale (VAS)

  Change from baseline in self-reported overall sleep quality measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates excellent sleep quality, while a score of 100 indicates extremely poor sleep quality. Lower scores indicate better sleep quality.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days

• Change in Overall Quality of Life as Measured by a Visual Analog Scale (VAS)

  Change from baseline in self-reported overall quality of life measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates excellent quality of life and complete satisfaction, while a score of 100 indicates extremely poor quality of life and no satisfaction. Lower scores indicate better perceived quality of life.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days

• Change in Sleep and Well-Being Complaints Questionnaire Responses

  Change from baseline in participant-reported sleep and well-being complaints. The questionnaire assesses sleep initiation and latency, sleep maintenance and quality, morning refreshment and energy, daytime functioning and cognitive clarity, and emotional and physical well-being. Individual complaints are assessed as present or absent, with severity rated from 0 to 100 when a complaint is endorsed.

  Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 28 days

• Participant Experience With the Study Product

  Participant responses to the Product Experience Questionnaire assessing overall satisfaction with the study product, ease of use, perceived effects on sleep and daytime functioning, overall product experience, and willingness to recommend or continue using the product. Scored Likert items range from 1 (Strongly Disagree) to 4 (Strongly Agree), with higher scores indicating a more favorable product experience. Selected items include 0 = Not Applicable, which is not treated as a scored response. Additional items use Yes/No/Not Applicable or open-text responses. No composite total score is calculated; responses are summarized by individual item.

  Week 12 (Day 85 ± 3 days) and Week 16 (Day 113 ± 3 days)

• Participant-Reported Changes Following Study Product Discontinuation

  Participant responses to the Washout Questionnaire assessing perceived changes following discontinuation of the study product, including sleep quality, daytime restfulness and energy, cognitive function, mood, overall satisfaction, perceived product benefit, and likelihood of recommending the product. The questionnaire uses item-specific ordered categorical response options, including 4-level responses (e.g., Very Dissatisfied to Very Satisfied; Strongly Disagree to Strongly Agree) and 5-level responses (e.g., Not Effective to Very Effective; Much Worse to Much Better; Definitely Not to Definitely Yes). More favorable response categories indicate a more favorable perceived outcome. No composite total score or single minimum/maximum questionnaire score is calculated; responses are summarized by individual item.

  Week 16 (Day 113 ±3 days), following approximately 4 weeks of study product discontinuation

Study Arms (1)

Bonafide Sleep

EXPERIMENTAL

Participants received Bonafide Sleep orally as two tablets once daily approximately 60 minutes before bedtime from Day 1 through Day 85. After the intervention period, participants discontinued the study product and entered a washout period through Day 113.

Dietary Supplement: S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate

Interventions

S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate DIETARY_SUPPLEMENT

A daily dietary sleep supplement taken once per day for 85 days.

Also known as: Bonafide Sleep

Bonafide Sleep

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy women who are 40 to 65 years of age (inclusive).
• Have a body mass index (BMI) between 18.5 to 39.9 kg/m2 (inclusive).
• Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) T-Score Cut Point ≥ 55 (equivalent to a raw score of 25).
• Women enrolled in this research study may be of perimenopausal, (12 or more months without a menstrual period) or post-menopausal status. Post-menopause defined as the last natural menstrual period (LNMP) completed at least 12 months prior to screening. Perimenopause defined as women who complained of irregular menstrual cycle in the past 12 months, with a forward or postponed cycle more than 7 days. At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days.
• In good general health (no uncontrolled diseases or conditions) and able to consume the study product.
• Agree to refrain from treatments listed in Section 12.4 in the defined timeframe.
• Has stable access to Wi-Fi and an iPhone or Android device.
• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

You may not qualify if:

• Individuals who are lactating, pregnant, or planning to become pregnant during the study.
• Perimenopausal women who are sexually active will be required to specify contraceptive method or be excluded.
• Currently incarcerated prisoners.
• Currently enrolled in a different clinical trial.
• Use of any treatment for sleep symptoms or other concomitant treatments listed in Section 12.4.
• Participants whose insomnia is predominantly attributed to significant medical, psychiatric, or environmental factors (e.g., restless leg syndrome, sleep apnea, chronic pain, anxiety, depression, or shift work) may be excluded, at the discretion of the investigator, if it is determined that these factors could interfere with study outcomes or participant safety.
• Have a known sensitivity, intolerability, or allergy to the study product or their excipients.
• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study or influence the results or the potential subject's ability to participate in the study.
• Major surgery in one month prior to screening or planned major surgery during the study.
• Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant. Note: screened participants with infections would be eligible to participate four weeks after completing their treatment (wash-out period).

Sponsors & Collaborators

• Bonafide Health: lead

Study Sites (1)

Bonafide Health, LLC

Harrison, New York, 10528, United States

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence

Interventions

S-Adenosylmethionine; Propyl Gallate; gamma-Aminobutyric Acid; theanine; magnesium diglycinate

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Gallic Acid; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Aminobutyrates; Butyrates; Acids, Acyclic

Study Officials

• Trisha VanDusseldorp, PhD

  Bonafide Health, LLC

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single-group, open-label study in which all participants received the investigational dietary sleep supplement during the intervention period, followed by a post-intervention washout period.

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 24, 2026
• Study Start: January 3, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)