Bonafide Sleep Supplement for Menopausal Women With Impaired Sleep

NCT07839299 | Completed

• 1 other identifier: Pro00083186
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This open-label study evaluated whether a daily dietary sleep supplement could improve sleep and related daytime functioning in menopausal women aged 40 to 65 with impaired sleep. Participants used the supplement for approximately 12 weeks, followed by a four-week period without the supplement to evaluate changes after discontinuation. Sleep, daytime functioning, product experience, safety, and tolerability were assessed throughout the study.

Conditions

Sleep Disturbances

Keywords

Menopause; Perimenopause; Postmenopause; Sleep Disturbance; Sleep Quality; Sleep Onset Latency; Wake After Sleep Onset; Nighttime Awakenings; Daytime Functioning; Cognitive Function; Women's Health

Outcome Measures

Primary Outcomes (3)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form T-Score

  Change from baseline in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) T-score. The PROMIS SD SF assesses self-reported perceptions of sleep, including difficulty getting to or staying asleep, sleep satisfaction, and overall sleep quality over the prior seven days.

  Baseline (Day 1) through Day 113 (±3 days)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function Short Form T-Score

  Change from baseline in the Patient-Reported Outcomes Measurement Information System Cognitive Function Short Form (PROMIS CF SF) T-score. The PROMIS CF SF assesses perceived cognitive abilities in everyday activities, including memory, attention, and mental clarity.

  Baseline (Day 1) through Day 113 (±3 days)

• Change in Pittsburgh Sleep Quality Index (PSQI) Score

  Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score. The PSQI is a validated patient-reported instrument assessing sleep quality and disturbances over a one-month period, including sleep duration, sleep latency, habitual sleep efficiency, sleep disturbances, and overall subjective sleep quality.

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

Secondary Outcomes (14)

• Change in Total Sleep Time (TST)

  Day -7 (run-in baseline) through Day 113 (±3 days)

• Change in Sleep Disturbances

  Day -7 (run-in baseline) through Day 113 (±3 days)

• Change in Wake After Sleep Onset (WASO)

  Day -7 (run-in baseline) through Day 113 (±3 days)

• Change in Sleep-Onset Latency (SOL)

  Day -7 (run-in baseline) through Day 113 (±3 days)

• Change in Daytime Sleepiness

  Day -7 (run-in baseline) through Day 113 (±3 days)

Other Outcomes (4)

• Change in Total Wake Time (TWT)

  Day -7 (run-in baseline) through Day 113 (±3 days)

• Change in Sleep Efficiency (SE)

  Day -7 (run-in baseline) through Day 113 (±3 days)

• Change in Self-Reported Cognitive Function From Daily Sleep Diaries

  Day -7 (run-in baseline) through Day 113 (±3 days)

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 34.9 kg/m2 (inclusive).
• Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) T-Score Cut Point ≥ 60 (equivalent to a raw score of 30).
• 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 active or 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.
• Previous use of SAMe, PG, GABA, Theanine, and/or Magnesium (unless in a multivitamin) within 3 months prior to screening.
• Use of any treatment for sleep symptoms or other concomitant treatments listed in Section 12.4.
• Taking blood thinners within the last 2 weeks. Further details may be found in Section 12.4.
• Have a known sensitivity, intolerability, or allergy to the study product or their excipients.
• Received a vaccine for COVID-19 in the two weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post-COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis).
• Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (e.g., Lyme disease, TB, HIV).
• History of cancer (except localized skin cancer without metastases) within two (2) years prior to screening.
• 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.
• History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
• Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
• Major surgery in three months prior to screening or planned major surgery during the study.

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

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: August 23, 2025
• Study Completion: August 23, 2025
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)