A Study of a Sleep Supplement to Improve Sleep in Women Going Through Menopause

NCT07375095 | Completed

• 1 other identifier: Pro00073864
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated whether a daily dietary sleep supplement could improve sleep in women aged 40 to 65 who experience moderate sleep disturbances during menopause. Participants were randomly assigned to take either the supplement or a placebo for about three weeks. All study visits were conducted virtually. Sleep was assessed through daily diaries and weekly questionnaires measuring sleep quality, nighttime awakenings, daytime alertness, and mood. The study's goal was to compare changes between the supplement and placebo groups and to assess safety and tolerability during the study period.

Conditions

Sleep Disturbance

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b T-score

  Change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b T-score, a validated patient-reported outcome measure assessing perceived sleep quality, difficulty falling or staying asleep, and overall sleep satisfaction over the prior 7 days. The PROMIS Sleep Disturbance Short Form 8b yields raw scores ranging from 8 to 40, which are converted to standardized T-scores ranging from 28.9 to 76.5. Higher T-scores indicate greater sleep disturbance (worse sleep outcomes).

  Day -7 (run-in baseline) to Day 21 (±3 days)

• Responder Rate for Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b

  Responder rate defined as the proportion of participants achieving a clinically meaningful improvement in sleep disturbance, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b T-score. The PROMIS Sleep Disturbance Short Form 8b yields raw scores ranging from 8 to 40, corresponding to standardized T-scores ranging from 28.9 to 76.5, with higher scores indicating greater sleep disturbance (worse sleep outcomes). Responders were defined as participants who experienced a decrease of ≥8 points in the PROMIS Sleep Disturbance T-score from baseline, consistent with the established minimal clinically important difference (MCID) for this measure.

  Day -7 (run-in baseline) to Day 21 (±3 days)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a T-score

  Change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a T-score, a validated patient-reported outcome measure assessing daytime alertness, sleepiness, fatigue, and functional impairment related to sleep over the prior 7 days. The PROMIS Sleep-Related Impairment Short Form 8a yields raw scores ranging from 8 to 40, which are converted to standardized T-scores ranging from 30.0 to 80.1. Higher T-scores indicate greater sleep-related impairment (worse daytime functioning).

  Day -7 (run-in baseline) to Day 21 (±3 days)

• Responder Rate for Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a

  Responder rate defined as the proportion of participants achieving a clinically meaningful improvement in sleep-related impairment, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a T-score. The PROMIS Sleep-Related Impairment Short Form 8a yields raw scores ranging from 8 to 40, corresponding to standardized T-scores ranging from 30.0 to 80.1, with higher scores indicating greater sleep-related impairment (worse daytime functioning). Responders were defined as participants who experienced a decrease of ≥6.5 points in the PROMIS Sleep-Related Impairment T-score from baseline, based on the 95% reliable change index (RCI), representing a magnitude of change exceeding measurement error and consistent with clinically meaningful improvement in similarly aged adults with sleep-related impairment.

  Day -7 (run-in baseline) to Day 21 (±3 days)

Secondary Outcomes (9)

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

  Day -7 (run-in baseline) to Day 21 (±3 days)

• Change in Total Sleep Time (TST)

  Day -7 (run-in baseline) to Day 21 (±3 days)

• Change in Sleep Efficiency

  Day -7 (run-in baseline) to Day 21 (±3 days)

• Change in Sleep-Onset Latency (SOL)

  Day -7 to Day 21 (±3 days)

• Change in Difficulty Falling Asleep as Measured by a Visual Analog Scale (VAS)

  Day -7 (run-in baseline) to Day 21 (±3 days)

Study Arms (2)

Dietary Supplement Arm

EXPERIMENTAL

Participants received the dietary sleep supplement once daily for 21 days. The product was taken 60 minutes before bedtime during the intervention period. All dosing and study activities were conducted virtually.

Dietary Supplement: Sleep Supplement

Placebo Arm

PLACEBO COMPARATOR

Participants received a placebo matched in appearance and dosing schedule to the supplement. The placebo was taken once daily, 60 minutes before bedtime, for 21 days. All dosing and study activities were conducted virtually.

Drug: Placebo

Interventions

Sleep Supplement DIETARY_SUPPLEMENT

A daily dietary sleep supplement taken once per day for 21 days.

Dietary Supplement Arm

Placebo DRUG

A placebo matched in appearance and dosing schedule to the sleep supplement, taken once per day for 21 days.

Placebo Arm

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).
• 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.
• i. 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 SAM-e, 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 any of the study products 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

Condition Hierarchy (Ancestors)

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

Study Officials

• Trisha VanDusseldorp, PhD

  Bonafide Health, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study used a double-blind design in which participants, investigators, care providers, and outcomes assessors were unaware of group assignment. The supplement and placebo were matched in appearance, packaging, and administration instructions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A two-arm, randomized, double-blind, placebo-controlled parallel assignment in which participants were allocated to either the dietary supplement or placebo group and remained in the same group for the duration of the 21-day intervention. All study procedures were conducted virtually.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 29, 2026
• Study Start: October 10, 2023
• Primary Completion: April 7, 2024
• Study Completion: April 7, 2024
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)