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

Effect of BH-SLP-001 Sleep Supplement on Sleep Parameters in Menopausal Women: A Randomized, Double-Blind, Placebo-Controlled Trial

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.

This study was a randomized, double-blind, placebo-controlled, parallel-group clinical trial conducted to evaluate the effects of a dietary sleep supplement on subjective sleep disturbance, sleep-related impairment, and related sleep parameters in perimenopausal and postmenopausal women with moderate sleep complaints.

Participants were enrolled remotely and randomized in a 1:1 ratio to receive either the investigational dietary supplement or a matching placebo. Randomization was performed using a blinded allocation scheme, and blinding was maintained for participants and all study personnel involved in participant management, data collection, and outcome assessment. Study products were physically and visuallyishable to preserve masking throughout the study.

Following electronic informed consent, participants completed a screening phase conducted via virtual visit, during which baseline sleep disturbance and medical history were assessed to confirm eligibility. Eligible participants then entered a run-in period of approximately seven days, during which they completed daily electronic sleep diaries to establish baseline sleep patterns and to familiarize themselves with study procedures. No study product was consumed during the run-in period.

After completion of the run-in phase, participants initiated the intervention period (Day 1) and self-administered the assigned study product once daily for 21 ± 3 days. The investigational product was administered orally approximately 60 minutes before bedtime, and participants randomized to placebo followed an identical dosing schedule.

Throughout the intervention period, participants completed daily electronic sleep diaries and periodic electronic questionnaires assessing changes in sleep disturbance, sleep-related impairment, overall sleep quality, and daytime functioning. Assessments were collected at baseline and at regular intervals during the dosing period, consistent with the protocol-defined schedule of activities. At the end-of-study visit, participants completed a product experience questionnaire evaluating usability and overall experience with the study product.

All study visits and assessments were conducted remotely. Safety and tolerability were monitored throughout the study through participant self-report and scheduled virtual check-ins. Adverse events were collected, assessed for severity and relatedness, and followed through resolution in accordance with protocol-defined safety monitoring procedures.

Each participant's total duration of participation was approximately four to five weeks, including screening, run-in, intervention, and end-of-study assessments. The study was designed to characterize the short-term effects, safety, and tolerability of a dietary sleep supplement in menopausal women experiencing moderate sleep disturbance under fully remote study conditions.

Inclusion Criteria:

1. Healthy women who are 40 to 65 years of age (inclusive).

2. Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).

3. PROMIS SD SF T-Score Cut Point ≥ 60 (equivalent to a raw score of 30).

4. Women enrolled in this research study may be of perimenopausal, (12 or more months without a menstrual period) or post-menopausal status.

   1. Post-menopause defined as the last natural menstrual period (LNMP) completed at least 12 months prior to screening.
   2. 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.

5. In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.

6. Agree to refrain from treatments listed in Section 12.4 in the defined timeframe.

7. Has stable access to Wi-Fi and an iPhone or Android device.

8. 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.

Exclusion Criteria:

1. Individuals who are lactating, pregnant, or planning to become pregnant during the study.
2. Perimenopausal women who are sexually active will be required to specify contraceptive method or be excluded.
3. Currently incarcerated prisoners.
4. Currently enrolled in a different clinical trial.
5. Previous use of SAM-e, PG, GABA, Theanine, and/or Magnesium (unless in a multivitamin) within 3 months prior to screening.
6. Use of any treatment for sleep symptoms or other concomitant treatments listed in Section 12.4.
7. Taking blood thinners within the last 2 weeks. Further details may be found in Section 12.4.
8. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
9. 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).
10. Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (e.g., Lyme disease, TB, HIV).
11. History of cancer (except localized skin cancer without metastases) within two (2) years prior to screening.
12. 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.
13. 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).
14. 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).
15. Major surgery in three months prior to screening or planned major surgery during the study.
16. Currently diagnosed with depression by a doctor or physician.
17. Have been or currently diagnosed with bipolar disorder by a doctor or physician.
18. History of epilepsy or taking epileptic medications.
19. Presence of sleep disorders that have been diagnosed by a doctor or physician.
20. Currently using any sleep device (e.g., nebulizer machine, sleep apnea masks, continuous positive airway pressure (CPAP)) to improve sleep.
21. Recent shift work, night work, or frequent travel to different time zones in the past month, which, in the opinion of the investigator, may adversely affect the participant's sleep quality.
22. Consumption of more than 400 mg of caffeine per day.
23. History of alcohol or substance abuse in the last 5 years.
24. Report ≥ 5 night sweats per week.
25. Report ≥20 hot flashes per week.
26. Have animals that frequently cause sleep disturbances
27. Have partners who regularly disturb their sleep
28. Have young children or infants who frequently require caregiving responsibilities and disturb sleep
29. Planned travel during the study period that, in the opinion of the investigator, may negatively influence the participant's sleep.
30. 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).