Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07375095
Eligibility Criteria:
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).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT07375095
Study Brief:
Protocol Section:
NCT07375095