Qualia Perimenopause Efficacy and Tolerability Study: An Open-label 3-Arm Trial

This is an open-label, 3-arm clinical trial evaluating the short-term efficacy and tolerability of Qualia Perimenopause-a multi-ingredient dietary supplement formulated to support perimenopausal symptoms-in healthy women aged 40-55 who are symptomatic but not yet menopausal (menses within the past 12 months). Approximately 120 participants will be allocated across three parallel arms and will take 1 capsule once daily for 28 consecutive days. The primary outcome is between-group change from baseline to day 28 in menopause symptom burden measured by the total Menopause Rating Scale (MRS). Secondary outcomes include within- and between-group changes at days 14 and 28 in cognitive function (PROMIS Cognitive Function v2.0 - Short Form 8a), sleep disturbance (PROMIS), MRS subdomains (psychological, somato-vegetative, urogenital), overall MRS change, safety/tolerability (custom survey), and participant-reported product experience. All assessments are completed electronically at home at baseline, mid-intervention (day 14), and end-of-study (day 28), with a brief follow-up questionnaire; there are no in-person visits.

Inclusion criteria: 1. Provide voluntary, written, informed consent to participate in the study 2. Agree to provide a valid cell phone number and are willing to receive communications through text 3. Can read and write English 4. Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly 5. Willing to complete questionnaires, records, and diaries associated with the study 6. Healthy female participants ages 40-55 with menopause symptoms but not yet in menopause (period within last 12 months) 7. MRS total score ≥ 5 (preference given to higher score) Exclusion criteria: 1. Women who are pregnant, breastfeeding, or planning to become pregnant or start breastfeeding during the trial 2. Known food intolerances/allergy to any ingredients in the product 3. Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer 4. Having had a significant cardiovascular event in the past 6 months 5. Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines 6. On immunosuppressive therapy 7. Having had surgery within the past 6 weeks or upcoming planned surgery in the next few months 8. Adults lacking capacity to consent 9. Post-menopause (≥12 consecutive months without a period) 10. Taking medications: hormone replacement therapy; oral contraceptives; selective estrogen receptor modulators/aromatase inhibitors (e.g., Tamoxifen); sedatives/anxiolytics; blood thinners; insulin