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.
Provide voluntary, written, informed consent to participate in the study
Agree to provide a valid cell phone number and are willing to receive communications through text
Can read and write English
Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly
Women who are pregnant, breastfeeding, or planning to become pregnant or start breastfeeding during the trial
Known food intolerances/allergy to any ingredients in the product
Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer
Having had a significant cardiovascular event in the past 6 months
Parallel
Qualia Perimenopause Formula A
Dietary supplementQualia Perimenopause is a multi-botanical natural health product/dietary supplement formulated to support women during the perimenopausal transition. The formulation is intended to address common domains of symptom burden-including vasomotor, psychological, cognitive, and sleep-related complaints-through complementary mechanisms of action. Participants receive one capsule once daily for 28 consecutive days. Three different formulations are being tested in this trial (Formula A, Formula B, and Formula C).
Qualia Perimenopause Formula B
Dietary supplementQualia Perimenopause is a multi-botanical natural health product/dietary supplement formulated to support women during the perimenopausal transition. The formulation is intended to address common domains of symptom burden-including vasomotor, psychological, cognitive, and sleep-related complaints-through complementary mechanisms of action. Participants receive one capsule once daily for 28 consecutive days. Three different formulations are being tested in this trial (Formula A, Formula B, and Formula C).
Qualia Perimenopause Formula C
Dietary supplementQualia Perimenopause is a multi-botanical natural health product/dietary supplement formulated to support women during the perimenopausal transition. The formulation is intended to address common domains of symptom burden-including vasomotor, psychological, cognitive, and sleep-related complaints-through complementary mechanisms of action. Participants receive one capsule once daily for 28 consecutive days. Three different formulations are being tested in this trial (Formula A, Formula B, and Formula C).
Menopause Rating Scale (MRS) - Total Score
Between-group change from baseline to Day 28 in menopause symptoms measured by the total Menopause Rating Scale (MRS) score. The MRS is an 11-item self-rating scale that measures the severity of menopausal symptoms with a total score range of 0-44.
PROMIS Cognitive Function v2.0 - Short Form 8a
Within- and between-group changes from baseline to Days 14 and 28 in cognitive function measured by PROMIS Cognitive Function v2.0 - Short Form 8a, an 8-item assessment of perceived cognitive abilities including mental acuity, concentration, and memory.
Safety and Tolerability Survey
Within- and between-group changes from baseline to Days 14 and 28 in side effect profile using a custom Safety and Tolerability survey assessing symptoms including nausea, headache, mood changes, dizziness, bloating, itching, and sexual dysfunction.
PROMIS Sleep Disturbance - Short Form
Within- and between-group changes from baseline to Days 14 and 28 in sleep measured by PROMIS Sleep Disturbance - Short Form, an 8-item assessment of sleep quality, restfulness, and disturbance severity.
MRS Psychological Subdomain
Within- and between-group changes from baseline to Days 14 and 28 in the Psychological subdomain of the Menopause Rating Scale (items 4-7: depressive mood, irritability, anxiety, exhaustion).
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