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

Обзор

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.

Подробное описание

Perimenopause is a transitional phase preceding menopause characterized by fluctuating ovarian hormone levels and variable cycle length, often accompanied by a constellation of symptoms spanning vasomotor disturbances, sleep disruption, cognitive and attentional changes, mood lability, somatic complaints, and urogenital discomfort. These symptoms can meaningfully impair quality of life, productivity, interpersonal functioning, and health-related well-being. Although menopausal hormone therapy is an established option for selected individuals, many women either do not elect or are not candidates for hormone-based interventions and seek nonhormonal approaches that address multiple symptom domains concurrently. In this context, multi-ingredient botanical formulations are of growing interest as supportive strategies designed to target the diverse and interrelated pathways implicated in perimenopausal symptomatology.

Qualia 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.

Study Design: This is an open-label, three-arm, parallel-group trial with stratified randomization by baseline Menopause Rating Scale (MRS) total score. Participants will be stratified and randomly assigned to one of three study arms in a 1:1:1 ratio. Study duration is 28 days of supplementation.

Participants will take one capsule once daily of their assigned formula for 28 consecutive days. All data are self-reported; assessments are completed electronically at home at baseline, mid-intervention (day 14), and end-of-study (day 28), with a brief follow-up questionnaire. Approximately 120 healthy female participants ages 40-55 with menopause symptoms but not yet in menopause (period within last 12 months) and MRS total score ≥ 5 will be enrolled.

Вмешательства

• Пищевая добавка Qualia Perimenopause Formula A
  Qualia 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 Fo
• Пищевая добавка Qualia Perimenopause Formula B
  Qualia 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 Fo
• Пищевая добавка Qualia Perimenopause Formula C
  Qualia 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 Fo

Первичные конечные точки

• Menopause Rating Scale (MRS) - Total Score [Срок оценки: Day 28]

Вторичные конечные точки (7)

• PROMIS Cognitive Function v2.0 - Short Form 8a [Срок оценки: Day 14, Day 28]
• Safety and Tolerability Survey [Срок оценки: Day 14, Day 28]
• PROMIS Sleep Disturbance - Short Form [Срок оценки: Day 14, Day 28]
• MRS Psychological Subdomain [Срок оценки: Day 14, Day 28]
• MRS Somato-Vegetative Subdomain [Срок оценки: Day 14, Day 28]
• MRS Urogenital Subdomain [Срок оценки: Day 14, Day 28]
• Follow-up Questionnaire [Срок оценки: Day 33 (5-7 days after final dose)]

Критерии участия

Критерии включения

• 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
• Willing to complete questionnaires, records, and diaries associated with the study
• Healthy female participants ages 40-55 with menopause symptoms but not yet in menopause (period within last 12 months)
• MRS total score ≥ 5 (preference given to higher score)

Критерии исключения

• 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
• Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines
• On immunosuppressive therapy
• Having had surgery within the past 6 weeks or upcoming planned surgery in the next few months
• Adults lacking capacity to consent
• Post-menopause (≥12 consecutive months without a period)
• Taking medications: hormone replacement therapy; oral contraceptives; selective estrogen receptor modulators/aromatase inhibitors (e.g., Tamoxifen); sedatives/anxiolytics; blood thinners; insulin

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

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Центры проведения

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Идентификаторы

NCT: NCT07361757 · QLS-022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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