A Decentralized, Site-Anchored Hybrid, Open-Label, Single-Arm Proof-of-Concept Study Evaluating the Effect of Haelan 951 - a Fermented Soy Conventional Food Product - on Self-Reported Menopausal Vasomotor and Sleep-Related Outcomes in Post- and Peri-Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Vasomotor Symptom Episode
研究概览
简要总结
This proof-of-concept, open-label, single-arm study is designed to evaluate the effects of daily consumption of Haelan 951, a fermented soy conventional food product, on self-reported menopausal vasomotor symptoms, sleep quality, and health-related quality of life in peri- and postmenopausal women. The study will collect descriptive data on participant-reported outcomes over the study period to assess the feasibility and potential effects of Haelan 951 in supporting menopausal wellness. The study is not intended to evaluate the treatment, prevention, or cure of any disease.
详细描述
This is a decentralized, site-anchored hybrid, open-label, single-arm proof-of-concept study designed to evaluate the effects of daily consumption of Haelan 951, a fermented soy conventional food product, on self-reported menopausal vasomotor symptoms, sleep quality, and health-related quality of life in peri- and postmenopausal women.
Approximately 25 eligible participants will be enrolled and followed over a 30-day treatment period. Following informed consent and screening at the clinical research site, eligible participants will receive Haelan 951 along with study-specific training, wearable device setup, and electronic patient-reported outcome (ePRO) instructions. Subsequent study activities will primarily occur remotely using decentralized clinical trial methods, including electronic diaries, validated questionnaires, wearable technology, scheduled telehealth contacts, and virtual follow-up assessments.
The primary objective is to generate descriptive scientific evidence regarding changes in participant-reported vasomotor symptoms following daily consumption of Haelan 951. Secondary objectives include evaluating participant-reported sleep quality, menopause-related quality of life, treatment satisfaction, adherence, and overall feasibility of conducting a decentralized hybrid clinical study utilizing remote data collection technologies.
Study endpoints consist primarily of validated participant-reported outcome measures and continuously collected physiologic data obtained through study-provided wearable devices. Data collected during the study will be used to characterize changes over time and to estimate effect sizes for future controlled clinical investigations.
Haelan 951 is being evaluated as a fermented soy conventional food product intended to support general wellness in peri- and postmenopausal women. This proof-of-concept study is exploratory in nature and is not designed to establish efficacy for the treatment, cure, mitigation, or prevention of disease. Any future commercial communication based on study findings will be limited to permissible structure/function statements and will comply with applicable U.S. Food and Drug Administration regulations governing conventional food products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex assigned at birth, ages 45-65 years inclusive at the time of consent.
- •Post-menopausal (≥12 consecutive months amenorrhea, STRAW+10 stage +1) OR peri-menopausal (STRAW+10 stages -2 or -1) at consent. PI to confirm staging at Screening.
- •Self-reported vasomotor symptoms ≥3 months' duration prior to Screening, averaging ≥4 episodes per 24-hour period over the 7 days prior to Screening.
- •Willing and able to consume the investigational product as directed (30 mL twice daily, empty stomach, 30 days).
- •Willing and able to complete daily eCOA entries in the study application and to wear the study wearable throughout the Treatment period.
- •Possession of (or willingness to use) a personal smartphone running iOS 16+ or Android 12+, with reliable daily internet access.
- •Resident of the Kansas City metropolitan area [30- 45 mile radius] and able to travel to Spectrum Clinical Research for a single onsite Participant Onboarding Visit.
- •Able to read, understand, and provide written informed consent in English at approximately an 8th-grade reading level.
- •Willing to abstain from initiation of any new HRT, menopause-related supplement, or other menopause-related therapeutic intervention for the study duration.
排除标准
- •Pre-menopausal status (STRAW+10 stage -3 or earlier).
- •Current pregnancy, planning pregnancy during the study, or breastfeeding.
- •Current use of any systemic or topical HRT. Required wash-out prior to Day 1: 30 days systemic and 30 days topical/local, aligned with the Screening period and the 30-day study duration; the PI may extend for an individual on documented clinical rationale per ICH E6(R3) 4.2.
- •Current use of any menopause-related dietary supplement within 30 days prior to Day 1, unless on a stable regimen ≥3 months and willing to maintain it unchanged (documented in medical history).
- •Known soy allergy or hypersensitivity to any component of Haelan 951 (Purified Water, Organic Cultured Soy Powder, Yeast, Salt).
- •History of estrogen- or progesterone-receptor-positive breast cancer; active malignancy of any type; or current systemic chemotherapy, immunotherapy, or radiation therapy.
- •Heavy alcohol use (≥3 alcoholic beverages/day on average, per NIAAA definitions).
- •Major surgical procedure or hospitalization within 90 days prior to Screening, or any unresolved condition that the PI judges would compromise safety or interpretation of endpoints.
- •Documented uncontrolled or unstable medical condition (e.g., uncontrolled cardiovascular disease; CKD stage 3b or worse; moderate-to-severe hepatic impairment; active autoimmune disease on systemic immunosuppression), established from medical history and PI clinical assessment.
- •Current use of medications with documented potential for clinically significant interaction with soy-derived foods (thyroid replacement unless dose-stable ≥6 weeks with 4-hour separation; oral anticoagulants on non-stable dose; MAOIs; tamoxifen or other hormone-modulating cancer therapies).
- •Current or recent (within 30 days) participation in another interventional clinical study.
- •Inability to provide informed consent (cognitive impairment, language barrier - materials are English-only - or other reason per PI judgment).
- •Other reasons judged by the PI, with documented rationale per ICH E6(R3) 4.2.1, to compromise safety, well-being, or scientific validity.
研究组 & 干预措施
Haelan 951
Participants will receive Haelan 951, a fermented soy conventional food product, for 30 consecutive days. Following an in-person screening and baseline visit, participants will complete the study using a decentralized, site-anchored hybrid model with electronic patient-reported outcome (ePRO) assessments, wearable device monitoring, and scheduled remote follow-up.
干预措施: Haelan 951 (Dietary Supplement)
结局指标
主要结局
Vasomotor Symptom Episode
时间窗: Baseline to Day 30
Change from Baseline to Day 30 in the daily frequency of moderate-to-severe vasomotor symptom episodes, captured by the H951 Daily Vasomotor Symptom Diary.
次要结局
- Sleep(Baseline to Day 30)