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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
25
Haelan 951 is a fermented soy product administered orally once daily for 30 days. Participants will consume the study product according to the protocol to evaluate its effects on self-reported menopausal vasomotor symptoms, sleep quality, and health-related quality of life in peri- and postmenopausal women.
Spectrum Clinical Research
Kansas City, Missouri, United States
RECRUITINGVasomotor Symptom Episode
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.
Time frame: Baseline to Day 30
Sleep
Change from Baseline to Day 30 in self-reported sleep, captured daily by the H951 Sleep Assessment (bedtime, sleep latency, wake time, number of awakenings, awakenings attributed to hot flashes or night sweats,
Time frame: Baseline to Day 30
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