Ganmaidazao Concentrated Beverage Sleep-Assisting Trial

The Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported questionnaire evaluating sleep quality over the past month, covering 7 domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each domain is scored 0-3, with a total score ranging from 0 to 21; higher scores indicate worse sleep quality. The total PSQI score will be assessed to evaluate changes in participants' sleep status.

The Fatigue Scale-14 (FS-14) is a validated self-reported questionnaire developed to assess the severity of subjective fatigue over the past week. It contains 14 binary yes/no items divided into two subscales: 8 items for physical fatigue and 6 items for mental fatigue. Each item is scored 0 (no) or 1 (yes), with a total score ranging from 0 to 14. Higher total scores indicate more severe physical and mental fatigue. The FS-14 total score will be measured to evaluate changes in participants' fatigue status throughout the trial.

The Spiegel Sleep Questionnaire is a validated self-reported scale for evaluating subjective insomnia and sleep status. It contains 6 domains: sleep onset latency, total sleep duration, frequency of nocturnal awakenings, sleep depth, nighttime dream frequency, and morning refreshment feeling. Each item is scored on a 5-level scale of 0, 1, 3, 5, 7 points; the total score ranges from 0 to 42. Higher total scores indicate more severe sleep disturbance. A total score ≥12 suggests clinically meaningful insomnia. The total Spiegel score will be assessed to evaluate the improvement of participants' sleep conditions throughout the trial.

Objective total sleep time (unit: minutes) captured daily by wearable sleep monitoring bracelet from Day 0 to Day 28. The change relative to baseline (Day 0) will be analyzed and reported.

Salivary melatonin is measured to assess circadian rhythm function, with samples collected at 3 time points within 2 hours before bedtime on D0/D1 (pre-intervention) and D27/D28 (post-intervention). Melatonin AUCg and slope will be calculated to analyze secretion changes after 28-day intervention.

Salivary cortisol is tested to assess the cortisol awakening response (CAR) and HPA axis activity, which reflects stress status related to sleep disturbance. Saliva samples are collected on pre-intervention Day 0, Day 1 and post-intervention Day 27, Day 28. On each collection morning, four sequential samples are obtained immediately after waking (T0), 15 min (T1), 30 min (T2) and 45 min (T3) after awakening while participants stay supine. Derived parameters including total cortisol awakening AUCg, incremental AUCi, awakening slope and maximum concentration change (Δmax) are calculated to compare HPA axis reactivity before and after the 28-day functional food intervention. All sampling operations follow standardized saliva collection specifications to avoid confounding factors such as food, exercise and oral care products.

Objective sleep efficiency (unit: percentage, %) captured daily by wearable sleep monitoring bracelet from Day 0 to Day 28. The change relative to baseline (Day 0) will be analyzed and reported.

Objective deep sleep duration (unit: minutes) captured daily by wearable sleep monitoring bracelet from Day 0 to Day 28. The change relative to baseline (Day 0) will be analyzed and reported.

Objective sleep onset latency (unit: minutes) captured daily by wearable sleep monitoring bracelet from Day 0 to Day 28. The change relative to baseline (Day 0) will be analyzed and reported.

Participants fill out sleep diaries every day during the 28-day intervention to record actual bedtime. Data collected daily from Day 0 to Day 28 will be analyzed, and the change relative to baseline (Day 0) will be reported.

Participants fill out sleep diaries every day during the 28-day intervention to record wake-up time. Data collected daily from Day 0 to Day 28 will be analyzed, and the change relative to baseline (Day 0) will be reported.

Subjects self-rate daily perceived sleep quality in sleep diaries throughout Day 0 to Day 28. Changes versus baseline (Day 0) will be summarized and reported.

Participants record the daily count of nighttime awakenings in sleep diaries from Day 0 to Day 28. Changes relative to baseline will be reported.

Subjects document any sleep-related discomfort each day in sleep diaries over the 28-day intervention period. The frequency of discomfort will be summarized and reported.