Certain classical formulas in traditional Chinese medicine and dietary prebiotics have demonstrated beneficial effects on various aspects of suboptimal health status in previous studies. This research aims to evaluate the effects of Bao Yuan Tang full-component extract combined with galactooligosaccharides on improving health-related outcomes in female registered nurse with suboptimal health status, including sleep disturbances, fatigue, endocrine dysregulation, and glucose and lipid metabolic abnormalities.
Female registered nurses aged 25-45 years.
Participants must meet at least one of the following criteria, self-reported presence of at least one target symptom of the trial, including insomnia, daytime fatigue, or difficulty initiating sleep or Pittsburgh Sleep Quality Index (PSQI) score >7.
Engagement in shift work for at least one month before enrollment, with either ≥ 4 night shifts or ≥32 hours of night-shift work during the preceding month.
Diagnosed with type 1 or type 2 diabetes mellitus and currently receiving pharmacological treatment.
Diagnosed with clinically thyroid dysfunction, including hyperthyroidism or hypothyroidism, and currently receiving pharmacological treatment.
Diagnosed with Cushing's syndrome, pituitary dysfunction, or other clearly defined endocrine disorders.
Diagnosed with polycystic ovary syndrome (PCOS) and currently receiving pharmacological treatment.
Parallel
Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g)
Dietary supplementParticipants will receive a combination product consisting of Bao Yuan Tang full-component extract (2.0g) and galactooligosaccharides (2.0g). The intervention will be administered twice daily, one sachet each time, for 3 weeks.
Bao Yuan Tang full-component extract 2.0g plus a placebo consisting of maltodextrin 2.0g
Dietary supplementParticipants will receive Bao Yuan Tang full-component extract (2.0g) plus a placebo consisting of maltodextrin (2.0g). The intervention will be administered twice daily, one sachet each time, for 3 weeks.
Galactooligosaccharides 2.0g
Dietary supplementParticipants will receive galactooligosaccharides (2.0g) combined with a maltodextrin placebo (2.0g). The intervention will be administered twice daily, one sachet each time, for 3 weeks.
maltodextrin placebo 4.0g
Other interventionParticipants will receive maltodextrin placebo (4.0g), administered twice daily, one sachet each time, for 3 weeks.
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed the original standard PSQI. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The data will be collected daily from baseline (Day 0) to the end (Day 30).
Serum cortisol
Blood samples will be collected at the day of enrollment and 10 and 21 days thereafter to assess changes in serum cortisol levels, the normal reference range is 140-630 nmol/L.
Serum total cholesterol and triglyceride
Blood samples will be collected at the day of enrollment and 10 and 21 days thereafter to measure serum total cholesterol and triglyceride levels, the normal reference levels are \<5.2 mmol/L for total cholesterol and \<1.7 mmol/L for triglycerides.
Changes in sleep efficiency
Sleep efficiency is calculated as total sleep time divided by time spent in bed × 100%, with ≥85% generally considered normal. The change from baseline (Day 0) to the end of the intervention (Day 30) will be evaluated.
Sleep onset latency
Sleep onset latency is defined as the time from attempting to fall asleep to sleep onset, with \>30 minutes generally indicating difficulty initiating sleep. The change from baseline (Day 0) to the end of the intervention (Day 30) will be evaluated.
Multidimensional Fatigue Inventory (MFI-20)
Fatigue will be assessed using the original standard MFI-20. It includes five domains, each scored from 4 to 20, with higher scores indicating greater fatigue. The data will be collected daily from baseline (Day 0) to the end (Day 30).
Fasting blood glucose
Blood samples will be collected at the day of enrollment and 10 and 21 days thereafter to measure fasting blood glucose levels, The normal reference range is 3.9-6.1 mmol/L.
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