Endocrine Disorder, Fatigue Syndrome, Chronic, Glucose Metabolism Disorder, Lipid Metabolism Disorders, Sleep Disturbance
Conditions
Keywords
Bao Yuan Tang full-component extract, Galactooligosaccharides, Sleep quality, Prebiotic, Metabolic health
Brief summary
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.
Detailed description
The prevalence of suboptimal health status, including sleep disturbances and endocrine dysregulation, has been increasing in recent years, highlighting the significant public health and social implications of developing effective health-promoting interventions. Bao Yuan Tang, a classic traditional Chinese medicine formula with a long history of clinical application, has shown notable benefits in regulating various aspects of suboptimal health status, such as sleep disturbances. All herbs in the composition of Bao Yuan Tang, including Codonopsis Radix (Dangshen), Astragali Radix (Huangqi), Glycyrrhizae Radix et Rhizoma (Gancao), Cinnamomi Cortex (Rougui), Ziziphi Spinosae Semen (Suanzaoren), and charred jujube (Jiaozao), are listed in the catalogue of substances traditionally recognized as both food and Chinese medicinal materials issued by the National Health Commission of the People's Republic of China and the State Administration for Market Regulation. However, high-quality clinical studies evaluating its actual efficacy remain limited to date. Galactooligosaccharides (GOS), forming a widely used class of dietary prebiotics, have also been shown potential benefits in improving conditions such as metabolic abnormalities, constipation, and obesity through modulation of the gut microbiota. Based on these findings, we developed a combination product containing Bao Yuan Tang full-component extract and GOS to investigate whether this combination could exert synergistic effects on improving suboptimal health status. This study is planned to evaluate the effects of a combination product, and Bao Yuan Tang extract or GOS alone, in young female registered nurse aged 25-45 years with night-shift exposure on suboptimal health status-related outcomes, including sleep disturbances, fatigue, endocrine dysregulation, and glucose and lipid metabolic abnormalities. Given the unique occupational characteristics of nursing staff, including irregular working hours and substantial work-related stress, this population considered suitable for inclusion in the present study.
Interventions
DIETARY_SUPPLEMENTCombination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g)
Participants 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.
DIETARY_SUPPLEMENTBao Yuan Tang full-component extract 2.0g plus a placebo consisting of maltodextrin 2.0g
Participants 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.
DIETARY_SUPPLEMENTGalactooligosaccharides 2.0g
Participants 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.
OTHERmaltodextrin placebo 4.0g
Participants will receive maltodextrin placebo (4.0g), administered twice daily, one sachet each time, for 3 weeks.
Sponsors
Hepatopancreatobiliary Surgery Institute of Gansu Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Contains Combination product group, Bao Yuan Tang group, Galactooligosaccharides group and Placebo control group.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Use of medications that may affect study outcomes, including oral contraceptives, glucose-lowering agents, hormonal medications, hypnotics, lipid-regulating agents, or thyroid hormone preparations, within the past 3 months. * Pregnancy, lactation, or planned pregnancy during the study period. * Confirmed severe organic diseases, such as hepatic or renal insufficiency, cardiovascular disease, or malignancy. * Known allergy to any component of the investigational product. * Use of probiotics, prebiotics, or related traditional Chinese medicine preparations within the past 1 month. * Participation in another clinical trial within the past 3 months. * Planned engagement in vigorous exercise or a weight-management program during the study period. * A previous diagnosis of psychiatric disorders, such as anxiety or depression. * Any condition judged by the investigator to involve communication difficulties, poor compliance, or potential interference with adherence to the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | 1 month | 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 | Baseline (day 0), Day 10, and Day 21 | 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 | Baseline (day 0), Day 10, and Day 21 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sleep efficiency | 1 month | 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 | 1 month | 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) | 1 month | 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 | Baseline (day 0), Day 10, and Day 21 | 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. |
| Cluster of differentiation 4 positive/Cluster of differentiation 8 positive T-cell ratio | Baseline (Day 0), Day 10, and Day 21 | Peripheral blood samples will be collected on the day of enrollment and on Days 10 and 21 thereafter to measure the CD4+/CD8+ T-cell ratio by flow cytometry. The normal reference range is approximately 1.5 - 2.5. |
| Serum estradiol (E2) | Baseline (Day 0), Day 10, and Day 21 | Blood samples will be collected on the day of enrollment and on Days 10 and 21 thereafter to measure serum estradiol (E2) levels. The reference ranges are 20 - 250 pg/mL in the follicular phase, 190 - 649 pg/mL during ovulation, and 21 - 350 pg/mL in the luteal phase. |
| Gut microbiota analysis | Baseline (day 0), Day 10, and Day 21 | Stool samples will be collected on the day of enrollment and on Days 10 and 21 thereafter for gut microbiota analysis, Changes in α-diversity, β-diversity, and differential microbiota will be assessed. |
Countries
China
Contacts
CONTACTWenbo Meng, M.D., Ph.D.
CONTACTLiang Tian, M.D.
PRINCIPAL_INVESTIGATORWenbo Meng, M.D., Ph.D.
LanZhou University
Outcome results
None listed