Bao Yuan Tang Extract and Galactooligosaccharides for Sleep Regulation

NCT07774897 | Not Yet Recruiting

• 1 other identifier: BYT-GOS-RCT-2026
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 6

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.

Conditions

Sleep Disturbance; Fatigue Syndrome, Chronic; Endocrine Disorder; Glucose Metabolism Disorder; Lipid Metabolism Disorders

Keywords

Bao Yuan Tang full-component extract; Galactooligosaccharides; Sleep quality; Prebiotic; Metabolic health

Outcome Measures

Primary Outcomes (3)

• 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).

  1 month

• 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.

  Baseline (day 0), Day 10, and Day 21

• 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.

  Baseline (day 0), Day 10, and Day 21

Secondary Outcomes (7)

• Changes in sleep efficiency

  1 month

• Sleep onset latency

  1 month

• Multidimensional Fatigue Inventory (MFI-20)

  1 month

• Fasting blood glucose

  Baseline (day 0), Day 10, and Day 21

• Cluster of differentiation 4 positive/Cluster of differentiation 8 positive T-cell ratio

  Baseline (Day 0), Day 10, and Day 21

Study Arms (4)

Combination product group

EXPERIMENTAL

Bao Yuan Tang full-component extract (2.0g) and galactooligosaccharides (2.0g).

Dietary Supplement: Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g)

Bao Yuan Tang group

ACTIVE COMPARATOR

Bao Yuan Tang full-component extract (2.0g) plus a placebo consisting of maltodextrin (2.0g).

Dietary Supplement: Bao Yuan Tang full-component extract 2.0g plus a placebo consisting of maltodextrin 2.0g

Galactooligosaccharides group

ACTIVE COMPARATOR

galactooligosaccharides (2.0g) combined with a maltodextrin placebo (2.0g).

Dietary Supplement: Galactooligosaccharides 2.0g

Placebo control group

PLACEBO COMPARATOR

maltodextrin placebo (4.0g).

Other: maltodextrin placebo 4.0g

Interventions

Bao Yuan Tang full-component extract 2.0g plus a placebo consisting of maltodextrin 2.0g DIETARY_SUPPLEMENT

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.

Bao Yuan Tang group

Galactooligosaccharides 2.0g DIETARY_SUPPLEMENT

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.

Galactooligosaccharides group

maltodextrin placebo 4.0g OTHER

Participants will receive maltodextrin placebo (4.0g), administered twice daily, one sachet each time, for 3 weeks.

Placebo control group

Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g) DIETARY_SUPPLEMENT

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.

Combination product group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: Female registered nurses aged 25-45 years.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (6)

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

The Second Hospital & Clinical Medical School, Lanzhou University

Lanzhou, Gansu, 730030, China

Location

The Fourth Affiliated Hospital of Hebei University of Traditional Chinese Medicine

Shijiazhuang, Hebei, 050031, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, 441000, China

Location

The Seventh Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830028, China

Location

The First People's Hospital of Yunnan Province

Kunming, Yunnan, 650832, China

Location

Related Publications (5)

• Tian L, Lin Y, Yue P, Gao L, Wang L, Huang C, Zhao J, Jiang N, Xi J, Ma H, Liu Z, Zhong R, Fu W, Mi N, Bai M, Zhang B, Dai L, Li J, Chen H, Yuan J, Meng W. Oat β-Glucan and Galactooligosaccharides Influence Gallstone Formation by Modulating the Gut Microbiota, Particularly Desulfovibrionales. iMetaMed. 2026;2(1):e70029. doi: 10.1002/imm3.70029.

  RESULT

• van Oortmerssen JAE, Mulder JWCM, Kavousi M, Roeters van Lennep JE. Lipid metabolism in women: A review. Atherosclerosis. 2025 Jun;405:119213. doi: 10.1016/j.atherosclerosis.2025.119213. Epub 2025 Apr 24.

  PMID: 40300433 RESULT

• Chen HC, Hsu NW, Chou P. Subgrouping Poor Sleep Quality in Community-Dwelling Older Adults with Latent Class Analysis - The Yilan Study, Taiwan. Sci Rep. 2020 Mar 25;10(1):5432. doi: 10.1038/s41598-020-62374-4.

  PMID: 32214167 RESULT

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 RESULT

• As-Sanie S, Mackenzie SC, Morrison L, Schrepf A, Zondervan KT, Horne AW, Missmer SA. Endometriosis: A Review. JAMA. 2025 Jul 1;334(1):64-78. doi: 10.1001/jama.2025.2975.

  PMID: 40323608 RESULT

MeSH Terms

Conditions

Parasomnias; Fatigue Syndrome, Chronic; Endocrine System Diseases; Glucose Metabolism Disorders; Lipid Metabolism Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Wenbo Meng, M.D., Ph.D.

  LanZhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenbo Meng, M.D., Ph.D.

CONTACT

+8613919177177; mengwb@lzu.edu.cn

Liang Tian, M.D.

CONTACT

+8615293146623; tianl2024@lzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Model Details: Contains Combination product group, Bao Yuan Tang group, Galactooligosaccharides group and Placebo control group.

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 19, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)