Ganmaidazao Concentrated Beverage Sleep-Assisting Trial

NCT07726719 | Not Yet Recruiting

• 1 other identifier: GZ260430087
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

A human trial with blind method and self-control design was carried out to evaluate the sleep-improving function of a food. Indicators were detected by professional instruments and self-assessed by subjects. Relevant data before and after 28 consecutive days of test sample administration were collected for comparative analysis.

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI) Total Score

  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.

  Baseline and Day 28

Secondary Outcomes (13)

• Fatigue Scale-14 (FS-14) Total Fatigue Score

  Baseline (Day 0) and Day 28

• Spiegel Sleep Questionnaire Total Score

  Baseline (Day 0) and Day 28

• Change in Objective Total Sleep Time

  Baseline (Day 0) through Day 28 (daily monitoring)

• Salivary melatonin

  Pre-intervention: Day 0 and Day 1; Post-intervention: Day 27 and Day 28. Three sampling time points within 2 hours before bedtime on each collection day.

• Salivary cortisol

  Day 0, Day 1, Day 27, Day 28; four serial sampling points within 45 minutes upon waking each collection day.

Study Arms (1)

Sleep Improvement Functional Food Intervention

EXPERIMENTAL

28-day daily consumption of test functional food, baseline and end-of-study assessments, daily sleep diaries, single-arm self-controlled design

Other: Sleep-improving Functional Food

Interventions

Sleep-improving Functional Food OTHER

28 days of daily consumption of test functional food; sleep assessment via baseline check-up and daily sleep diaries, single-arm self-controlled study.

Sleep Improvement Functional Food Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 60 years of any gender, with a history of staying up late or mild sleep disorder, and Pittsburgh Sleep Quality Index (PSQI) score between 7 and 15 points (mild to moderate sleep impairment).
• Regular daily schedule with bedtime from 22:00 to 24:30 and wake-up time from 6:30 to 8:30; long-term daily schedule fluctuation ≤ 2 hours, and able to maintain a fixed schedule throughout the trial.
• No abnormal saliva secretion and capable of completing saliva sample collection independently and normally.
• Body Mass Index (BMI) ranging from 18.5 to 28.0, without extreme emaciation or obesity.
• Able to participate in pre-trial centralized training and operational assessments (including wearable bracelet wearing, saliva collection, and questionnaire filling), and pass the assessment before enrollment.
• No intake of sleep aids, anti-anxiety drugs, antidepressants, central nervous system regulators, sleep-improving health foods and related products within 2 weeks prior to enrollment.
• Free from severe organic diseases, including cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, psychiatric disorders, and nervous system diseases.
• Free from severe sleep disorder subtypes, such as obstructive sleep apnea syndrome.
• No history of allergy to the ingredients and excipients of the test product, and voluntarily sign the informed consent form.

You may not qualify if:

• Aged under 18 years or over 60 years.
• Current smokers, or subjects with alcohol drinking habits of ≥3 times per week who have not quit alcohol within one month before the trial.
• Long-term intake of stimulating beverages, defined as drinking strong tea, coffee or energy drinks ≥3 cups per day.
• Experienced drastic changes in diet or daily routine within one month before enrollment, such as frequent business trips, travel, shift work, or dramatic dietary habit changes.
• Diagnosed with severe sleep disorders or obstructive sleep apnea syndrome.
• Participated in other human clinical trials, received professional sleep intervention therapy, or consumed products containing N-acetylneuraminic acid within one month before enrollment.
• Pregnant or lactating females, or those planning to become pregnant within one year.
• Long-term shift workers, regular severe night owls, or subjects with extremely unstable sleeping environments.
• Intolerant to wearing smart wearable bracelets or unable to cooperate with trial-related examinations and sample collection.
• Staff of the trial institution and other personnel involved in this project.
• Scheduled to receive surgical treatment during the trial period.
• With a history of severe food or drug allergies.
• Diagnosed with digestive system organic lesions such as gastrointestinal ulcers and bleeding.
• Suffering from severe physical and mental illnesses under treatment, severe cardiovascular, cerebrovascular and hematological diseases, severe liver and kidney dysfunction, pulmonary infection or malignant tumors.

Sponsors & Collaborators

• Sirio Pharma Co., Ltd: lead

Central Study Contacts

Yingzhi N/A Chen

CONTACT

+86 18602053004; gz-chenyingzhi@kingmed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, pre-post intervention study. Participants consume the test food daily for 28 consecutive days, with baseline and end-of-study clinic assessments and daily sleep diary recording, using each participant as their own control.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07