SleepNCT07726719
Ganmaidazao Concentrated Beverage Sleep-Assisting Trial
A study testing Sleep-improving Functional Food in people with Sleep, run by Sirio Pharma Co., Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep-improving Functional Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
The objective of this clinical trial is to evaluate whether a food product has the effect of improving sleep. The primary research question is: does a full course of consumption improve sleep outcomes in study participants? This is a single-arm trial comparing participants' sleep status before and after consumption of the test product.
Study participants will:
Consume the test article daily for 28 consecutive days Attend clinic assessments at baseline (prior to trial initiation) and after the 28-day intervention period Maintain daily sleep diaries throughout the study period
- Conditions
- Sleep
- Being tested
- Sleep-improving Functional Food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep-improving Functional FoodOther
28 days of daily consumption of test functional food; sleep assessment via baseline check-up and daily sleep diaries, single-arm self-controlled study.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Sleep-improving Functional Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 28
Secondary outcomes (13)
Fatigue Scale-14 (FS-14) Total Fatigue Score
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.
Measured: Baseline (Day 0) and Day 28
Spiegel Sleep Questionnaire Total Score
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.
Measured: Baseline (Day 0) and Day 28
Change in Objective Total Sleep Time
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.
Measured: Baseline (Day 0) through Day 28 (daily monitoring)
Salivary melatonin
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.
Measured: 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
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.
Measured: Day 0, Day 1, Day 27, Day 28; four serial sampling points within 45 minutes upon waking each collection day.
Change in Objective Sleep Efficiency
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.
Measured: Baseline (Day 0) through Day 28 (daily monitoring)
Change in Objective Deep Sleep Duration
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.
Measured: Baseline (Day 0) through Day 28 (daily monitoring)
Change in Objective Sleep Onset Latency
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.
Measured: Baseline (Day 0) through Day 28 (daily monitoring)
Change in Actual Bedtime Recorded via Daily Sleep Diary
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.
Measured: Baseline (Day 0) through Day 28 (daily self-report sleep diary)
Change in Wake-up Time Recorded via Daily Sleep Diary
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.
Measured: Baseline (Day 0) through Day 28 (daily self-report sleep diary)
Change in Perceived Sleep Quality from Daily Sleep Diary
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.
Measured: Baseline (Day 0) through Day 28 (daily self-report sleep diary)
Change in Number of Nighttime Awakenings Recorded via Daily Sleep Diary
Participants record the daily count of nighttime awakenings in sleep diaries from Day 0 to Day 28. Changes relative to baseline will be reported.
Measured: Baseline (Day 0) through Day 28 (daily self-report sleep diary)
Frequency of Daily Sleep-related Discomfort Recorded via Sleep Diary
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.
Measured: Baseline (Day 0) through Day 28 (daily self-report sleep diary)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion5 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sirio Pharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726719
- Sponsor's protocol ID
- GZ260430087
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ganmaidazao Concentrated Beverage Sleep-Assisting Trial
- ClinicalTrials.gov ID
- NCT07726719
- Acronym / sponsor ID
- GZ260430087
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sirio Pharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this clinical trial is to evaluate whether a food product has the effect of improving sleep. The primary research question is: does a full course of consumption improve sleep outcomes in study participants? This is a single-arm trial comparing participants' sleep status before and after consumption of the test product.
Study participants will:
Consume the test article daily for 28 consecutive days Attend clinic assessments at baseline (prior to trial initiation) and after the 28-day intervention period Maintain daily sleep diaries throughout the study period
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sleep Improvement Functional Food Intervention | Experimental | Other: Sleep-improving Functional Food28-day daily consumption of test functional food, baseline and end-of-study assessments, daily sleep diaries, single-arm self-controlled design |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep-improving Functional Food28 days of daily consumption of test functional food; sleep assessment via baseline check-up and daily sleep diaries, single-arm self-controlled study. | Other | Sleep Improvement Functional Food Intervention |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI) Total Score
Time frame: Baseline and Day 28
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.
13 secondary outcomes
Fatigue Scale-14 (FS-14) Total Fatigue Score
Time frame: Baseline (Day 0) and Day 28
Spiegel Sleep Questionnaire Total Score
Time frame: Baseline (Day 0) and Day 28
Change in Objective Total Sleep Time
Time frame: Baseline (Day 0) through Day 28 (daily monitoring)
Salivary melatonin
Time frame: 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
Time frame: Day 0, Day 1, Day 27, Day 28; four serial sampling points within 45 minutes upon waking each collection day.
Change in Objective Sleep Efficiency
Time frame: Baseline (Day 0) through Day 28 (daily monitoring)
Change in Objective Deep Sleep Duration
Time frame: Baseline (Day 0) through Day 28 (daily monitoring)
Change in Objective Sleep Onset Latency
Time frame: Baseline (Day 0) through Day 28 (daily monitoring)
Change in Actual Bedtime Recorded via Daily Sleep Diary
Time frame: Baseline (Day 0) through Day 28 (daily self-report sleep diary)
Change in Wake-up Time Recorded via Daily Sleep Diary
Time frame: Baseline (Day 0) through Day 28 (daily self-report sleep diary)
Change in Perceived Sleep Quality from Daily Sleep Diary
Time frame: Baseline (Day 0) through Day 28 (daily self-report sleep diary)
Change in Number of Nighttime Awakenings Recorded via Daily Sleep Diary
Time frame: Baseline (Day 0) through Day 28 (daily self-report sleep diary)
Frequency of Daily Sleep-related Discomfort Recorded via Sleep Diary
Time frame: Baseline (Day 0) through Day 28 (daily self-report sleep diary)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep-improving Functional Food in people with Sleep, run by Sirio Pharma Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingzhi N/A Chen (+86 18602053004, gz-chenyingzhi@kingmed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) Total Score (time frame: Baseline and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.