A sip for better sleep? beverage put to the test
NCT ID NCT07726719
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial tests whether a concentrated beverage taken daily for 28 days can improve sleep quality in adults aged 18 to 60 with mild sleep issues. Participants keep sleep diaries and complete questionnaires on sleep quality and fatigue. The study uses a single-arm design, meaning everyone receives the beverage, and compares results before and after the trial period.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a functional food beverage (Ganmaidazao concentrated beverage)
- What this could lead to
- If it works, this could point toward a simple, non-drug option for improving sleep quality in people with mild sleep disturbances.
- What could go wrong
- This is a very small, early trial with only 25 participants and no placebo control, so results may not be reliable or generalizable. The beverage is a food product, so any sleep benefits may be modest.
Why investors are watching
Sirio Pharma is running a 25-person trial of a Ganmaidazao concentrated beverage to see if it improves sleep after 28 days of daily use. For a small-cap company, this readout matters because a positive result could support a health claim for a commercial food product, which may broaden its consumer appeal. The trial uses a blind, self-control design, meaning each participant serves as their own comparison, which strengthens the evidence despite the small size.
If it works: A positive result could let Sirio Pharma market the beverage with a sleep-support claim, potentially opening a new revenue line for a company of this size. Success in a human trial, even a small one, may also build credibility for its broader product pipeline.
If it fails: A negative or unclear result would likely end the sleep claim and could hurt the product's commercial prospects. Trials fail often, and with only 25 participants, the outcome may not be conclusive either way.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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