SleepNCT05815147
An Exploratory Real-world Study to Explore the Effects of Fortified Powdered Beverage on Sleep Quality in Chinese Adults with Mild Sleep Issue(s) or Complaint(s)
A study testing Fortified Powdered Beverage in people with Sleep, run by Danone Nutricia at 1 site in China.
Trial summary
The goal of this exploratory study is to explore the sleep and related health benefits of the study product in Chinese middle-aged \& elderly population in real world settings and potentially generate hypothesis on key exploratory and other exploratory objectives. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Fortified Powdered Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2023to 19 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults older than 50 years of age;
- Chinese ethnicity;
- BMI is between 18 and 30 (excluding upper and lower bound values);
- Mild sleep issue(s) and/or complaint(s), including but not limited to difficulty initiating sleep, difficulty maintaining sleep, increased number of nocturnal awakenings, early awakening, complaints of non-restorative sleep, dissatisfaction with sleep quality etc.;
- PSQI score >7 at screening;
- PHQ-4 score ≤ 3 at screening;
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- Sufficient ability in Chinese to complete informed consent and other study documents, and willingness to complete this study according to the study protocol;
- Sufficient ability to install and use a secure WeChat platform on the mobile phone during the study period; stable connectivity to network through mobile phone;
- Sufficient reading and writing and understanding ability in Chinese to complete questionnaires; daily diaries etc.;
- Can be directly contacted by mobile phone or WeChat throughout the study;
- Stable life status with no cross-provincial moving or job changing in the past 6 months, no intention to move or change job during study period.
Who cannot join
- Currently receiving medication and other therapies for sleep disorders, including but not limited to sleeping pills and traditional Chinese medicine or therapies;
- Predominant complaint(s) of parasomnia or sleep apnea and/or medically diagnosed primary sleep disorders including but not limited to obstructive sleep apnea (OSA), narcolepsy, periodic limb movement (PLMD), restless leg syndrome (RLS), or REM sleep behaviors disorder;
- Long-term (≥3 months) use of drugs that induce sleep disturbances, including but not limited to CNS stimulants, anti-depressents, antipsychotics etc.;
- Use sedative drugs within 4 weeks prior to screening;
- Use of dietary supplements with sleep effects within 4 weeks prior to screening including but not limited to melatonin, GABA, Ziziphi Spinosa Semen etc.;
- Average daily caffeinated drinks intake of 5 cups or more (200ml/cup) , including but not limited to coffee, tea, energy drinks, during 4 weeks prior to screening, or during the study period;
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- Allergic or intolerant to the ingredients of the investigational products, such as protein allergy, dairy allergy, lactose intolerance, soy allergy and fish allergy etc. ;
- The presence of drug abuse or alcohol and/or psychoactive substances abuse;
- Those who work night shifts or perform unusal working hours;
- The presence of medical, psychological or social conditions that may interfere with the subject's participation in the study or affect the evaluation of the study results at the investigator's discretion;
- Pregnant and lactating women, caregivers of newborns unsuitable for trial participation at the investigators' discretion;
- Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to enrolment;
- Do not agree to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this exploratory study is to explore the sleep and related health benefits of the study product in Chinese middle-aged \& elderly population in real world settings and potentially generate hypothesis on key exploratory and other exploratory objectives. The main questions it aims to answer are:
- To explore the effects of test product on sleep quality;
- To understand and evaluate effects of test product on sleep pattern;
- To assess the subjects' overall health status self-evaluation. etc.
Participants will be asked to take study product, collect the sleep pattern parameters and report the overall health status.
- Conditions
- Sleep
- Being tested
- Fortified Powdered Beverage
- Keywords
- Mild Sleep Issue(s) or Complaint(s)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified Powdered BeverageDietary supplement
Participants will be asked to take the fortified powdered beverage everyday for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants will be asked to take study product. Receives: Dietary Supplement: Fortified Powdered Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Sleep quality is measured by Chinese version Pittsburgh Sleep Quality Score (CPSQI). The total score ranges from 0 to 21 points. The higher score indicates the worse sleep quality.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start21 Jul 2023
- Primary completion21 Jun 2024
- Study completion19 Feb 2025
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Nutricia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guoping YIN, Principal investigator, Beijing Tsinghua Changgeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815147
- Sponsor's protocol ID
- NELN202209A
- Status last verified
- Feb 2025
- First submitted
- 20 Mar 2023
- Last updated
- 24 Feb 2025
- 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Real-world Study to Explore the Effects of Fortified Powdered Beverage on Sleep Quality in Chinese Adults with Mild Sleep Issue(s) or Complaint(s)
- ClinicalTrials.gov ID
- NCT05815147
- Acronym / sponsor ID
- NELN202209A
- Conditions
- Sleep
- Keywords
- Mild Sleep Issue(s) or Complaint(s)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Danone NutriciaIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 18 Apr 2023 (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.
The goal of this exploratory study is to explore the sleep and related health benefits of the study product in Chinese middle-aged \& elderly population in real world settings and potentially generate hypothesis on key exploratory and other exploratory objectives. The main questions it aims to answer are:
- To explore the effects of test product on sleep quality;
- To understand and evaluate effects of test product on sleep pattern;
- To assess the subjects' overall health status self-evaluation. etc.
Participants will be asked to take study product, collect the sleep pattern parameters and report the overall health status.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Dietary Supplement: Fortified Powdered BeverageParticipants will be asked to take study product. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults older than 50 years of age;
- Chinese ethnicity;
- BMI is between 18 and 30 (excluding upper and lower bound values);
- Mild sleep issue(s) and/or complaint(s), including but not limited to difficulty initiating sleep, difficulty maintaining sleep, increased number of nocturnal awakenings, early awakening, complaints of non-restorative sleep, dissatisfaction with sleep quality etc.;
- PSQI score >7 at screening;
Key exclusion criteria (13 listed)
- Currently receiving medication and other therapies for sleep disorders, including but not limited to sleeping pills and traditional Chinese medicine or therapies;
- Predominant complaint(s) of parasomnia or sleep apnea and/or medically diagnosed primary sleep disorders including but not limited to obstructive sleep apnea (OSA), narcolepsy, periodic limb movement (PLMD), restless leg syndrome (RLS), or REM sleep behaviors disorder;
- Long-term (≥3 months) use of drugs that induce sleep disturbances, including but not limited to CNS stimulants, anti-depressents, antipsychotics etc.;
- Use sedative drugs within 4 weeks prior to screening;
- Use of dietary supplements with sleep effects within 4 weeks prior to screening including but not limited to melatonin, GABA, Ziziphi Spinosa Semen etc.;
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 |
|---|---|---|
| Fortified Powdered BeverageParticipants will be asked to take the fortified powdered beverage everyday for 6 weeks. | Dietary supplement | Study Group |
Primary outcome
Sleep quality
Time frame: 6 weeks
Sleep quality is measured by Chinese version Pittsburgh Sleep Quality Score (CPSQI). The total score ranges from 0 to 21 points. The higher score indicates the worse sleep quality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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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. This study is not recruiting at the moment.
Guoping YIN principal investigator
Beijing Tsinghua Changgeng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortified Powdered Beverage in people with Sleep, run by Danone Nutricia at 1 site in China.
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 11 inclusion and 13 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: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: 6 weeks). 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 Feb 2025.