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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Sleep

Intervention / Treatment
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* Dietary Supplement: Fortified Powdered Beverage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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. Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Participants will be asked to take study product. | Dietary Supplement: Fortified Powdered Beverage<br>* Participants will be asked to take the fortified powdered beverage everyday for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Sleep Issue(s) or Complaint(s)