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)

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.