Clinical trial NCT05815147: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Mild Sleep Issue(s) or Complaint(s)
Lead sponsor: Danone Nutricia
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Adults older than 50 years of age;
2. Chinese ethnicity;
3. BMI is between 18 and 30 (excluding upper and lower bound values);
4. 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.;
5. PSQI score \>7 at screening;
6. PHQ-4 score ≤ 3 at screening;
7. Sufficient ability in Chinese to complete informed consent and other study documents, and willingness to complete this study according to the study protocol;
8. 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;
9. Sufficient reading and writing and understanding ability in Chinese to complete questionnaires; daily diaries etc.;
10. Can be directly contacted by mobile phone or WeChat throughout the study;
11. 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:

1. Currently receiving medication and other therapies for sleep disorders, including but not limited to sleeping pills and traditional Chinese medicine or therapies;
2. 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;
3. Long-term (≥3 months) use of drugs that induce sleep disturbances, including but not limited to CNS stimulants, anti-depressents, antipsychotics etc.;
4. Use sedative drugs within 4 weeks prior to screening;
5. Use of dietary supplements with sleep effects within 4 weeks prior to screening including but not limited to melatonin, GABA, Ziziphi Spinosa Semen etc.;
6. 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;
7. Allergic or intolerant to the ingredients of the investigational products, such as protein allergy, dairy allergy, lactose intolerance, soy allergy and fish allergy etc. ;
8. The presence of drug abuse or alcohol and/or psychoactive substances abuse;
9. Those who work night shifts or perform unusal working hours;
10. 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;
11. Pregnant and lactating women, caregivers of newborns unsuitable for trial participation at the investigators' discretion;
12. Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to enrolment;
13. Do not agree to sign the informed consent.

Primary outcomes:
measure: Sleep quality
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
measure: total sleep time (TST) for Sleep pattern
timeFrame: 6 weeks
measure: Number of wakening after sleep onset (WASO) for Sleep pattern
timeFrame: 6 weeks
measure: Heart Rate (HR) for Sleep pattern
timeFrame: 6 weeks
measure: Quality of life for overall health status self-evaluation
timeFrame: 6 weeks
measure: Stress level for overall health status self-evaluation
timeFrame: 6 weeks
measure: Fatigue level for overall health status self-evaluation
timeFrame: 6 weeks
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgeng Hospital
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: Guoping YIN
role: PRINCIPAL_INVESTIGATOR
References: