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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:
Participants will be asked to take study product, collect the sleep pattern parameters and report the overall health status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Participants will be asked to take study product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortified Powdered Beverage | Dietary Supplement | Participants will be asked to take the fortified powdered beverage everyday for 6 weeks. |
|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| total sleep time (TST) for Sleep pattern | Total sleep time, the amount of actual sleep time in a sleep episode; Unit: minute. | 6 weeks |
| Number of wakening after sleep onset (WASO) for Sleep pattern | The number of wakening times during a sleep episode; Unit: time. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guoping YIN | Beijing Tsinghua Changgeng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgeng Hospital | Beijing | China |
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| 6 weeks |
| Heart Rate (HR) for Sleep pattern | Heart Rate (HR) during sleep episode; Unit: beats per minute (BPM). | 6 weeks |
| Quality of life for overall health status self-evaluation | Quality of life Questionnaire: The World Health Organization Quality of Life - BREF (WHOQOL-BREF, Chinese version). WHOQOL - BREF scale includes 24 items of physical, psychological, social, and environmental in 4 areas and overall quality of life perception and health status. The higher the total score is, the better quality of life is. | 6 weeks |
| Stress level for overall health status self-evaluation | Stress level Questionnaire: Perceived Stress Scale, PSS-10. PPS-10 is rated on a 5-point likert scale where 0=Never, 1=Almost Never, 2=Sometimes, 3=Fairly Often, 4=Very Often. The higher the total score is, the more severe the stress level is. | 6 weeks |
| Fatigue level for overall health status self-evaluation | Fatigue level Questionnaire: Fatigue Assessment Scale, FAS. FAS is a 10-item general fatigue questionnaire to assess fatigue. Five questions reflect physical fatigue and 5 questions (questions 3 and 6-9) mental fatigue.The total score of FAS ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue. | 6 weeks |