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)

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 Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Dietary supplement: Fortified Powdered Beverage

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tsinghua Changgeng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Participants will be asked to take study product.	Dietary supplement: Fortified Powdered Beverage; Participants will be asked to take the fortified powdered beverage everyday for 6 weeks.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Danone Nutricia
• Investigators: Principal Investigator: Guoping YIN, Beijing Tsinghua Changgeng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Actual): June 21, 2024
• Study Completion (Actual): February 19, 2025

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Mild Sleep Issue(s) or Complaint(s)
• Other Study ID Numbers: NELN202209A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No