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)

Sleep Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815147
• Other study ID #: NELN202209A
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Danone Nutricia
• Contact: Camille YU
• Phone: +8618817338946
• Email: camille.yu[@]danone.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sleep

Intervention

Dietary Supplement:
• Fortified Powdered Beverage
Participants will be asked to take the fortified powdered beverage everyday for 6 weeks.

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgeng Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Danone Nutricia

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	total sleep time (TST) for Sleep pattern	Total sleep time, the amount of actual sleep time in a sleep episode; Unit: minute.	6 weeks
Other	Number of wakening after sleep onset (WASO) for Sleep pattern	The number of wakening times during a sleep episode; Unit: time.	6 weeks
Other	Heart Rate (HR) for Sleep pattern	Heart Rate (HR) during sleep episode; Unit: beats per minute (BPM).	6 weeks
Other	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
Other	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
Other	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
Primary	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