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Study on the effect and mechanism of casein peptides to improve sleep quality

Study on the effect and mechanism of casein peptides to improve sleep quality

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078334
Enrollment
Unknown
Registered
2023-12-05
Start date
2024-01-01
Completion date
Unknown
Last updated
2023-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

high dose group:Take 4 hydrolyzed casein peptide tablets
placebo group:Take 4 placebo tablets
low dose group:Take 2 hydrolyzed casein peptide tablets

Sponsors

Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-65 years old. 2) Gender is not limited. 3) Body mass index 18.5-23.9 kg/m2. 4) Normal vital signs (blood pressure below 140/90 mmHg (i.e., systolic blood pressure below 140 mmHg, diastolic blood pressure below 90 mmHg, and heart rate between 60-100 bpm). 5) Pittsburgh Sleep Quality Index score >7. 6) Meet the symptoms of primary insomnia. 7) Have signed a written informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients who have been diagnosed with major anxiety and depression. 2)Persons with alcohol or drug dependence. 3) Smoking more than 10 cigarettes per day. 4) Allergic to milk protein or hydrolyzed casein peptide components. 5) Patients with secondary insomnia. 6) Have used medication for insomnia in the month prior to inclusion. 7) Ongoing non-pharmacological treatment for insomnia (e.g., cognitive behavioral therapy, relaxation therapy, etc.). 8) Pregnant or breastfeeding. 9) Those with cancer or other major medical conditions. 10) Those who are unwilling or unable to complete the entire trial.

Design outcomes

Primary

MeasureTime frame
Objective sleep quality;

Secondary

MeasureTime frame
Subjective sleep quality;Subjective daytime function;

Countries

China

Contacts

Public ContactSun Jin

Qingdao University

sunj@qdu.edu.cn+86 181 5155 9959

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026