Safety and efficacy of a dietary supplement containing bovine alpha S1-casein tryptic hydrolysate and Hemerocallis fulva on sleep disorders among Japanese adults

Safety and efficacy of a dietary supplement containing bovine alpha S1-casein tryptic hydrolysate and Hemerocallis fulva on sleep disorders among Japanese adults - Safety and efficacy of a dietary supplement on sleep disorders

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013349

Enrollment

Registered

2014-03-07

Start date

2014-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

sleep disorders

Interventions

A dietary supplement containing bovine alpha S1-casein tryptic hydrolysate and Hemerocallis fulva is administered for 2 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age: more than or equal to 20 years at the time of providing informed consent - Subjects with sleep disorders - Individuals who have never experienced psychological and critical diseases. - Individuals who have the ability to provide written informed consent.

Exclusion criteria

Exclusion criteria: - Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs. - Subjects judged to be inappropriate for the study by the investigator.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is evaluation of sleep quality with a portable physiological signal recorder.	—

Secondary

Measure	Time frame
PSQI (Pittsburgh sleep quality index) and OSA-MA(OSA sleep inventory MA version).	—

Countries

Japan

Contacts

Public ContactSeika Kamohara MD, PhD

DHC Corporation Division of Research Adviser

kamohara-seika@umin.ac.jp0354423945

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026