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Effect of Daily Ingestion of test food on improving Sleep Quality and Stress: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Effect of Daily Ingestion of test food on improving Sleep Quality and Stress: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study - Effect of Daily Ingestion of test food on improving Sleep Quality and Stress

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044813
Enrollment
90
Registered
2021-07-27
Start date
2021-10-09
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

Healthy Adult

Interventions

Sponsors

Hokkaido Information University
Lead Sponsor
National Agriculture and Food Research Organization
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects who agree to participate in this study with a written informed consent. 2. Japanese males and females between 20 and 65 years old at the time of screening test. 3. Subjects who feel stress.

Exclusion criteria

Exclusion criteria: 1) Subjects who are under physician's advice, treatment, and/or medication for insomnia, depression, Parkinson's disease, mood disorder, sleep apnea syndrome, nocturnal polyuria, benign prostatic hypertrophy, overactive bladder, hyperlipidemia and/or diabetes, etc. 2) The OABSS score of Q3 >=2, and the total score >= 3. 3) Subjects with suspected sleep apnea syndrome. 4) Subjects who take medicines, herbs, and/or supplements that reducing blood sugar, inhibiting blood clotting and/or platelet aggregation. 5) Subjects who take antihypertensive agents. 6) Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 7) Subjects with major surgical history relevant to the digestive system. 8) Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data. 9) Subjects with severe anemia. 10) Pre- or post-menopausal women complaining of obvious physical changes. 11) Subjects who are at risk of having allergic reactions to drugs and/or foods. 12) Subjects who take medicine and/or functional foods which would affect sleep and/or stress 4 days or more per week. 13) Heavy smokers, alcohol addicts and/or subjects with disordered lifestyle. 14) Subjects whose lifestyle is expected to change. 15) Subjects who live with infants. 16) Subjects who may be awakened at night for care. 17) Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to the current study. 18) Pregnant or lactating women or women who expect to be pregnant. 19) Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to the current study. 20) Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Sleep questionnaire

Secondary

MeasureTime frame
Sleep and stress questionnaires, objective evaluation (instrument measurement) of sleep and stress, body composition, blood lipids, etc.

Countries

Japan

Contacts

Public ContactNaoyuki HONMA

Hokkaido Information University Health Information Science Center

hisc-acad.res@s.do-johodai.ac.jp011-385-4430

Outcome results

None listed

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