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A study of the effects of test food on stress, sleep quality and fatigue -A randomized, double-blind, placebo-controlled, parallel study

A study of the effects of test food on stress, sleep quality and fatigue -A randomized, double-blind, placebo-controlled, parallel study - A study of the effects of test food on stress, sleep quality and fatigue

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049989
Enrollment
52
Registered
2023-01-08
Start date
2023-01-11
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 subjects who are stressed and have problems such as sleep quality or fatigue (Non-chronic, non-illness)

Interventions

Oral intake of the test foods (1 drink in a day for 8 weeks) Oral intake of the placebo foods (1 drink in a day for 8 weeks)

Sponsors

Kanyukai clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy subjects who are stressed and have problems such as sleep quality or fatigue (Non-chronic, non-illness) 2) Healthy adults aged 40 to 75 years old. 3) Gender: No preference 4) Subjects without smoking habits 5) Subjects who do not have a habit of taking a meal containing test foods 6)Subjects who do not regularly use supplements and health foods 7) Subjects who do not suffer from lifestyle diseases (high blood pressure, diabetes etc.), rheumatism, liver disorders, renal disorders, other chronic diseases 8) Subjects who have no history of treatment of malignant tumor, heart failure, myocardial infarction 9) Subjects who have no history of allergy to test foods / medicines 10) Subjects who do not take medication for Outpatient treatment 11) Subjects giving written informed consent

Exclusion criteria

Exclusion criteria: 1) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period 2) Subjects who are participating the other clinical tests. Subjects who participated within 3-month prior to the current study 3) Subjects who do not comply with instructions from the doctor or medical staff 4) Others who have been determined ineligible by investigator

Design outcomes

Primary

MeasureTime frame
Evaluation of stress, sleep quality and fatigue by SRS-18, POMS2, Izumo Scale, OSA-MA, VAS at 0 week and at 8 weeks

Countries

Japan

Contacts

Public ContactTaisuke Fukaya

Tashikani Plus Co., Ltd CEO

fukaya@tashikani.jp06-6352-6622

Outcome results

None listed

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