Research on healthy adult men and women who are tired, diminished in vitality, and dissatisfied with sleep quality in daily life of improvement effect by food intake

Research on healthy adult men and women who are tired, diminished in vitality, and dissatisfied with sleep quality in daily life of improvement effect by food intake - Research on healthy adult men and women who are tired, diminished in vitality, and dissatisfied with sleep quality in daily life of improvement effect by food intake

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000041751

Enrollment

Registered

2021-12-18

Start date

2020-09-11

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 adult

Interventions

Intake of test food daily intake, for 8 weeks Intake of placebo daily intake, for 8 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Men and women between 20 and 64 years of age. (2) Subjects who feel fatigued and less active (3) Subjects with poor sleep quality

Exclusion criteria

Exclusion criteria: (1) Subjects who regularly use health foods containing the ingredients involved in the test food (2) Subjects engaged in actions/drugs or health food use to improve fatigue, stress, or sleep. (3) Subjects with a disease undergoing treatment or with a disease determined to be in need of treatment. (4) Subjects who have, have been diagnosed with, or are strongly suspected of having a sleep-related illness. (5) Subjects with a previous diagnosis of chronic fatigue syndrome (6) Subjects who are being treated for or have a history of mental illness, or are suspected to be suffering from one. (7) Seriously ill subjects and subjects with a history of serious illness (8) Subjects with irregular working days (holidays) (9) Subjects whose lives will become irregular more than once during the research period due to day/night shift work or night work, or who are engaged in physical labor such as heavy lifting. (10) Subjects with major life changes planned during the study period. (11) Subjects who have allergic diseases and are constantly taking therapeutic medication. (12) Subjects with diarrhea (13) Subjects with less than 3 bowel movements per week. (14) Subjects who are pregnant or lactating and who plan to become pregnant or breastfeeding during the study period. (15) Subjects at risk of developing allergies in connection with the study. (16) Subjects whose physical measurements, physical examination values, and clinical examination values at the pre-examination are significantly outside the reference range.

Design outcomes

Primary

Measure	Time frame
POMS2 T-score and OSA-MA at before, 4 and 8 weeks	—

Secondary

Measure	Time frame
SF36 at before, 4 and 8 weeks and flulike symptoms score during intake period	—

Countries

Japan

Contacts

Public ContactYasushi Nakasone

Kenkoukazoku Co., Ltd. None

yasushi.nakasone@kenkoukazoku.co.jp099-223-5211

Outcome results

None listed

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