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Clinical Study to Investigate the Effect of the Functional Food on Improving Minor Health Complaints: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study

Clinical Study to Investigate the Effect of the Functional Food on Improving Minor Health Complaints: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study - Clinical Study to Investigate the Effect of the Functional Food on Improving Minor Health Complaints:

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048849
Enrollment
90
Registered
2022-09-05
Start date
2022-09-06
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 adults

Interventions

Daily ingestion 23 g of the active test food-1 for 4 weeks. Daily ingestion 23 g of the active test food-2 for 4 weeks. Daily ingestion 23 g of the placebo test food for 4 weeks.

Sponsors

Hokkaido Information University
Lead Sponsor
Kyushu University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects who agree to participate in this study with a written informed consent. 2. Subjects with a minor health complaints.

Exclusion criteria

Exclusion criteria: 1. Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, sleep disorders, and/or chronic fatigue syndrome. 2. Subjects who receive nourishment instruction. 3. Subjects with implantable electronic medical devices. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7. Subjects with severe anemia. 8. Pre- or post-menopausal women complaining of obvious physical changes. 9. Subjects who are at risk of having allergic reactions to drugs or foods especially based on wheat, soybean, egg, milk, cocoa. 10. Subjects who regularly take medicine, functional foods, and/or supplements which would affect sleep and/or stress. 11. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 12. 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. 13. Pregnant or lactating women or women who expect to be pregnant during this study. 14. Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to the current study. 15. Subjects whose lifestyle is expected to change significantly. 16. 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
The Brief Job Stress Questionnaire (Section B) after 4 weeks of ingestion.

Secondary

MeasureTime frame
Survey on subjects' sleeping, bowel movement, mental and physical condition, sense of accomplishment.

Countries

Japan

Contacts

Public ContactJun NISHIHIRA

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