Clinical Study to Investigate the Effect of the Functional Food on Improving Minor Health Complaints: An Open-Label, Uncontrolled Pilot Study

UMIN ID: UMIN000045471

Registered date:17/09/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2021/09/24
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The subjects take the test food during 8weeks (5meals/ w and 1meal/ d).

Outcome(s)

• Primary Outcome: The Brief Job Stress Questionnaire (Section B) at 8weeks after beginning the intake of test food.
• Secondary Outcome: Blood pressure, pulse rate, body weight, BFP, basal metabolic rate, muscle mass, internal water content, BMI, survey on subjects' sleeping, bowel movement, mental and physical condition, sense of accomplishment, change of daily behavior

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1.Subjects with implantable electronic medical devices. 2.Subjects who receive nourishment instruction. 3.Subjects who cannot take the test food during 8weeks because of allergy risk and so on. 4.Subjects whose lifestyle is expected to change significantly. 5.Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to the current study. 6.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.

Related Information

• Primary Sponsor: Hokkaido Information University
• Source(s) of Monetary Support: National Agriculture and Food Research Organization, bio-oriented technology Research Advancement Institution