Verification of the effects of foods containing natural products on cold symptoms.

UMIN ID: UMIN000044259

Registered date:20/06/2022

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: healthy adults
• Date of first enrollment: 2021/05/20
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Foods containing natural products 2 tablets / day
Placebo Foods 2 tablets / day

Outcome(s)

• Primary Outcome: Visual Analogue Scale Number of days with illness
• Secondary Outcome: OSA sleep inventory MA version Chalder Fatigue Scale

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study (2) persons who have changed their habitats to take supplements within past 4 weeks. (3) Persons who work in night shift or in day and night shift (4) persons who have been treated their illness or prevention in a clinic at their informed consent (5) persons with their medical histories as follows: serious diseases of sugar metabolism,lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (6) persons with the medical histories of alcoholism or drug dependence (7) persons who might be developed allergic reaction to foods. (8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period (9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (10)persons who will not be judged suitable to the participants by the investigator.

Related Information

• Primary Sponsor: User Life Science Co., Ltd.
• Secondary Sponsor: Faculty of Agriculture, Kyushu University
• Source(s) of Monetary Support: FS Lab Co., Ltd.