Effect of taking foods with Enoki mushrooms (Flammulina velutipes) on mental and physical health in adult women

UMIN ID: UMIN000046734

Registered date:16/03/2023

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adult women
• Date of first enrollment: 2022/01/28
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

To take 30 g of the food with Enoki mushrooms / day for 4 weeks
To take 30 g of the placebo food / day for 4 weeks

Outcome(s)

• Primary Outcome: Evaluation of skin condition by measuring instruments
• Secondary Outcome: Visual Analog scale of skin condition Stool Form Scale Profile of Mood States 2nd Edition

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Female
• Exclude criteria: (1) Persons who have any dietary supplements, quasi drugs or medicines which demonstrate the same or similar efficacy as 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 are under treatment or determined to require medical treatment as at obtaining 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, the nervous system or mental illness (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 within the past four weeks. (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: Graduate School of Kyushu University Faculty of Agriculture
• Secondary Sponsor: Faculty of Humanity-Oriented Science and Engineering, Kindai University
• Source(s) of Monetary Support: Hakutakekan Fukuoka Agricultural Corporations Association