UMIN ID: UMIN000055878
Registered date:22/10/2024
An Exploratory Study of the Effects of Consumption of A plant-derived food in Middle-aged and elderly women, including before and after menopause: A Randomized, Double-Blind, Parallel Group Study
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Healthy person |
| Date of first enrollment | 2024/10/22 |
| Target sample size | 160 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Intake of Test Food daily for 12 weeks Intake of Placebo daily for 12 weeks |
Outcome(s)
| Primary Outcome | Profile of Mood States 2nd Edition TMD (Total Mood Disturbance) score,6 Mood scale |
|---|---|
| Secondary Outcome | 1. SMI (Simplified MenopausalIndex) 2. Visual Analogue Scale (Feeling of Fatigue) 3. OSA sleep inventory MA version |
Key inclusion & exclusion criteria
| Age minimum | 40years-old |
|---|---|
| Age maximum | 64years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1. If you are undergoing treatment for menopausal symptoms 2. If you are undergoing treatment for any disease (including medication) at a medical institution 3. If you have a serious illness or a history of serious illness 4. If the subject habitually takes medicines, supplements, nutrient-fortified foods, or iron pills for the purpose of improving menopausal symptoms 5. Have a current or history of drug allergy or food allergy (those who are at risk of developing allergic symptoms to the Test food) 6. Those who have participated or are currently participating in other clinical trials within 1 month of obtaining consent, or those who are scheduled to participate during the study period. 7. Those who drink a lot of alcohol daily (60g alcohol equivalent/day) 8. Those who smoke 9. Those who work at night. 10. Those who are judged to be inappropriate as participants for this study by the research collaborate physician |
Related Information
| Primary Sponsor | Faculty of Agriculture, Kyushu University |
|---|---|
| Secondary Sponsor | 3G Science LLC |
| Source(s) of Monetary Support | SBS Incorporated,Kurume Research Park Co., Ltd., Fukuoka Bioindustry R&D Initiatives 2024 |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masumi Nagae |
| Address | Room 403, Open Design Laboratory Building 2 4-9-1, Shiobaru, Minami-ku Fukuoka City Japan 815-8540 |
| Telephone | 092-553-9458 |
| sffps.hitoshiken@agr.kyushu-u.ac.jp | |
| Affiliation | Faculty of Agriculture Kyushu University Laboratory of Systematic Forest and Forest Products Science |
| scientific contact | |
| Name | Kuniyoshi Shimizu |
| Address | 744 Motooka, Nishiku-Fukuoka City Japan |
| Telephone | 092-802-4675 |
| shimizu.kuniyoshi.381@m.kyushu-u.ac.jp | |
| Affiliation | Faculty of Agriculture, Kyushu University Laboratory of Systematic Forest and Forest Products Science |