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

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 - An Exploratory Study of the Effects of Consumption of A plant-derived food in Middle-aged and elderly women, including before and after menopause

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000055878

Enrollment

160

Registered

2024-10-22

Start date

2024-10-22

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 person

Interventions

Intake of Test Food daily for 12 weeks Intake of Placebo daily for 12 weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Those who with temporary menopausal symptoms 2. Those who have obtained the prior consent of the individual through electronic consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Profile of Mood States 2nd Edition TMD (Total Mood Disturbance) score,6 Mood scale	—

Secondary

Measure	Time frame
1. SMI (Simplified MenopausalIndex) 2. Visual Analogue Scale (Feeling of Fatigue) 3. OSA sleep inventory MA version	—

Countries

Japan

Contacts

Public ContactMasumi Nagae

Faculty of Agriculture Kyushu University Laboratory of Systematic Forest and Forest Products Science

sffps.hitoshiken@agr.kyushu-u.ac.jp092-553-9458

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026