Tokyo, March 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060813) titled 'Research on the Effects of Genistein-Containing Intake on Menopausal Hand' on March 3.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Hokkaido University Hospital
Condition:
Condition - Research on the Effects of Genistein-Containing Intake on Menopausal Hand
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to investigate the effects of genistein intake on menopausal hand.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants are instructed to take one capsule daily of a functional food containing 13.5 mg of genistein for three months, and changes in menopausal hand symptoms are evaluated.
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Female
Key inclusion criteria - Individuals capable of consuming genistein-containing functional foods daily for three months.
Individuals capable of attending outpatient visits one month, two months, and three months after consuming the functional food.
Individuals who, after receiving sufficient explanation regarding participation in this study, provided written consent based on full understanding and their own free will.
Individuals who received explanations about both the equol-containing functional food and the genistein-containing functional food and expressed a desire to consume the genistein-containing functional food.
Key exclusion criteria - Individuals wishing to consume other functional foods containing soy isoflavones.
Individuals with abnormal liver or kidney function detected in pre-study blood tests.
Other individuals deemed unsuitable as study subjects by the principal investigator.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 03 Day
Anticipated trial start date - 2026 Year 03 Month 09 Day
Last follow-up date - 2027 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069582
Disclaimer: Curated by HT Syndication.