Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055575) titled 'Effects of consumption of the test food on psychological and physical condition in menopausal women' on Dec. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Fujico Co., Ltd.

Condition: Condition - Healthy Japanese subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on psychological and physical condition in menopausal women Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Daily intake of test food X for 12 weeks Interventions/Control_2 - Daily intake of test food Y for 12 weeks

Eligibility: Age-lower limit - 40 years-old = Gender - Female Key inclusion criteria - 1) Females aged 40 or more and 64 or less 2) Subjects whose SMI total score of 50 or less 3) Subjects who experience stress, low mood or fatigue in their daily life 4) Subjects who can give informed consent to participate in this study Key exclusion criteria - 1)Subjects who are allergic to the test food 2)Subjects who are undergoing medical treatment of gynecological such as climacteric disorder and dysmenorrhea 4) Subjects who are undergoing medical treatment of mental disease 5) Subjects who undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 6)Subjects who are constantly taking pill or herbal medicines 7)Subjects who are undergoing hormone replacement therapy 8) Subjects who have a history of ovariectomy or hysterectomy 9) Subjects who consume 50mg or more of soy isoflavones on a daily basis 10) Subjects who have passed more than 5 years after menopause 11) Subjects who take health food (supplement or "Foods with functional claims" or "Food for specified health uses") affecting fatigue, stress or sleep quality 12) Subjects who are pregnant or lactating, or intending to become pregnant during the study 13) Subjects who took part in another clinical study within 28 days prior to the start of the present study or who is currently taking part in another clinical study 14) Subjects who are judged as ineligible to participate in this study by the principal investigator Target Size - 104

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 07 Month 31 Day Date of IRB - 2024 Year 08 Month 02 Day Anticipated trial start date - 2024 Year 09 Month 20 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063461

Disclaimer: Curated by HT Syndication.