Tokyo, July 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058634) titled 'Examination of the effects of test foods on bone and intestinal environment depending on dietary habits' on July 29.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - BIOSIS Lab. Co., Ltd.

Condition: Condition - Healthy Adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Exploratory evaluate the effects of the test food on bone and intestinal environment when it is ingested for 4 consecutive weeks in Japanese adult women who have been postmenopausal for at least one year. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Persons who normally consume kestose, intake 6 g (one spoonful) of the test food every day for four weeks, at any time. Interventions/Control_2 - Persons who do not normally consume kestose, intake 6 g (one spoonful) of the test food every day for four weeks, at any time.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - 1. Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate 2. Persons who are Japanese adult women who have been postmenopausal for at least one year Key exclusion criteria - 1. Persons who have chronic illness, receiving medication, have a serious disease history 2. Persons who are allergic to the test food 3. Persons who usually take a large amount of test food 4. Persons who usually take medicine, specified health food, healthy food and supplements that may have effect to bone or bacterial flora 5. Persons who drink a large amount of alcohol (60 g or more of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 cups of sake, or 180 mL of double-sized whiskey) 6. Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research. 7. Persons who are judged to be ineligible by the principal investigator Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 05 Month 16 Day Date of IRB - 2025 Year 05 Month 16 Day Anticipated trial start date - 2025 Year 05 Month 17 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067049

Disclaimer: Curated by HT Syndication.