Tokyo, Nov. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059802) titled 'A study on the health effects of Bifidobacterium and inulin intake in an uncontrolled environment' on Nov. 17.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Ezaki Glico Co., Ltd.

Condition: Condition - healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the effects of consuming a test food and performing regular body composition measurements on body fat in Japanese adults with a BMI of 23 kg/m2 or higher, without any specific lifestyle restrictions. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 1. 8-week continuous intake of a food containing bifidobacterium and inulin 2. Regular body composition measurements

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Male and female employees of Ezaki Glico Co., Ltd., aged 20 to 64 years 2.Subjects who have a body mass index (BMI) of 23.0 kg/m2 or higher 3.Subjects who have received sufficient explanation of the purpose and content of the study, have the capacity to consent, have voluntarily volunteered to participate based on a good understanding of the study, and have agreed to participate in the study in writing Key exclusion criteria - 1. Subjects who have used antibiotics within 2 weeks prior to the start of the study. 2. Subjects who are judged to have difficulty providing written informed consent for the study. 3. Subjects who are pregnant, planning to become pregnant during the study period, or are breastfeeding. 4. Subjects who have excessive alcohol consumption (an average daily intake of 60 g or more of pure alcohol). 5. Subjects who have a known allergy to the investigational food. 6. Subjects who are currently participating in another clinical trial. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 09 Day Anticipated trial start date - 2025 Year 11 Month 18 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=R000068378

Disclaimer: Curated by HT Syndication.