Tokyo, Aug. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058792) titled 'Verification research of the effect of test food intake on improving the intestinal environment of healthy elderly people (residents of facilities)' on Aug. 13.

Study Type: Interventional

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

Primary Sponsor: Institute - Nambu Co., Ltd.

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

Objective: Narrative objectives1 - Examine whether foods containing lactic acid bacteria (Lactiplantibacillus plantarum FM8 strain) are actually effective in improving the intestinal environment and QOL (emotions and stress), including mood and immunity, in healthy adult men and women. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake 80 g of test food every day for 4 weeks.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Persons who are residents of elderly welfare facilities 2. Persons who are aged 18 to 100 at the time of consent, both men and women 3. Persons who are not suffering from intestinal diseases (including those who are judged not to require immediate treatment) 4. Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent Key exclusion criteria - 1. Persons who may experience abdominal pain when eating ingredients containing lactic acid bacteria, such as yogurt 2. Persons who have been diagnosed with a digestive disease, previously undergone digestive surgery, and will require digestive surgery in the future 3. Persons who regularly use (at least 3 days a week) ingredients containing lactic acid bacteria, such as yogurt, or have regularly used within the 3 months prior to the pre-test 4. Persons who have been diagnosed with malignant tumors, currently receiving treatment for cranial nerve, heart, kidney, diabetes, or thyroid dysfunction, and with a history of serious illnesses such as liver disease, excluding illnesses like hypertension, which the principal investigator determined will not affect the evaluation of the research. 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 are at risk of developing allergies related to the test foods 7. Persons who are judged unsuitable as research subjects based on their responses to a background survey 8. 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. 9. Persons who are judged to be ineligible by the principal investigator Target Size - 20

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 10 Month 12 Day Date of IRB - 2024 Year 10 Month 12 Day Anticipated trial start date - 2024 Year 10 Month 13 Day Last follow-up date - 2024 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067227

Disclaimer: Curated by HT Syndication.