Tokyo, Aug. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058796) titled 'Verification research on the effects of test food intake on the intestinal flora in healthy adult men and women with insufficient protein intake' 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 - Re-dermalab Co., Ltd.

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

Objective: Narrative objectives1 - Verify the effect of kinako protein intake on the intestinal flora in healthy adult subjects who are experiencing protein deficiency. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake 50 g of the test food once a day with water or lukewarm water for 12 weeks.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Persons who are aged 18 to 75, both men and women 2. Persons who are not getting enough protein (pre-survey) 3. Persons who are not suffering from any illness related to the stomach or intestines (not diagnosed with any illness), and are concerned about their stomach (stomach or intestines) but have not been judged to require immediate treatment. 4. Persons who fully understand the purpose and content of the research and voluntarily agree to participate in the research Key exclusion criteria - 1. Persons who may experience stomach pain or who have allergies with ingredients containing kinako (soybeans) 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) kinako (soybean) products or have regularly used such products 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 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 - 10

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 12 Month 21 Day Date of IRB - 2024 Year 12 Month 21 Day Anticipated trial start date - 2025 Year 01 Month 01 Day Last follow-up date - 2025 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067231

Disclaimer: Curated by HT Syndication.