Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058849) titled 'Evaluation research on the improvement of the intestinal environment in healthy adults by ingestion of test foods' on Aug. 20.

Study Type: Interventional

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

Primary Sponsor: Institute - Nambu Co., Ltd.

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

Objective: Narrative objectives1 - Examine whether foods containing kestose and agarooligosaccharides (intestinal active powdered drinks) are actually effective in improving the intestinal environment and QOL (emotions and stress), including immunity, in healthy adult men and women, and to examine the safety of using them in combination. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake test food (9 g) dissolved in water or lukewarm water (100 ml) once a day for 4 weeks. Interventions/Control_2 - Intake placebo (9 g) dissolved in water or lukewarm water (100 ml) once a day for 4 weeks.

Eligibility: Age-lower limit - 65 years-old

Gender - Male and Female Key inclusion criteria - 1. Persons who are aged 65 to 100 at the time of consent, both men and women 2. Persons who are not suffering from a disease directly related to the study (including those who are judged not to need to start new treatment immediately) 3. Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent by themselves or legal representative Key exclusion criteria - 1. Persons who may experience abdominal pain when eating ingredients containing kestose and agarooligosaccharides 2. Persons who have been diagnosed with a digestive disease (diseases involving digestive inflammation, such as inflammatory bowel disease) and those who will require digestive surgery in the future. 3. Persons who regularly use (at least 3 days a week) kestose and agarooligosaccharides 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 implementing physician in charge 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 - 40

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 02 Month 01 Day Date of IRB - 2025 Year 02 Month 01 Day Anticipated trial start date - 2025 Year 02 Month 02 Day Last follow-up date - 2025 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067293

Disclaimer: Curated by HT Syndication.