Tokyo, July 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058455) titled 'Investigation of the effects of the test food on the regulation of intestinal function' on July 14.

Study Type: Interventional

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

Primary Sponsor: Institute - HUMA R&D CORP

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

Objective: Narrative objectives1 - To investigate the effects of food components in the test food on the regulation of intestinal function in healthy male and female subjects aged 20 to less than 65 years following consumption of the test food. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Continuous intake of the test foods for 2 weeks. Interventions/Control_2 - Continuous intake of the placebo foods for 2 weeks.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1.Japanese males and females who are aged 20 to less than 65 at the time of written informed consent. 2.Subjects who have a tendency toward chronic constipation with 2 to 4 bowel movements per week. 3.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study. Key exclusion criteria - 1.Subjects diagnosed with constipated by a physician. 2.Subjects with brain disease, malignancies, immune disease, diabetes mellitus, liver disease (hepatitis), kidney, heart, thyroid, adrenal, and metabolic diseases, and subjects who currently have or previously had serious manifestations of these conditions. 3.Subject receiving medication or outpatient treatment for a serious disease. 4.Subjects who regularly consume medicines, supplements, or health foods that support the regulation of intestinal function, or foods rich in components that may influence the regulation of intestinal function, such as lactic acid bacteria, bifidobacteria, oligosaccharides, or dietary fiber. 5.Subjects who are receiving drugs that affect the intestinal microbiota such as antibiotics ,or subjects who plan to take such medication during the test period. 6.Subjects who are at risk of having allergic reactions to drugs or foods. 7.Subjects with current or previous history of drug dependence or alcohol dependence. 8.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more). 9.Subjects receiving exercise or diet therapy under the supervision of a physician. 10.Subjects who have extremely irregular life rhythms due to night work, shift work, etc. 11.Subjects whose eating, sleeping, and other habits are extremely irregular. 12.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea syndrome, etc.) , or who has a history of mental illness in the past. 13.Subjects who are having a very unbalanced diet. 14.Smoker 15.Subjects who are currently pregnant or lactating, may become pregnant during the study period. 16.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period. Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 04 Day Date of IRB - 2025 Year 07 Month 11 Day Anticipated trial start date - 2025 Year 07 Month 14 Day Last follow-up date - 2025 Year 10 Month 24 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066799

Disclaimer: Curated by HT Syndication.