Clinical Trial: Effects of daily ingestion of the dietary ingredient on bowel movement and the intestinal environment: a randomized, placebo-controlled, double-blind, parallel-group trial (Japan)

Tokyo, Aug. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058822) titled 'Effects of daily ingestion of the dietary ingredient on bowel movement and the intestinal environment: a randomized, placebo-controlled, double-blind, parallel-group trial' on Aug. 18.

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 - YES

Objective: Narrative objectives1 - To investigate the effects of continuous consumption of dietary ingredient on bowel movements and the intestinal environment in healthy adult men and women aged 20 to less than 70 years. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Continuous ingestion of the test food 1 for 4 weeks Interventions/Control_2 - Continuous ingestion of the test food 2 for 4 weeks

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1.Healthy Japanese males and females who are aged 20 to under 70 years at the time of written informed consent. 2.Subjects who defecate three to five times per week at screening period. 3.Subjects whose BMI is less than 30 kg/m2. 4.Subjects who have regular eating habits every day and are able to generally eat three meals a day during the study. 5.Subjects who have been fully informed the purpose and details of the study, have the 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 in writing. Key exclusion criteria - 1.Subjects diagnosed with constipated by a physician or have diseases that may substantially affect bowel movement. 2.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases. 3.Subjects receiving medication or outpatient treatment for a serious disease. 4.Subjects receiving exercise or diet therapy under the supervision of a physician. 5.Subjects with current or previous history of drug dependence or alcohol dependence. 6.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder. 7.Subjects who are taking antibiotics or other medications that affect the gut microbiome or who plan to take these during the study. 8.Subjects who regularly use bowel-regulating drugs (including traditional Chinese medicines), quasi-drugs (e.g., probiotics, constipation medicines including laxatives), health foods, or supplements or who cannot avoid using them. 9.Subjects who were consuming health oils (e.g., coconut oil, MCT oil) that may increase the effects of the food components to be evaluated 4 days or more each week during the past three months or who are consuming such oils. 10.Subjects who are consuming foods rich in components that may affect bowel movements, or foods rich in components that may affect the research area (e.g., yogurt, lactic acid bacteria beverages, fiber- or oligosaccharide-enriched foods, milk, butter, ice cream, cheese, foods rich in milk fat, other fermented foods, granola, prunes) 4 days or more each week. 11.Subjects who are at risk of developing allergic reactions due to the ingredients of the test food's or other factors. 12.Night or shift workers with irregular life patterns. Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 09 Day Date of IRB - 2025 Year 07 Month 11 Day Anticipated trial start date - 2025 Year 08 Month 19 Day Last follow-up date - 2025 Year 12 Month 17 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067077

Disclaimer: Curated by HT Syndication.