Tokyo, Nov. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059779) titled 'Research on the long-term consumption of dietary fiber-containing food' on Nov. 25.

Study Type: Interventional

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

Primary Sponsor: Institute - EP Mediate Co., Ltd.

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

Objective: Narrative objectives1 - Safety assessment of long-term consumption of dietary fiber-containing food. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Continuous intake of test food for 12 weeks Interventions/Control_2 - Continuous intake of placebo for 12 weeks

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - (1) Male and female aged 20 to 64 (2) Subjects who have a bowel movement frequency of more than 6 times/week or between 3 and 5 times/week (3) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study Key exclusion criteria - (1) Subjects who take health foods related to the test food more than 1 day a week (2) Subjects who habitually take health foods or pharmaceuticals that are expected to have effects that overlap with the product concept (3) Subjects with a medical condition that may affect the study (4) Subjects who are diagnosed by a doctor with constipation or irritable bowel syndrome, currently. (5) Subjects who have had abnormalities in clinical test values or cardiopulmonary function and are judged to be unsuitable for participation in the study (6) Subjects who are at risk of developing allergies related to the study (7) Subjects with a disease requiring regular medication, with a disease currently being treated (excluding dry eyes and tooth decay) or with a history of a serious disease that required medication (8) Subjects whose pre-intake test results are significantly outside the reference range (9) Subjects who work in shifts, late-night shifts, or have other irregular lifestyles (10) Subjects who have participated or plan to participate in other studies within one month of the start of the study or during the study (11) Females who are pregnant, potentially pregnant (only to wish to become pregnant during the study period), or breastfeeding (12) Subjects who are judged to be unsuitable for participation in the study based on their responses to the lifestyle questionnaire or pre-intake test results (13) Subjects who are judged as unsuitable for the study by the investigator for other reason Target Size - 48

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 23 Day Date of IRB - 2025 Year 10 Month 23 Day Anticipated trial start date - 2025 Year 11 Month 25 Day Last follow-up date - 2026 Year 05 Month 08 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068341

Disclaimer: Curated by HT Syndication.