Clinical Trial: Study on Improvement of Intestinal Environment and Defecation by Intake of beet (Randomized Crossover Trial) (Japan)

Tokyo, Jan. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060310) titled 'Study on Improvement of Intestinal Environment and Defecation by Intake of beet (Randomized Crossover Trial)' on Jan. 9.

Study Type: Interventional

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

Primary Sponsor: Institute - Wayo Women's University

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

Objective: Narrative objectives1 - The purpose of this study is to conduct a randomized crossover trial to examine the effect of beetroot powder intake on bowel movements associated with changes in intestinal bacteria in healthy adult men and women. Basic objectives2 - Bio-availability

Intervention: Interventions/Control_1 - 1.Test period is 11 weeks. 2.Observation period(1 week)->Test food intake period(4 weeks)->Washout period(2 weeks)->Placebo food intake period(4 weeks) 3.Test food contained beet powder. Interventions/Control_2 - 1.Test period is 11 weeks. 2.Observation period(1 week)->Placebo food intake period(4 weeks)->Washout period(2 weeks)->Test food intake period(4 weeks) 3.Test food contained beet powder.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1.Healthy adult men and women 2.Subjects who have 3 to 5 bowel movements per week or those who have difficulty defecating or a feeling of incomplete bowel movements Key exclusion criteria - 1.Subjects with a history of digestive disorders or gastrointestinal surgery 2.Subjects who regularly use intestinal regulators or laxatives (including laxatives) 3.Subjects who are unable to stop excessive intake of foods containing live bacteria such as lactic acid bacteria, bifidobacteria, and natto bacteria, including 'Food for Specified Health Uses' and 'Foods with Functional Claims', during the study period 4.Subjects who are pregnant or willing to be pregnant or breast-feeding during this study 5.Subjects who are allergic to nuts (almonds) Target Size - 20

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 12 Month 15 Day Date of IRB - 2025 Year 12 Month 19 Day Anticipated trial start date - 2025 Year 12 Month 23 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068990

Disclaimer: Curated by HT Syndication.