Tokyo, Aug. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062490) titled 'Effects of Inulin on the Gut Microbiota-Psychology-Behavior Axis' on Aug. 6.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Waseda University
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to investigate the associations between changes in the gut microbiota following long-term supplementation with the soluble dietary fiber inulin and changes in psychological status, physical activity, and behavioral change. As a secondary objective, changes in cognitive function will also be evaluated.
Basic objectives2 - Bio-availability
Intervention:
Interventions/Control_1 - Inulin (20 g/day) for 8 weeks
(10 g in the morning and 10 g in the evening, dissolved in water)
Interventions/Control_2 - maltodextrin (20 g/day) for 8 weeks
(10 g in the morning and 10 g in the evening, dissolved in water)
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Healthy adutls
Key exclusion criteria - Chronic diseases, Current antibiotic use, History of gastrointestinal diseases
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 06 Day
Anticipated trial start date - 2026 Year 08 Month 06 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071527
Disclaimer: Curated by HT Syndication.
