Tokyo, Oct. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063178) titled 'Effect of Broccoli Sprouts on Intestinal Microbiota and Butyrate Production in Human Healthy Subjects' on Oct. 5.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Tsukuba Gakuen Hospital
Condition:
Condition - Helathy Colon
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effects of dietary approach with sulforaphane-rich broccoli sprouts on butyrate-producing bacteria and butyrate level in colonic luminal environment in human healthy subjects.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Dietary intake of Broccoli Sprouts 50g (220 mg)/day for 4 weeks
Interventions/Control_2 - Dietary intake of Alfalfa Sprouts 50g (0 mg)/day for 4 weeks
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Healthy Subjects with age between 20 and 70
2) Subjects who agree to participate in the study with written informed consent
Key exclusion criteria - Healthy Subjects,
1) who have past or present history of organic intestinal diseases, such as inflammatory bowel diseases and colon tumors.
2) who regularly or ocasionaly take medical drugs or supplements, which may affect composition of intestinal microbiota, such as probiotics, prebiotics, NSAIDs, acid Inhibitors, antibiotics.
2-b) who occasionally, at least more than once, takes medical drugs, which may affect composition of intestinal microbiota, such as probiotics, prebiotics, NSAIDs, Acid Inhibitors, Antibiotics.
3) who did not agree to participate in this study with written informed consent
Target Size - 44
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 04 Month 08 Day
Date of IRB - 2005 Year 05 Month 02 Day
Anticipated trial start date - 2026 Year 10 Month 05 Day
Last follow-up date - 2027 Year 01 Month 24 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072298
Disclaimer: Curated by HT Syndication.