Tokyo, May 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061610) titled 'Effects of consumption of the test food on the gut microbial metabolites in healthy adults' on May 28.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Fujicco Co., Ltd.
Condition:
Condition - Healthy Japanese subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the effect of consumption of the test food on the gut microbial metabolites in healthy adults
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Daily intake of test food for 2 weeks -> Washout for 3 weeks -> Daily intake of placebo food for 2 weeks
Interventions/Control_2 - Daily intake of placebo food for 2 weeks -> Washout for 3 weeks -> Daily intake of test food for 2 weeks
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Eligibility criteria for participation in the screening:
1) Healthy adults aged 20 years or older
2) Subjects with a bowel movement frequency of at least twice per week
3) Subjects who are receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being to personally sign a written informed consent
Selection criteria in the screening:
1) Subjects who endogenously possess gut microbial metabolite X will be selected for participation in the subsequent intervention study
Key exclusion criteria - 1) Subjects with severe cardiovascular, respiratory, gastrointestinal, urinary, endocrine, or hematological disease
2) Subjects with hypothyroidism
3) Subjects who, at the time of informed consent, are receiving treatment at a medical institution for the treatment or prevention of disease, including hormone therapy, pharmacotherapy, exercise therapy, or diet therapy, or who are judged to be in a condition requiring such treatment
4) Subjects with food or drug allergies
5) Subjects who habitually consume foods for specified health uses, foods with functional claims, supplements, or health foods rich in dietary fiber for the purpose of regulating bowel function or improving the intestinal environment
6) Subjects who consume excessive amounts of alcohol (average weekly alcohol intake exceeding 60 g/day [Reference Materials for Health Japan 21 (the Second Term)])
7) Subjects who are pregnant, breastfeeding, or intending to become pregnant during the study period
8) Subjects who are participating in another clinical study, including a clinical trial
9) Subjects who are judged by the principal investigator to be unsuitable for participation in the study
Target Size - 18
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 08 Month 07 Day
Date of IRB - 2024 Year 08 Month 07 Day
Anticipated trial start date - 2024 Year 11 Month 13 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070488
Disclaimer: Curated by HT Syndication.
