Tokyo, July 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062327) titled 'Evaluation Study on Preventive Health Measures Through Improvement of the Gut Microbiome via Consumption of Test Foods' on July 27.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluation of the effectiveness of selecting gut health improvement solutions based on gut microbiota profiles, and assessment of their association with physical condition and health screening parameters
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Test Group 1: A group that consumed low-sugar granola containing prebiotic ingredients tailored to the gut bacteria most prevalent in the individual test subjects
Interventions/Control_2 - Test Group 2: A group that consumed low-sugar granola containing prebiotic ingredients tailored to the gut bacteria least prevalent in the individual test subjects
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1 Individuals who are 20 years of age or older at the time consent is obtained
2 Individuals who reside or work in Kanagawa Prefecture at the time consent is obtained
3 Individuals who can consume granola daily
4 Individuals who can collect stool samples and perform fingerstick blood draws at home and mail them to the designated testing facility
5 Individuals who can independently complete online questionnaires, maintain a lifestyle diary, and update their My ME-BYO Medical Record via a PC or smartphone
6 Individuals who have received a thorough explanation of this study, are able to understand its contents, and can provide their own informed consent
Key exclusion criteria - 1 Individuals who have taken medications that may affect the trial (such as antibiotics, probiotics, or laxatives) within one month prior to Screening 1, or who plan to take such medications during the trial period
2 Individuals who have undergone surgery that is considered likely to affect the trial within six months prior to obtaining informed consent (such as colonoscopy, gallstone or gallbladder removal, or gastric bypass surgery)
3 Individuals who are pregnant, breastfeeding, or intend to become pregnant during the trial period
4 Individuals for whom significant changes in their living environment (e.g., family or work circumstances, such as moving or a job transfer) are anticipated during the trial period
5 Individuals with a history or current diagnosis of liver cancer, inflammatory bowel disease, Crohn's disease, or Parkinson's disease
6 Individuals with allergies to medications or foods
7 Participants who are currently participating in a clinical trial for another pharmaceutical product or dietary supplement, who have done so within the past 4 weeks, or who plan to participate in another clinical trial after providing informed consent for this trial
8 Any other participants deemed unsuitable for this trial by the principal investigator or the trial representative
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 17 Day
Anticipated trial start date - 2026 Year 08 Month 17 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071256
Disclaimer: Curated by HT Syndication.
