Tokyo, Oct. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063183) titled 'Exploratory Comparative Study on Bioavailability of the Research Food Through Continuous Intake: A Randomized, Open-label, Parallel-group Trial' on Oct. 6.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - IMEQRD Co. Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To exploratorily compare the bioavailability of the research foods after continuous intake.
Basic objectives2 - Bio-availability
Intervention:
Interventions/Control_1 - Intake of the test food for 2 weeks.
Interventions/Control_2 - Intake of the control food for 2 weeks.
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - 1. Men aged 40-59, or postmenopausal women aged 40-59
2. BMI >=18.5 kg/m^2 and <25.0 kg/m^2
3. Provided written informed consent
Key exclusion criteria - 1. Under treatment for any disease, or current or past history of serious disease
2. Allergy to the research food
3. Regular use of health foods or supplements (unless discontinued during the study)
4. Unsuitable for blood sampling, or blood donation/collection exceeding the specified volume within a defined period before the study
5. Participating or planning to participate in another clinical study
6. Otherwise judged unsuitable by the principal investigator
Target Size - 24
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 08 Day
Date of IRB - 2026 Year 09 Month 15 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2026 Year 11 Month 09 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072076
Disclaimer: Curated by HT Syndication.
