Tokyo, Oct. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063344) titled 'The Effects of Continuous Consumption of the Test Food on Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial' on Oct. 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - IMEQRD Co. Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This trial aims to evaluate the effects of consuming the test food continuously for 12 weeks on immune parameters in Japanese men and women aged 20 to
Gender - Male and Female
Key inclusion criteria - 1. Aged 20 to =18.5 and =40 g/day).
15. Heavy smoking (>=21 cigarettes/day).
16. Shift work including night shifts.
17. Planned major lifestyle changes (diet, sleep, or exercise) during the study.
18. Planned overseas travel during the study.
19. Pregnancy, lactation, or planned pregnancy.
20. Blood donation of 200 mL within 1 month before consent or 400 mL within 3 months before study start.
21. Participation in another clinical study within 1 month before consent, current participation, or planned participation during this study.
22. Deemed unsuitable by the principal investigator.
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 18 Day
Date of IRB - 2026 Year 08 Month 25 Day
Anticipated trial start date - 2027 Year 01 Month 26 Day
Last follow-up date - 2027 Year 04 Month 22 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072479
Disclaimer: Curated by HT Syndication.
