Tokyo, May 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061688) titled 'A study to evaluate the effects of regular consumption of a test product on glycemic-related parameters' on May 26.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - KAGOME CO., LTD.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to demonstrate that regular consumption of a test product does not worsen glycemic-related parameters compared with placebo, thereby supporting increased consumption of a test product.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Consumption of the test product for 24 weeks
Interventions/Control_2 - Consumption of the placebo for 24 weeks
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Japanese male and female participants aged >= 18 and = 200 mL within the past month or >= 400 mL within the past three months
8. Individuals with chronic diseases requiring daily medication
9. Individuals diagnosed with liver cirrhosis or chronic hepatitis B or C
10. Individuals with a history of gastrointestinal surgery (e.g., gastrectomy or bypass surgery)
11. Individuals unable to maintain a stable daily routine, such as those working exclusively night shifts or extreme shift schedules
12. Individuals participating in other clinical studies at the start of this study
13. Individuals deemed unsuitable by the principal investigator or sub-investigator
Target Size - 112
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 22 Day
Date of IRB - 2026 Year 05 Month 13 Day
Anticipated trial start date - 2026 Year 06 Month 24 Day
Last follow-up date - 2027 Year 04 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070527
Disclaimer: Curated by HT Syndication.
