Tokyo, Dec. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059949) titled 'A Safety Study on the Long-Term Ingestion of Dark Chocolate' on Dec. 3.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Hokkaido Information University
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the safety of 16 weeks ingestion of dark chocolate in a randomized, open-label, parallel-group trial.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - No intervention
Interventions/Control_2 - Daily ingestion of chocolate for 16 weeks.
Eligibility:
Age-lower limit - 60
years-old
Gender - Male and Female
Key inclusion criteria - 1. Subjects who were randomized to the no intervention group or the chocolate intervention group among participants of UMIN000054576.
2. Subjects who agree to the secondary use of data collected at UMIN000054576.
Key exclusion criteria - Subjects who did not receive allocated intervention, or who have no data post-randomization.
Target Size - 155
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 27 Day
Date of IRB - 2025 Year 11 Month 27 Day
Anticipated trial start date - 2025 Year 12 Month 26 Day
Last follow-up date - 2026 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068568
Disclaimer: Curated by HT Syndication.
