Tokyo, Sept. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059067) titled 'Safety evaluation of excessive intake of the test foods containing plant extract' on Sept. 16.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Nippn Corporation
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the safety of excessive intake of the test food containing Plant extract.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Oral intake of the test foods containing plant extract for 4 weeks
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Japanese Men and women between the ages of 20 and 64 at the time of obtaining informed consent
2) Healthy adults
Key exclusion criteria - 1) Participants currently undergoing treatment, taking medication, or visiting a hospital for any disease.
2) Participants who are pregnant, breastfeeding, or who may become pregnant during the study period.
3) Participants who have an alcohol dependence.
4) Participants who are allergic to ingredients related to the test food.
5) Participants who are participating in other clinical studies.
6) Participants who have a history of serious hepatic or kidney damage, heart disorders.
7) Participants with a history of or current hepatitis.
8) Participants with severe anemia.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 10 Day
Anticipated trial start date - 2025 Year 09 Month 16 Day
Last follow-up date - 2025 Year 11 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067044
Disclaimer: Curated by HT Syndication.
