Tokyo, Nov. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059837) titled 'Research on the bioavailability of some functional components after test food intake in healthy subjects' on Nov. 20.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - Kagawa Nutrition University
Condition:
Condition - Healthy adult men
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluating the absorption of some functional components after single intake of test foods
Basic objectives2 - Bio-availability
Intervention:
Interventions/Control_1 - Single intake of test food A > Single intake of test food B > Single intake of test food C
Interventions/Control_2 - Single intake of test food B > Single intake of test food C > Single intake of test food A
Eligibility:
Age-lower limit - 20
years-old
Gender - Male
Key inclusion criteria - (1) Healthy males aged 20 to 74 years
(2) Individuals who voluntarily agree to participate in the clinical trial and are able to provide written informed consent.
(3) Individuals who are able to maintain their usual lifestyle habits consistently throughout the study period.
Key exclusion criteria - 1) Individuals with serious diseases such as diabetes, cardiovascular disease, liver disease, kidney disease, cancer, or psychiatric disorders.
2) Individuals with a history of serious diseases such as diabetes, cardiovascular disease, liver disease, kidney disease, or cancer.
3) Individuals who have donated more than 200 mL of blood in the past month, or more than 400 mL in the past three months.
4) Individuals who have previously experienced discomfort or adverse effects from blood collection, or who have been told that blood collection may be difficult due to small veins.
5) Individuals with severe anemia.
6) Individuals whose dietary intake or physical activity varies significantly, making it difficult to maintain usual lifestyle habits.
7) Individuals with known or suspected food or drug allergies to the test food.
8) Individuals who routinely consume foods with functional claims, health foods, or dietary supplements and are unable to discontinue their intake during the study period.
9) Other individuals deemed ineligible for participation by the principal investigator.
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 19 Day
Date of IRB - 2025 Year 11 Month 19 Day
Anticipated trial start date - 2025 Year 11 Month 20 Day
Last follow-up date - 2026 Year 01 Month 24 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068429
Disclaimer: Curated by HT Syndication.
