Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000046208) titled 'Blood dynamics test by ingestion of test food' on Dec. 31.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Nitta Gelatin Inc.
Research Department
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To elucidate the transition to blood by measuring the amount of active ingredient in venous plasma after ingestion of test food.
Basic objectives2 - Bio-availability
Intervention:
Interventions/Control_1 - Duration: once/day
Test food: A
Administration: From 20:00 on the previous day until the final blood sampling on the day of the test, the patient was fasted and ingested 5 g of test food A at a time.
Interventions/Control_2 - Duration: once/day
Test food: B
Administration: From 20:00 on the previous day until the final blood sampling on the day of the test, the patient was fasted and ingested 5 g of test food B at a time.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Healthy men and women between the ages of 20 and 70.
2) A person who receives all explanations, agrees, and is expected to be able to complete it.
Key exclusion criteria - 1) Pregnant / lactating
2) Those who are prone to anemia
3) Those who are continuously receiving medical treatment or medication for illness, etc.
4) Those with a history of cardiovascular disease or renal function
5) Those with nervous system diseases and metabolic disorders
6) In addition, those who are judged by the investigator to be non-conforming
7) Those who are taking medications other than the above that may affect the test results
8) Those who have already participated in other clinical trials
9) Those who take collagen every day
Target Size - 6
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2021 Year 10 Month 15 Day
Date of IRB - 2021 Year 11 Month 18 Day
Anticipated trial start date - 2021 Year 11 Month 19 Day
Last follow-up date - 2022 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052736
Disclaimer: Curated by HT Syndication.
