Tokyo, April 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061141) titled 'A study on blood component measurements after consumption of the test food' on April 2.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Active
Primary Sponsor:
Institute - Life Science Division Fuji Chemical Industries Co., Ltd.
Condition:
Condition - Healthy Japanese
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the time-dependent changes in blood astaxanthin compounds after consumption of the test food.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 -
Single ingestion
Test 1: Test food 1
Test 2: Test food 2
*The intervention sequence is Test 1 followed by Test 2.
*The washout period is at least one week.
Interventions/Control_2 -
Single ingestion
Test 1: Test food 2
Test 2: Test food 1
*The intervention sequence is test 1 followed by test 2.
*The washout period is at least one week.
Eligibility:
Age-lower limit - 18
years-old
=18.5 kg/m2 and <25 kg/m2
Key exclusion criteria - 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator
3. Individuals who are currently receiving treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, chronic kidney disease, cerebrovascular disease, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic disease
4. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims
5. Individuals who are taking or using medications (including herbal medicines) or supplements
6. Individuals who are allergic to medications or foods related to the test food
7. Individuals who are pregnant, lactating, or planning pregnancy during this study
8. Individuals who have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study
9. Individuals who have pre-existing gastrointestinal diseases (irritable bowel syndrome, inflammatory bowel disease, gastric ulcer, or gastroesophageal reflux disease)
10. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Target Size - 9
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 03 Month 11 Day
Date of IRB - 2026 Year 03 Month 11 Day
Anticipated trial start date - 2026 Year 04 Month 02 Day
Last follow-up date - 2026 Year 06 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069962
Disclaimer: Curated by HT Syndication.