Tokyo, Nov. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059806) titled 'A measurement study of blood lipid components concentration at the time of test food consumption' on Nov. 18.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Active

Primary Sponsor: Institute - Raffinee International Inc.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To measure blood components of test product consumption. Basic objectives2 - Bio-equivalence

Intervention: Interventions/Control_1 - Single ingestion

Test 1: Food 1 Test 2: Food 2 *Test 1 followed by Test 2. *The washout period is at least one week. Interventions/Control_2 - Single ingestion

Test 1: Food 2 Test 2: Food 1 *Test 1 followed by Test 2. *The washout period is at least one week.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults

4. Healthy individuals Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking or using medicines (including herbal medicines) or supplements

6. Individuals with allergies (related to pharmaceuticals, test products, or food), particularly with allergies to gelatin, wheat, soybeans, chicken, sesame, pork, or apples

7. Individuals who are pregnant, lactating, or planning to become pregnant during this study

8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

9. Individuals who are judged as ineligible to participate in this study by the physician

10. Individuals who cannot regularly take three meals (breakfast, lunch, and dinner) a day

11. Individuals who take dairy products such as milk and cheese at least four times a week

12. Individuals who are restricting their diet or exercising for the purpose of dieting Target Size - 10

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 12 Day Date of IRB - 2025 Year 11 Month 12 Day Anticipated trial start date - 2025 Year 11 Month 18 Day Last follow-up date - 2026 Year 02 Month 02 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068387

Disclaimer: Curated by HT Syndication.