Tokyo, Nov. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059853) titled 'A study on blood beta-carotene kinetics after consumption of the test food: a randomized, double-blind, active-controlled, crossover comparison study' on Nov. 21.

Study Type: Interventional

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

Primary Sponsor: Institute - Yakult Health Foods Co., Ltd.

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

Objective: Narrative objectives1 - To observe blood beta-carotene kinetics after oral consumption of green juice products manufactured by different processes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Two single ingestions

Screening: Green juice powder B Test 1: Green juice powder A Test 2: Green juice powder B

Dissolve two packets (8 g) in 200 mL of water and consume.

*Test 1 followed by Test 2. *The washout period is one week or more. Interventions/Control_2 - Two single ingestions

Screening: Green juice powder B Test 1: Green juice powder B Test 2: Green juice powder A

Dissolve two packets (8 g) in 200 mL of water and consume.

*Test 1 followed by Test 2. *The washout period is one week or more.

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

5. Individuals whose BMI is < 30 kg/m2 at screening

6. Individuals whose blood beta-carotene level three hours after the consumption of the control product at screening is higher than before consumption 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, particularly those who regularly take beta-carotene, vitamin A, or multivitamins

6. Individuals who are allergic to medicines or foods related to the test product, particularly wheat, milk, beef, soy, chicken, banana, pork, or apple

7. Individuals who regularly consume vegetables, fruits, yogurt, or other similar foods

8. Individuals who regularly consume alcohol in excess (averaging more than about 20 g of pure alcohol per day) {e.g., 500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}

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

10. 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

11. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 12

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 21 Day Last follow-up date - 2026 Year 03 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068444

Disclaimer: Curated by HT Syndication.