Tokyo, Oct. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063259) titled 'Comparison of carotenoid absorption from fresh vegetables and vegetable juice without added lipids' on Oct. 14.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - KAGOME CO., LTD.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to demonstrate that carotenoid absorption is higher from vegetable juice than from fresh vegetables, even in the absence of added lipids, thereby demonstrating the potential usefulness of vegetable juice.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Consumption of fresh vegetables (tomato and carrot)
Interventions/Control_2 - Consumption of vegetable juice (tomato juice and carrot juice)
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Japanese male and female participants aged >= 18 and =25
Individuals with elevated blood lipids (triglycerides >=150 mg/dL or LDL cholesterol >=140 mg/dL)
Individuals with a history of major gastrointestinal surgery (except appendectomy)
Individuals receiving medical treatment or taking medication (excluding topical agents such as eye, nasal drops, and ointments)
Individuals who are pregnant, breastfeeding, or plan to become pregnant during the study
Individuals with food allergies or unable to consume the entire test food portion
Current smokers or individuals who smoked within the past 6 months
Individuals with irregular lifestyles, including shift or night-shift workers
Individuals who do not regularly eat three meals a day
Individuals who regularly consume carotenoid supplements, vegetable juice, or vegetable-fruit juice (>=3 times/week)
Individuals with difficult venous access
Individuals who participated in another human study within the past month or plan to participate in another study after providing informed consent for this study
Individuals who donated blood by apheresis or donated 200 mL of whole blood within 1 month before study initiation
Male individuals who donated 400 mL of whole blood within 3 months before study initiation
Female individuals who donated 400 mL of whole blood within 4 months before study initiation
Male individuals whose total blood donation volume in the 12 months before study initiation, including the planned collection for this study, would exceed 1,200 mL
Female individuals whose total blood donation volume in the 12 months before study initiation, including the planned collection for this study, would exceed 800 mL
Individuals deemed ineligible by the principal investigator
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 10 Month 09 Day
Date of IRB - 2026 Year 10 Month 09 Day
Anticipated trial start date - 2026 Year 10 Month 16 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072409
Disclaimer: Curated by HT Syndication.