UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063259 |
|---|---|
| Receipt number | R000072409 |
| Scientific Title | Comparison of carotenoid absorption from fresh vegetables and vegetable juice without added lipids: open-label crossover study |
| Date of disclosure of the study information | 2026/10/14 |
| Last modified on | 2026/10/13 17:41:02 |
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Basic information
Public title
Comparison of carotenoid absorption from fresh vegetables and vegetable juice without added lipids
Acronym
Comparison of carotenoid absorption from fresh vegetables and vegetable juice
Scientific Title
Comparison of carotenoid absorption from fresh vegetables and vegetable juice without added lipids: open-label crossover study
Scientific Title:Acronym
Comparison of carotenoid absorption from fresh vegetables and vegetable juice
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Carotenoid absorption
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC and incremental AUC of lycopene or beta-carotene concentrations in the blood TRL fraction from 0 to 9 hours after test food intakes
Key secondary outcomes
Changes in lycopene, beta-carotene, alpha-carotene, and their combined concentrations in the blood TRL fraction at 0, 2, 4, 6, and 9 hours after test food intakes
AUC and incremental AUC of lycopene , beta-carotene, alpha-carotene , and their combined concentrations in the blood TRL fraction from 0 to 9 hours after test food intakes, excluding items that overlap with the primary endpoints of both Study 1 and Study 2
Questionnaires on test food
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of fresh vegetables (tomato and carrot)
Interventions/Control_2
Consumption of vegetable juice (tomato juice and carrot juice)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese male and female participants aged >= 18 and < 50 years, who do not meet any exclusion criteria, express willingness to participate in the study, and provide informed consent online
Key exclusion criteria
Individuals with a BMI <18.5 or >=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 sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Waki |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Naoko_Waki@kagome.co.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Tsukamoto |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KAGOME CO.,LTD. Research Ethics Review Committee
Address
Nihonbashi Hamacho F Tower, 3-21-1 Nihonbashi Hamacho, Chuo-ku, Tokyo, Japan
Tel
03-5623-8501
IRB@kagome.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 13 | Day |
Last modified on
| 2026 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072409
