UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058436 |
|---|---|
| Receipt number | R000066770 |
| Scientific Title | Study to confirm absorption of carotenoids in trial foods |
| Date of disclosure of the study information | 2025/07/11 |
| Last modified on | 2025/07/11 11:28:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study to confirm absorption of carotenoids in trial foods
Acronym
Study to confirm absorption of carotenoids in trial foods
Scientific Title
Study to confirm absorption of carotenoids in trial foods
Scientific Title:Acronym
Study to confirm absorption of carotenoids in trial foods
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the absorption effectiveness of existing and new formulations in humans.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC of carotenoid (lutein/zeaxanthin/astaxanthin) concentration in blood
Key secondary outcomes
Blood carotenoid concentrations (lutein/ zeaxanthin/ astaxanthin) at each time point and Cmax
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The trial food will be consumed once, followed by a washout period, then the control food will be consumed once.
Interventions/Control_2
After consuming the control food once, a washout period will follow, and the test food will be consumed once.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 20 to under 60 at the time of informed consent.
2) Participants who with a BMI >=18.5 kg/m2 and <25kg/m2.
3) Participants who received a full explanation of the study and signed the informed consent form before study initiation.
Key exclusion criteria
1) Participants with a history of serious illness or gastrointestinal surgery.
2) Participants with diseases affecting gastric emptying or digestion/absorption, or who regularly experience symptoms such as indigestion, constipation, or diarrhea.
3) Participants with abnormal kidney or liver function, blood pressure, or glucose/lipid metabolism.
4) Participants who regularly use medications (including Kampo), or quasi-drugs or supplements.
5) Participants who regularly consume health foods (e.g., FOSHU, foods with functional claims) that may affect the study and cannot discontinue them during the study period.
6) Participants who consume excessive amounts of alcohol.
7) Participants who Currently smoke or have smoked within the past year.
8) Participants planning to travel abroad during the study period.
9) Participant with irregular work hours or engaged in shift work.
10) Participants who may be unable to maintain their lifestyle due to dietary restrictions.
11) Participants with food allergies or those who may react to the trial or provided food.
12) Participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
13) Participants who joined another clinical trial within one month before consent or plan to join one during the study.
14) Participants deemed ineligible by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Erika |
| Middle name | |
| Last name | Ono |
Organization
FANCL CORPORATION
Division name
Clinical Research Center ,Functional Food Research Institute
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama-shi, Kanagawa, 244-0806, Japan
TEL
045-820-3659
tsubokawa_masaya@fancl.co.jp
Public contact
Name of contact person
| 1st name | Shuka |
| Middle name | |
| Last name | Futagami |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL
03-6777-7789
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
FANCL CORPORATION
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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Otaku, Tokyo, 144-0043, Japan
Tel
03-3741-0223
food-contact@apoplus.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
医療法人社団 渡辺病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 11 | 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
| 2025 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066770
