UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043010 |
|---|---|
| Receipt number | R000049103 |
| Scientific Title | An evaluation of the change of plasma carotenoid concentration after the co-ingestion of sterilized fermented milk and vegetables in human subjects. |
| Date of disclosure of the study information | 2021/01/16 |
| Last modified on | 2021/07/19 10:39:15 |
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Basic information
Public title
An evaluation of the change of plasma carotenoid concentration after the co-ingestion of sterilized fermented milk and vegetables in human subjects.
Acronym
An evaluation of the change of plasma carotenoid concentration after the co-ingestion of sterilized fermented milk and vegetables in human subjects.
Scientific Title
An evaluation of the change of plasma carotenoid concentration after the co-ingestion of sterilized fermented milk and vegetables in human subjects.
Scientific Title:Acronym
An evaluation of the change of plasma carotenoid concentration after the co-ingestion of sterilized fermented milk and vegetables in human subjects.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the change of plasma carotenoid concentration after the co-ingestion of sterilized fermented milk and vegetables.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma beta-carotene concentration (TRL fraction)
Key secondary outcomes
Plasma alpha-carotene, lycopene, lutein, zeaxanthin, beta-cryptoxanthin, total carotenoid and retinyl palmitate concentration (TRL fraction).
Plasma beta-carotene, alpha-carotene, lycopene, lutein, zeaxanthin, beta-cryptoxanthin, total carotenoid and retinyl palmitate concentration (All fraction).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects receive a single dose of the placebo food. After the washout period (13 days or more), subjects receive a single dose of the active food (low dose). After the washout period (13 days or more), subjects receive a single dose of the active food high dose).
Interventions/Control_2
Subjects receive a single dose of the active food (low dose). After the washout period (13 days or more), subjects receive a single dose of the active food (high dose). After the washout period (13 days or more), subjects receive a single dose of the placebo food.
Interventions/Control_3
Subjects receive a single dose of the active food (high dose). After the washout period (13 days or more), subjects receive a single dose of the placebo food. After the washout period (13 days or more), subjects receive a single dose of the active food (low dose).
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Subjects giving written informed consent
2) Males aged 20 to 35 years old when consent acquisition
3) Subjects whose body mass index (BMI) is from 18.5 kg/m2 to 25.0 kg/m2
Key exclusion criteria
1) Subjects who routinely use pharmaceuticals, quasi-drugs, dietary supplement, and consume food for specified health uses, supplements containing carotenoids more than two days per week
2) Subjects who have chronic diseases necessitating treatments and/or medications
3) Subjects who have abnormal lipid metabolism, glucose metabolism, liver function, or kidney function
4) Subjects who have food allergy
5) Subjects who have lactose intolerance
6) Subjects who received digestive surgical procedures
7) Subjects who are habitual smokers within a month of study enrollment
8) Subjects who donate 200 mL of blood within a month, or 400 mL of blood within three month
9) Subjects who participate in other clinical trials within the past month or have plans to participate in other clinical trials during this study period
10) Subjects who determine ineligible by the principal investigator or sub-investigator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Asami |
Organization
Meiji Co., Ltd.
Division name
Food Microbiology Research Laboratories, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo
TEL
042-632-5838
yukio.asami@meiji.com
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Morifuji |
Organization
Meiji Co., Ltd
Division name
Food Microbiology Research Laboratories, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo
TEL
042-632-5838
Homepage URL
masashi.morifuji@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachiouji, Tokyo
Tel
042-632-5900
MEIJI.IRB@meiji.com
Secondary IDs
Secondary IDs
YES
Study ID_1
20112001
Org. issuing International ID_1
CPCC Institutional Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 16 | 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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049103
