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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043010
Receipt No. 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

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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
Email 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
Email masashi.morifuji@meiji.com

Sponsor
Institute Meiji Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049103

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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