UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000049103