UMIN-CTR Clinical Trial

Basic information
Public title	An evaluation of the change of plasma lycopene concentration after the co-ingestion of dairy products and vegetables in human subjects
Acronym	An evaluation of the change of plasma carotenoid concentration after the co-ingestion of dairy products and vegetables
Scientific Title	An evaluation of the change of plasma lycopene concentration after the co-ingestion of dairy products and vegetables in human subjects
Scientific Title:Acronym	An evaluation of the change of plasma carotenoid concentration after the co-ingestion of dairy products and vegetables
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 dairy products and vegetables
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma lycopene concentration
Key secondary outcomes

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects receive a single dose of the active food. After the washout period (from 13 days to 20 days), subjects receive a single dose of the placebo food.
Interventions/Control_2	Subjects receive a single dose of the placebo food. After the washout period (from 13 days to 20 days), subjects receive a single dose of the active food.
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	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	16

Research contact person
Last 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	042-632-5822
Email	yukio.asami@meiji.com

Public contact
1st 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	042-632-5822
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	18092005
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	2018 Year 11 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	16
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	2018 Year 09 Month 20 Day
Date of IRB	2019 Year 09 Month 20 Day
Anticipated trial start date	2018 Year 11 Month 11 Day
Last follow-up date	2019 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 09 Day
Last modified on	2019 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039191