UMIN-CTR Clinical Trial

Basic information
Public title	An evaluation study of enhancing effect of the absorption of nutrients from carotenoid concentrates by consumption of dairy products
Acronym	An evaluation study of enhancing effect of the absorption of nutrients from carotenoid concentrates by consumption of dairy products
Scientific Title	An evaluation study of enhancing effect of the absorption of nutrients from carotenoid concentrates by consumption of dairy products
Scientific Title:Acronym	An evaluation study of enhancing effect of the absorption of nutrients from carotenoid concentrates by consumption of dairy products
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the enhancing effect of the absorption of nutrients by consumption of dairy products
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma beta-carotene level
Key secondary outcomes	Plasma lycopene, lutein, alpha-carotene, zeaxanthin levels

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 consume the active food once a day. After the washout period (from 13 days to 20 days), subjects consume the placebo food once a day.
Interventions/Control_2	Subjects consume the placebo food once a day. After the washout period (from 13 days to 20 days), subjects consume the active food once a day.
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, food for specified health uses, supplements containing carotenoids more than two days per week, or during this study period 2)Subjects who have chronic diseases and administer treatments and 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 operated digestive surgical. 7) Subjects who habitually smoke within a month 8) Subjects who participated in other clinical trials within a month or plan to participate other clinical trials during this study period 9) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukio Asami
Organization	Meiji Co., Ltd.
Division name	Food Microbiology Research Laboratories, R&D Division
Zip code
Address	1-29-1 Nanakuni, Hachiouji, Tokyo
TEL	042-632-5822
Email	yukio.asami@meiji.com

Public contact
Name of contact person	1st name Middle name Last name Tomoyuki Fukasawa
Organization	Meiji Co., Ltd.
Division name	Food Microbiology Research Laboratories, R&D Division
Zip code
Address	1-29-1 Nanakuni, Hachiouji, Tokyo
TEL	042-632-5822
Homepage URL
Email	tomoyuki.fukasawa@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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 20 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	2017 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date	2018 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 19 Day
Last modified on	2018 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035253

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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