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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034840
Receipt No. R000039192
Scientific Title An evaluation of the change of plasma lutein concentration after the co-ingestion of dairy products and vegetables in human subjects
Date of disclosure of the study information 2018/11/11
Last modified on 2019/05/13

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Basic information
Public title An evaluation of the change of plasma lutein 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 lutein 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 lutein concentration
Key secondary outcomes Plasma beta-carotene, retinyl palmitate concentration

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
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
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 18092006
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
2018 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/ctr_e/ctr_view.cgi?recptno=R000039192

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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