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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030891
Receipt No. R000035253
Scientific Title An evaluation study of enhancing effect of the absorption of nutrients from carotenoid concentrates by consumption of dairy products
Date of disclosure of the study information 2018/01/20
Last modified on 2018/04/13

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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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