UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030891 |
|---|---|
| Receipt number | 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 08:49:54 |
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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
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
tomoyuki.fukasawa@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035253
