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UMIN-CTR Clinical Trial |
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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 |
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 | |
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Condition | |||
Condition | Healthy subjects | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |