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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000035493 |
Receipt No. | R000040441 |
Scientific Title | Clinical trial on serum astaxanthin and lutein concentration change by consecutive ingestion of astaxanthin and lutein containing food (self- emulsifying formulation) - a randomized, double-blind, parallel study - |
Date of disclosure of the study information | 2019/11/29 |
Last modified on | 2019/10/30 |
Basic information | ||
Public title | Clinical trial on serum astaxanthin and lutein concentration change by consecutive ingestion of astaxanthin and lutein containing food (self- emulsifying formulation)
- a randomized, double-blind, parallel study - |
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Acronym | Clinical trial on serum astaxanthin and lutein concentration change by consecutive ingestion of astaxanthin and lutein containing food (self- emulsifying formulation) | |
Scientific Title | Clinical trial on serum astaxanthin and lutein concentration change by consecutive ingestion of astaxanthin and lutein containing food (self- emulsifying formulation)
- a randomized, double-blind, parallel study - |
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Scientific Title:Acronym | Clinical trial on serum astaxanthin and lutein concentration change by consecutive ingestion of astaxanthin and lutein containing food (self- emulsifying formulation) | |
Region |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effect of the supplement (astaxanthin and lutein containing food, self- emulsifying formulation) on bioavailability |
Basic objectives2 | Pharmacokinetics |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Blood astaxanthin and lutein concentration change by 3 consecutive weeks ingestion of test food |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | No need to know |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Ingestion of test food for 3 consecutive weeks | |
Interventions/Control_2 | Ingestion of control food for 3 consecutive weeks | |
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 and Female | |||
Key inclusion criteria | 1) Healthy males and females aged from 20 to 50 years old
2) Subjects whose BMI >=18.5 kg/m2 and <25kg/m2 |
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Key exclusion criteria | 1)Subjects who previous serious disease
2)Subjects who have history of surgical resection of the gastrointestinal tract (except for appendectomy) 3)Subjects who have various symptoms of indigestion (diarrhea, stomach feels upset etc.) 4)Subjects who have the habit of skipping breakfast (meals including staple food) 5)Subjects who smoke present or have smoked within the last one year prior to the current study 6)Subjects who have excessive drinking habits 7)Subjects who are taking medicine, being treated by a doctor or are intend to under medication by a doctor during the test period(hay fever etc) 8) Subjects who routinely take medicine or health foods (supplement containing astaxanthin, lutein, other carotenoids, kale juice etc.) that may affect the results of this study 9) Subjects who intend to become pregnant or lactating 10) Subjects who are judged as unsuitable by doctor for other reasons |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | FANCL Corporation | ||||||
Division name | Research Institute | ||||||
Zip code | 244-0806 | ||||||
Address | 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa | ||||||
TEL | 045-820-3532 | ||||||
ke-yui@fancl.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kenkoin Medical Corporation Foundation | ||||||
Division name | Kenkoin Clinic | ||||||
Zip code | 104-0061 | ||||||
Address | 6-7-4 Ginza, Chuo-ku, Tokyo, Japan | ||||||
TEL | 03-3573-1153 | ||||||
Homepage URL | |||||||
reiko-naito@kenkoin.jp |
Sponsor | |
Institute | FANCL Corporation |
Institute | |
Department |
Funding Source | |
Organization | FANCL Corporation |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Research Ethics Committee of Kenkoin Medical Corporation Foundation |
Address | 6-7-4 Ginza, Chuo-ku, Tokyo, Japan |
Tel | 03-3573-1153 |
isamu-yanase@kenkoin.jp |
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 | 医療法人財団健康院 健康院クリニック |
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 |
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Anticipated trial start date |
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Last follow-up date |
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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=R000040441 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |