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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024294 |
Receipt No. | R000027944 |
Scientific Title | Study to confirm the food functionality against the joints and limbs or the like |
Date of disclosure of the study information | 2016/10/04 |
Last modified on | 2017/04/17 |
Basic information | ||
Public title | Study to confirm the food functionality against the joints and limbs or the like | |
Acronym | Study to confirm the food functionality against the joints and limbs or the like | |
Scientific Title | Study to confirm the food functionality against the joints and limbs or the like | |
Scientific Title:Acronym | Study to confirm the food functionality against the joints and limbs or the like | |
Region |
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Condition | ||
Condition | Healthy adult | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the functionality and safety of the test product for the healthy adult men and women with a sense of discomfort in the joints and limbs or the like. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | the questionare for joints and limbs or the like |
Key secondary outcomes | 1.QOL
2.Safety |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 8 weeks , soft capsules containing test food | |
Interventions/Control_2 | ||
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 | 1.20 years of age or older men and women
2.Subjects with a sense of discomfort in the joints and limbs or the like |
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Key exclusion criteria | 1.Subjects who are udergoing treatment which may influence the outcome of the study
2.Subjects who are taking drugs and supplements which may influence the outcome of the st udy 3.Subjects who received the surgery in the past for related the study 4.Subjects who are pregnant or lactating and have these plans 5.Subjects with food allergies 6.Subjects who are judged as unsuitable for the stury by the investigator for the other reason |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Japan clinical trial assosiation | ||||||
Division name | N.A. | ||||||
Zip code | |||||||
Address | 8F, 5-27-3 sendagaya, shibuyaku, Tokyo | ||||||
TEL | 03-6457-4666 | ||||||
info@yakujihou.org |
Public contact | |||||||
Name of contact person |
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Organization | Japan clinical trial assosiation | ||||||
Division name | N.A. | ||||||
Zip code | |||||||
Address | 8F, 5-27-3 sendagaya, shibuyaku, Tokyo | ||||||
TEL | 03-6457-4666 | ||||||
Homepage URL | |||||||
info@yakujihou.org |
Sponsor | |
Institute | Japan clinical trial assosiation |
Institute | |
Department |
Funding Source | |
Organization | Ajinomoto Co., Inc. |
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=R000027944 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |