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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000030836 |
Receipt No. | R000035198 |
Scientific Title | A study of excessive intake of the food ingredient (SME-2017-08-HRCT) |
Date of disclosure of the study information | 2018/01/21 |
Last modified on | 2018/07/19 |
Basic information | ||
Public title | A study of excessive intake of the food ingredient
(SME-2017-08-HRCT) |
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Acronym | A study of excessive intake of the food ingredient | |
Scientific Title | A study of excessive intake of the food ingredient
(SME-2017-08-HRCT) |
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Scientific Title:Acronym | A study of excessive intake of the food ingredient | |
Region |
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Condition | ||
Condition | Not applicable | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the safety of food |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Incidence of side effects |
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 | 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 | Four weeks repeated intake of the test foods | |
Interventions/Control_2 | Four weeks repeated intake of the control foods | |
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)Males and females whose age are 20<= years old
2)Subjects who are able to submit the written informed consents |
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Key exclusion criteria | 1)Subjects who are with treatment
2)Females in pregnancy, lactation and scheduled pregnancy period 3)Subjects who are attending other studies or attended other studies within the past 4 weeks 4)Subjects who are; a)With present heart disorder, liver disorder, or kidney disorder, b)With history of cardiac disorder, c)With diabetes mellitus, or d)With allergy to the study foods 5)Subjects who habitually intake drugs, foods for specified health uses (FOSHU), functional foods, or dietary supplements 6)Subjects who are deemed to be unsuitable by the investigator |
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Target sample size | 48 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Suntory MONOZUKURI Expert Limited | ||||||
Division name | R&D Support Department HE Center | ||||||
Zip code | |||||||
Address | 2-3-3 Daiba, Minato-ku, Tokyo, Japan | ||||||
TEL | 03-5579-1277 | ||||||
Junichi_Nakamura@suntory.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Suntory MONOZUKURI Expert Limited | ||||||
Division name | R&D Support Department HE Center | ||||||
Zip code | |||||||
Address | 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan | ||||||
TEL | 050-3182-0527 | ||||||
Homepage URL | |||||||
Kayo_Saito@suntory.co.jp |
Sponsor | |
Institute | Suntory MONOZUKURI Expert Limited |
Institute | |
Department |
Funding Source | |
Organization | Suntory Wellness Limited |
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=R000035198 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |