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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000026044 |
Receipt No. | R000029853 |
Scientific Title | Suppressive effect of functional rice on the postprandial serum triglyceride level-A randomized, double blind, and cross-over study- |
Date of disclosure of the study information | 2017/02/09 |
Last modified on | 2017/04/27 |
Basic information | ||
Public title | Suppressive effect of functional rice on the postprandial serum triglyceride level-A randomized, double blind, and cross-over study- | |
Acronym | Suppressive effect of functional rice on the postprandial serum triglyceride level | |
Scientific Title | Suppressive effect of functional rice on the postprandial serum triglyceride level-A randomized, double blind, and cross-over study- | |
Scientific Title:Acronym | Suppressive effect of functional rice on the postprandial serum triglyceride level | |
Region |
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Condition | ||
Condition | Healthy subject | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | This study aimed to verify the suppressive effect of functional rice on postprandial serum triglyceride level |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Area under the curve (AUC) of postprandial serum triglyceride level |
Key secondary outcomes | Postprandial serum triglyceride levels and remnant like lipoprotein particle cholesterol levels and their AUC |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
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 | Treatment | |
Type of intervention |
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Interventions/Control_1 | Intake of function rice- wash out- intake of control (Placebo) rice | |
Interventions/Control_2 | Intake of control (placebo) rice- wash out- intake of function rice | |
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) Subjects who have ability to conscent
2)Subjects aged from 20 to less than or equal to 64years old 3)Subjects whose fasting serum triglyceride levels are less than 200 mg/dL |
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Key exclusion criteria | 1) Subjects who have history of serious disease or resection of their gastrointestinal tract.
2) Subjects who routinely use medicine, FOSHU, and/or health food. 3) Subjects who have allergy to test food and/or high fat meal and extreme lactose intolerance or diarrhea. 4) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. 5) Heavy user of alcohol or excessive smoker 6) Subjects who are judged as unsuitable for the study by the investigator for other reason. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Medical Corporation Hokubukai Utsukushigaoka Hospital | ||||||
Division name | Clinical pharmacology center | ||||||
Zip code | |||||||
Address | 61-1 Sin-ei, Kiyota-ku, Sapporo, Hokkaido 004-0839, Japan | ||||||
TEL | 001-882-0111 | ||||||
takano@ughp-cpc.jp |
Public contact | |||||||
Name of contact person |
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Organization | Clinical Support Corporation | ||||||
Division name | Food Division | ||||||
Zip code | |||||||
Address | Minami 1 jou Nishi, Chuo-ku, Sapporo city, Hokkaido, Japan | ||||||
TEL | 011-223-3130 | ||||||
Homepage URL | |||||||
takehara@csc-smo.co.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 | |
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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 | 医療法人北武会 美しが丘病院 |
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 | |||||||
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Date analysis concluded |
Other | |
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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=R000029853 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |