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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028315 |
Receipt No. | R000032314 |
Scientific Title | Safety Evaluation of Long-Term Intake of a Test Food Containing Plant Extract |
Date of disclosure of the study information | 2017/07/21 |
Last modified on | 2017/12/14 |
Basic information | ||
Public title | Safety Evaluation of Long-Term Intake of a Test Food Containing Plant Extract | |
Acronym | Safety Evaluation of Long-Term Intake of a Test Food Containing Plant Extract | |
Scientific Title | Safety Evaluation of Long-Term Intake of a Test Food Containing Plant Extract | |
Scientific Title:Acronym | Safety Evaluation of Long-Term Intake of a Test Food Containing Plant Extract | |
Region |
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Condition | ||
Condition | N/A(healthy adults) | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | This study examines safety of long-term intake (12 weeks) of a test food containing plant extract. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | [1]Existence and its contents of side effects: number of cases and expression rate of side effects (expression rate: number of cases/number of cases analyzed) (SCR, Week 0, Week 4, Week 8, Week 12) |
Key secondary outcomes | *Secondary outcomes
[1]Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (SCR, Week 0, Week 4, Week 8, Week 12) [2]Blood pressure, pulsation (SCR, Week 0, Week 4, Week 8, Week 12) [3]Weight, body fat percentage, BMI (SCR, Week 0, Week 4, Week 8, Week 12) [4]Hematologic test (SCR, Week 0, Week 4, Week 8, Week 12) [5]Blood biochemical test (SCR, Week 0, Week 4, Week 8, Week 12) [6]Urine analysis (SCR, Week 0, Week 4, Week 8, Week 12) [7]Doctor's questions (SCR, Week 0, Week 4, Week 8, Week 12) *Other index [1]Subject's diary (each day during the test period) |
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 | Treatment | |
Type of intervention |
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Interventions/Control_1 | Oral intake of the test product (containing plant extract; 100mL in a day for 12 weeks) | |
Interventions/Control_2 | Oral intake of the placebo product (not containing plant extract; 100mL in a day for 12 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]Japanese males and females aged 20-65 years (estimated male-female rate of subjects is 1:1; the generation variability of subjects shall be avoided).
[2]Individuals whose BMI is over 18.5 and under 30. [3]Individuals who are healthy and are not suffered from a chronic malady. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can come to the designated venue for this study and be inspected. [6]Individuals judged appropriate for the study by the principal. |
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Key exclusion criteria | [1]Individuals using medical products.
[2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [5]Individuals who are a patient or have a history of or endocrine disease. [6]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [7]Individuals who experienced unpleasant feeling during blood drawing. [8]Individuals who are sensitive to a test product or other foods, and medical products. [9]Individuals who habitually take the foods for specified health uses (FOSHU) or functional food. (Except for subjects who can stop consume them after informed consent). [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [11]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [12]Individuals who are or are possibly, or are lactating. [13]Individuals who participated in other clinical studies in the past 3 months. [14]Individuals who are or whose family is engaged in healthy or functional foods. [15]Individuals judged inappropriate for the study by the principal. |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch | ||||||
Division name | Head of center | ||||||
Zip code | |||||||
Address | 1-20-11 Ueno Taito-ku Tokyo 110-0005, JAPAN | ||||||
TEL | +81-3-5816-0711 | ||||||
info@tes-h.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | TES Holdings Co., Ltd | ||||||
Division name | Administrative Department of Clinical Trials | ||||||
Zip code | |||||||
Address | 6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN | ||||||
TEL | +81-3-6801-8480 | ||||||
Homepage URL | |||||||
r.shimizu@tes-h.co.jp |
Sponsor | |
Institute | TES Holdings Co., Ltd |
Institute | |
Department |
Funding Source | |
Organization | Ogawa & Co., Ltd |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
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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 |
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 | |
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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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Anticipated trial start 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=R000032314 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |