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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028316
Receipt No. R000032315
Scientific Title Safety of Overconsumption of a Food Containing of Plant Extract
Date of disclosure of the study information 2017/07/24
Last modified on 2017/12/14

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Basic information
Public title Safety of Overconsumption of a Food Containing of Plant Extract
Acronym Safety of Overconsumption of a Food Containing of Plant Extract
Scientific Title Safety of Overconsumption of a Food Containing of Plant Extract
Scientific Title:Acronym Safety of Overconsumption of a Food Containing of Plant Extract
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examines safety of overconsumption (4 weeks) of a food containing of 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: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed) (SCR, Week 0, Week 2, Week 4)
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 2, Week 4)
[2]Blood pressure, pulsation (SCR, Week 0, Week 2, Week 4)
[3]Weight, body fat percentage, BMI (SCR, Week 0, Week 2, Week 4)
[4]Hematologic test (SCR, Week 0, Week 2, Week 4)
[5]Blood biochemical test (SCR, Week 0, Week 2, Week 4)
[6]Urine analysis (SCR, Week 0, Week 2, Week 4)
[7]Doctor's questions (SCR, Week 0, Week 2, Week 4)

*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
Food
Interventions/Control_1 Oral intake of the test product (containing plant extract; 300mL in a day for 4 weeks)
Interventions/Control_2 Oral intake of the placebo product (not containing plant extract; 300mL in a day for 4 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
20 years-old <=
Age-upper limit
65 years-old >=
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.
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.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Sugimoto
Organization Otsubokai Medical Corporation Tohto Bunkyo Hospital
Division name Head
Zip code
Address 3-5-7 Yushima Bunkyo-ku Tokyo 113-0034, JAPAN
TEL +81-3-3831-2181
Email info@tes-h.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoma Shimizu
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
Email 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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 07 Month 24 Day

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
2017 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 30 Day
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
2017 Year 07 Month 21 Day
Last modified on
2017 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032315

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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