UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016582 |
|---|---|
| Receipt number | R000019238 |
| Scientific Title | Phase I clinical safety study of Enzyme-treated Asparagus Extract (ETAS) by the healthy subjects (a randomized placebo-controlled trial) |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2015/11/26 11:30:53 |
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Basic information
Public title
Phase I clinical safety study of Enzyme-treated Asparagus Extract (ETAS) by the healthy subjects (a randomized placebo-controlled trial)
Acronym
The phase I safety study of Enzyme-treated Asparagus Extract (ETAS)
Scientific Title
Phase I clinical safety study of Enzyme-treated Asparagus Extract (ETAS) by the healthy subjects (a randomized placebo-controlled trial)
Scientific Title:Acronym
The phase I safety study of Enzyme-treated Asparagus Extract (ETAS)
Region
| Japan |
Condition
Condition
Healthy Volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety of a novel anti-stresss functional foods Enzyme-treated Asparagus Extract(ETAS)is evaluated by randomized placebo-controlled trial with the healthy subjects
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
The clinical efficacy (blood cortisol and Heat Shock Protein 70(HSP70) expression level)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Group A(ETAS capsule)
Interventions/Control_2
Group B(placebo capsule)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The subjects who are not the patients without drug treatments
2) Possible to orally supprementation.
4) the age is over 20 years old
3) Satisfy the following items of pre-screening exams.
- Leukocyte counts: > 3,000 /mm3 and < 12,000 /mm3
- Platelet conuts: > 100,000 /mm3
- HbA1c: <6.5 (JDS) or <6.9 (NGSP)
- Serum AST and ALT: under 2.5 times of the criterion in this hospital
- Serum creatinin: < 2.5 mg/dL
- e-GFR (MDRD): > 30 ml/min/1.73 m2
5) the subjects who signed consent form
Key exclusion criteria
1) Severe clinical history
2) Pregnancy or the subjects to desire it.
3) Lactation period
4) The subject who cannot measure the body composition by bioelectrical impedance analysis because of equipment of medical machine such as pacemaker or severe dry skin.
5) The case that the doctor judged to be unsuitable for the participation of this examination
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Maeda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Integrative Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
+81668793498
kaz@cam.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asuka Yasueda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Integrative Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
+81668793498
Homepage URL
a-yasueda@cam.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Department of Integrative Medicine
Institute
Department
Personal name
Funding Source
Organization
Amino Up Chemical Co. Ltd.
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
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
大阪大学医学部附属病院未来医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 01 | 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
Severe side effects associated with taking formulation were not observed.
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
| 2015 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 19 | Day |
Last modified on
| 2015 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019238
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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