UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038492 |
|---|---|
| Receipt number | R000043067 |
| Scientific Title | Safety trial of oral coadministration of 5-aminolevulinic acid phosphate and Salacia extract |
| Date of disclosure of the study information | 2019/11/05 |
| Last modified on | 2020/11/05 09:33:06 |
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Basic information
Public title
Safety trial of oral coadministration of 5-aminolevulinic acid phosphate and Salacia extract
Acronym
Safety trial of oral coadministration of 5-aminolevulinic acid phosphate and Salacia extract
Scientific Title
Safety trial of oral coadministration of 5-aminolevulinic acid phosphate and Salacia extract
Scientific Title:Acronym
Safety trial of oral coadministration of 5-aminolevulinic acid phosphate and Salacia extract
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of oral coadministration of 5-aminolevulinic acid phosphate and Salacia extract.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse events including laboratory abnormality and the changes in CTCAE grade
Key secondary outcomes
None
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects receive 15 mg/day of 5-aminolevulinic acid phosphate, 1.8 mg/day of Fe, and 0.3 mg/day of salacinol for 12 weeks.
Interventions/Control_2
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy
2) A 75 g Oral glucose tolerance test is <140 mg/dL, or 140<= and <200 mg/dL
3) Willing to provide written informed consent
Key exclusion criteria
1) Taking medicines for chronic disease
2) Taking functional food that may affect the trial
3) Participation in any clinical trial within 90 days of the commencement of the trial
4) In pregnancy or nursing a child
5) Judged as ineligible by clinical investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Higashikawa |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Probiotic Science for Preventive Medicine
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1533
fumiko@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Higashikawa |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Probiotic Science for Preventive Medicine
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1533
Homepage URL
funcfood@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
SBI Pharmaceuticals 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
Human Ethics Review Committee of Hiroshima University
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.ac.jp
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
| 2019 | Year | 11 | Month | 05 | 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
50
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
| 2019 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 05 | Day |
Last modified on
| 2020 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043067
