UMIN-CTR Clinical Trial

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
Email	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
Email	funcfood@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043067