UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037230 |
|---|---|
| Receipt number | R000040970 |
| Scientific Title | Safety evaluation of an excessive consumption of a plant-derived functional substance . a randomized, double-blind, placebo-controlled trial (g2018012). |
| Date of disclosure of the study information | 2019/07/03 |
| Last modified on | 2021/06/18 08:51:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety evaluation of an excessive consumption of a plant-derived functional substance . a randomized, double-blind, placebo-controlled trial (g2018012).
Acronym
Safety evaluation of a plant-derived functional substance.
Scientific Title
Safety evaluation of an excessive consumption of a plant-derived functional substance . a randomized, double-blind, placebo-controlled trial (g2018012).
Scientific Title:Acronym
Safety evaluation of a plant-derived functional substance.
Region
| Japan |
Condition
Condition
Nothing(Healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive consumption of a plant-derived functional substance.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety evaluation (adverse events, clinical laboratory test)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Control food (placebo).
Ingestion of 5 folds dose of recommended daily intake for test food, for 4 weeks.
Interventions/Control_2
Test food (Food containing plant-derived functional substance).
Ingestion of 5 folds dose of recommended daily intake for test food, 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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Japanese adults
Normal body weight
Normal blood pressure
Normal glycometabolism
Normal lipid metabolism
Key exclusion criteria
Pregnancy / Breast-feeding woman
Diabetes mellitus
Dyslipidemia
Cardiovascular disease
Respiratory disease
Abnormal liver function
Abnormal renal function
Endocrine disease
Mental disorder
Immune disorder
Gout
Cancer
Constant use of oral medication
Food allergy
Heavy drinker
Heavy smoker
Inadequate with physician's decision
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takano |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
0040839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
takano@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Takehara |
Organization
Clinical Support Corporation Limited
Division name
Food Service Division
Zip code
0600061
Address
4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido 060-0061 Japan
TEL
011-223-3130
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
Clinical Support Corporation Limited
Institute
Department
Personal name
Funding Source
Organization
Kao Corp
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
Institutional Review Board of Medical Corporation Hokubukai Utsukushigaoka Hospital
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel
011-882-0111
wakimoto@ughp-cpc.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
医療法人北武会 美しが丘病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
protocol was not released
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jhnfa/18/1/18_180101/_article/-char/ja
Number of participants that the trial has enrolled
26
Results
Twenty-six healthy adults were enrolled and randomized into two groups. This study analyzed all participants (n=26). No adverse effects originating in the test or placebo diets were observed in the hematologic tests, blood biochemical tests, urine analysis tests, physical examination, or medical examination/history taking in all participants.
Results date posted
| 2021 | Year | 06 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 06 | Month | 11 | Day |
Baseline Characteristics
Healthy Japanese adults
Participant flow
Twenty-six healthy adults were enrolled and randomized into two groups. This study analyzed all participants (n=26).
Adverse events
No adverse effects originating in the test or placebo diets were observed in the hematologic tests, blood biochemical tests, urine analysis tests, physical examination, or medical examination/history taking in all participants
Outcome measures
Safety was assessed by clinical chemistry, anthropometric measures, and adverse event reporting.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 22 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 26 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 02 | Day |
Last modified on
| 2021 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040970
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
