UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043073 |
|---|---|
| Receipt number | R000049176 |
| Scientific Title | A clinical study to evaluate the safety of plant-extracts containing foods. -- Randomized, Placebo controlled, Double-Blind Parallel Study -- (SME-2020-01-HRCT) |
| Date of disclosure of the study information | 2021/02/04 |
| Last modified on | 2021/08/04 11:03:04 |
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Basic information
Public title
A clinical study to evaluate the safety of plant-extracts containing foods. (SME-2020-01-HRCT)
Acronym
A clinical study to evaluate the safety of plant-extracts containing foods.
Scientific Title
A clinical study to evaluate the safety of plant-extracts containing foods. -- Randomized, Placebo controlled, Double-Blind Parallel Study -- (SME-2020-01-HRCT)
Scientific Title:Acronym
A clinical study to evaluate the safety of plant-extracts containing foods.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of plant-extracts foods.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse reactions
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily intake of test food for four weeks
Interventions/Control_2
Daily intake of control food for four 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) Males and females who are -> 20 years old at the time of IC acquisition and <65 years old at the end of food intake
(2) Those who can get blood drawing, urine collection, and physical tests on the designated day
(3) Those who have submitted written informed consent after fully understanding the purpose and content of this study.
Key exclusion criteria
(1) Those who have difficulty in swallowing
(2) Those who are receiving any treatment at the screening
(3) Those with systolic blood pressure less than 90 mmHg at the start of ingestion
(4) Women who are/might be pregnant or lactating during the study
(5) Those who have taken >=200 mL whole blood or blood donation within 4 weeks before the start of the intake
(6) Men who have taken =>400 mL whole blood within 12 weeks before the start of intake
(7) Women who have taken =>400 mL whole blood within 16 weeks before the start of intake
(8) Men who have taken =>1,200 mL whole blood total (including the sampling of this study) within 12 months before the start of intake
(9) Women who have taken =>800 mL whole blood total (including the sampling of this study) within 12 months before the start of intake
(10) Those who are participating in other study or planning to participate or participated within the past 4 weeks.
(11) Those who are:
a) heart, liver, or kidney disease (including complications of other diseases)
b) having a history of cardiovascular disease
c) diabetes
d) allergic to test foods
e) undergoing treatment for or have a history of serious illnesses such as cancer and tuberculosis
f) positive or suspected to be positive in the infectious disease test
(12) Those who regularly use pharmaceuticals (including quasi-drugs), foods for specified health use, foods with functional claims or health foods.
(13) Those who smoke an average of 21 or more cigarettes in a day
(14) Those who drink an average of more than 60 g of pure alcohol in a day
(15) Those who have an extremely irregular eating habit
(16) Shift workers or late night workers
(17) Others who are judged inappropriate for participant by the investigator
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Obata |
Organization
SUNTORY MONOZUKURI EXPERT LIMITED
Division name
HE Center
Zip code
135-8631
Address
2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL
03-5579-1277
Hidenori_Obata@suntory.co.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Sekiguchi |
Organization
SUNTORY MONOZUKURI EXPERT LIMITED
Division name
HE Center
Zip code
135-8631
Address
2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL
03-5579-1277
Homepage URL
N_Sekiguchi@suntory.co.jp
Sponsor or person
Institute
SUNTORY MONOZUKURI EXPERT LIMITED
Institute
Department
Personal name
Funding Source
Organization
Suntory Wellness Limited
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
Fukuhara Clinic Clinical Trial Review Committee
Address
3-1-15 Shimamatsuhigashimachi, Eniwa-shi, Hokkaido
Tel
0123-36-8029
d-kameda@mediffom.co.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
| 2021 | Year | 02 | Month | 04 | 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
| 2021 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 21 | Day |
Last modified on
| 2021 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049176
| Research Plan | |
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| Registered date | File name |
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