UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047024 |
|---|---|
| Receipt number | R000053649 |
| Scientific Title | A long term clinical study for safety evaluation of containing plant-extracts foods. (SME-2021-07) |
| Date of disclosure of the study information | 2022/03/04 |
| Last modified on | 2022/11/29 18:17:23 |
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Basic information
Public title
A long term clinical study for safety evaluation of containing plant-extracts foods. (SME-2021-07)
Acronym
A long term clinical study for safety evaluation of containing plant-extracts foods.
Scientific Title
A long term clinical study for safety evaluation of containing plant-extracts foods. (SME-2021-07)
Scientific Title:Acronym
A long term clinical study for safety evaluation of containing plant-extracts foods.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| 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
Adverse reactions
Key secondary outcomes
Adverse events
Laboratory data, Vital sign
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 12 weeks
Interventions/Control_2
Daily intake of control food for 12 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) Those who are -> 20 years old at the time of IC acquisition and <65 years old at the end of food intake.
(2) Those who have LDL cholesterol of -<119 md/dL or 120-139 md/dL or 140-159 mg/dL/
(3)Those who can come to the investigational site on the designated date
(4) Those who have submitted written informed consent after fully understanding the purpose and content of this study.
Key exclusion criteria
(1) Those with systolic blood pressure less than 90 mmHg at the start of ingestion.
(2) Women who are/might be pregnant or lactating during the study.
(3) Those who have taken >=200 mL whole blood or blood donation within 4 weeks before the start of the intake.
(4) Men who have taken =>400 mL whole blood within 12 weeks before the start of intake.
(5) Women who have taken =>400 mL whole blood within 16 weeks before the start of intake.
(6) Men who have taken =>1,200 mL whole blood total (including the sampling of this study) within 12 months before the start of intake.
(7) Women who have taken =>800 mL whole blood total (including the sampling of this study) within 12 months before the start of intake.
(8) Those who are participating in other study or planning to participate or participated within the past 4 weeks.
(9) Those who meet any of the following:
a) suffering from heart, liver, or kidney disease (including complications of other diseases)
b) having a history of cardiovascular disease
c) diabetes
d) allergic to food
e) having a history of cancer or tuberculosis
f) positive or false-positive by infectious disease test
(10) Those who are receiving any treatment at the time of screening.
(11) Those who regularly use pharmaceuticals (including quasi-drugs), foods for specified health use, foods with functional claims or health foods.
(12) Those who smoke an average of 21 or more cigarettes in a day.
(13) Those who drink an average of more than 60 g of pure alcohol in a day.
(14) Those who have an extremely irregular eating habit.
(15) Shift workers or late-night workers.
(16) Others who are judged inappropriate for participant by the investigator.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | MINAMI |
Organization
Suntory Beverage & Food Limited
Division name
Development & Design Department
Zip code
211-0067
Address
13-2, Imaikami-cho, Nakahara-ku, Kawasaki city, Kanagawa, Japan
TEL
050-3182-6161
Hisako_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | ENDO |
Organization
Suntory Beverage & Food Limited
Division name
Development & Design Department
Zip code
211-0067
Address
13-2, Imaikami-cho, Nakahara-ku, Kawasaki city, Kanagawa, Japan
TEL
050-3182-5680
Homepage URL
Megumi_Endo@suntory.co.jp
Sponsor or person
Institute
Suntory Beverage & Food Limited
Institute
Department
Personal name
Funding Source
Organization
Suntory Beverage & Food Limited
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Clinical Trial Review Committee
Address
1-2-5 Itoyokado Fukuzumiten-5F Fukuzumi-2 jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel
0123-36-8029
s-fukui@jikokai.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
福原医院（北海道） / Fukuhara Clinic (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | 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
| 2022 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 28 | Day |
Last modified on
| 2022 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053649
