UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053408 |
|---|---|
| Receipt number | R000060950 |
| Scientific Title | Effects of plant-extracts containing foods on circulatory system |
| Date of disclosure of the study information | 2024/01/24 |
| Last modified on | 2024/01/22 10:54:47 |
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Basic information
Public title
Effects of plant-extracts containing foods on circulatory system
Acronym
Effects of plant-extracts containing foods on circulatory system
Scientific Title
Effects of plant-extracts containing foods on circulatory system
Scientific Title:Acronym
Effects of plant-extracts containing foods on circulatory system
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 effect of plant-extracts foods on circulatory system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diameter of thoracic duct
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Test food 1 (2 weeks) -Washout period(4weeks)-Test food 2 (2 weeks)
Interventions/Control_2
Test food 2 (2 weeks) -Washout period(4weeks)-Test food 1 (2 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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy male and female who are 20 <= years old <50 at the time of consent.
2)Subjects who can visit the designated facility on measurement days.
3)Subjects who can make self-judgment and voluntarily gave informed consent.
Key exclusion criteria
1)Subjects in pregnancy
2)Subjects in lactation
3)Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks, or who will join those after the consent.
4)Subjects who have a disease for which they are undergoing treatment and are taking pharmaceuticals (excluding applied drugs, OTC drugs, and quasi-drugs), or who are likely to take pharmaceuticals (excluding applied drugs, OTC drugs, and quasi-drugs) during the study period.
5) Subjects with dysphagia
6) Subjects who are applicable to following items
a) Subjects with disease on heart, liver, kidney or other organs complication.
b) Subjects with a previous history of disease on circulatory organs.
c)Subjects with a history of coronary artery disease
d)Subjects who are contracting diabetes.
e) Subjects who are allergic to the test food and required one.
f) Subjects with a history of lymph node dissection or treatment with anticancer drugs (taxanes)
7)Subjects who have periodically used OTC drugs, quasi-drugs and health-specific / functional / health foods including supplements, which might affect this study.
8)Heavy alcohol drinkers or excessive smokers.
9) Subject who are scheduled to work day and night shifts and night shifts during this examination period.
10) Subjects who have difficulty maintaining daily routines
11) Others who were judged as inappropriate for participation by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Minami |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1734-6161
Hisako_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Takata |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1734-6653
Homepage URL
Kyoko_Takata@suntory.co.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
None
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
IRB of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6-1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.com
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
| 2024 | Year | 01 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 22 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060950
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
