UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046940 |
|---|---|
| Receipt number | R000053557 |
| Scientific Title | A Study on the Effect of Food Containing Plant Extract on Capillary blood flow-Open Study - |
| Date of disclosure of the study information | 2022/02/18 |
| Last modified on | 2023/06/14 16:46:03 |
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Basic information
Public title
A Study on the Effect of Food Containing Plant Extract on Capillary blood flow-Open Study -
Acronym
A Study on the Effect of Food Containing Plant Extract on Capillary blood flow
Scientific Title
A Study on the Effect of Food Containing Plant Extract on Capillary blood flow-Open Study -
Scientific Title:Acronym
A Study on the Effect of Food Containing Plant Extract on Capillary blood flow
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of food containing plant extract on capillary blood flow
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Status of capillary
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food containing plant extract, 8 weeks consumption
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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Healthy females aged 40 to 59 years-old.
(2) Subjects who aware of coldness.
(3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects who were diagnosed with serious disease (e.g., diabetes, liver disease, kidney disease, digestive disease, heart disease, respiratory disease and/or peripheral vascular disease).
(2) Subjects who had a gastrointestinal surgery.
(3) Subjects with strange finger conditions at measurement points.
(4) Subjects with a disease currently under treatment.
(5) Subjects with drug or food allergies.
(6) Subjects with anemic.
(7) Women who are/might be pregnant or lactating during the current study periods.
(8) Subjects who play high intensity sports and/or are on a diet.
(9) Subjects who have an extremely irregular eating habit.
(10) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods.
(11) Subjects who have alcohol intake more than average 60 g/day of pure alcohol equivalent.
(12) Subjects who smoke an average of 21 or more cigarettes in a day
(13) Subjects who can't stop their manicure or false nail during the current study periods.
(14) Subjects who are participating in other studies or planning to participate at the start of the current study.
(15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal Medicine
Zip code
530-0044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-6135-5200
mterashima@miula.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness support Co., Ltd.
Division name
Clinical trial Division
Zip code
530-0044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Oneness support Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel
06-6135-5200
mterashima@miula.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
| 2022 | Year | 02 | Month | 18 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000053557
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/51010/129
Number of participants that the trial has enrolled
10
Results
Statistically significant difference was confirmed in the primary outcome.
Results date posted
| 2023 | Year | 06 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Females aged 40 to 59 years old.
Participant flow
Enrolled(n=10)
Completed(n=10)
Analysed(n=9)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
Status of capillary
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 05 | 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
| 2022 | Year | 02 | Month | 18 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053557
