UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057143 |
|---|---|
| Receipt number | R000065298 |
| Scientific Title | A Study on the Effect of Food Containing Plant Extract on Capillary Blood Flow -A Randomized, Double-blind, Placebo controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2025/03/03 |
| Last modified on | 2025/02/25 14:43:17 |
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Basic information
Public title
A Study on the Effect of Food Containing Plant Extract on Capillary Blood Flow
-A Randomized, Double-blind, Placebo controlled, Parallel-group 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
-A Randomized, Double-blind, Placebo controlled, Parallel-group 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
Capillary blood flow velocity after 8 weeks of intake
Key secondary outcomes
Capillary image analysis after 8 weeks of intake
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food containing plant extract, 8 weeks consumption
Interventions/Control_2
Food not containing plant extract, 8 weeks consumption
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 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, are shiftworker and/or midnight-shift worker.
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 are under treatment with medications (including OTC and/or prescribed medications).
12)Subjects who have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent, habit of drinking not less than 5 days a week, or can't stop drinking from the days before each measurement.
13)Subjects who smoke 21 or more cigarettes a day, or cannot quit smoking during from waking to inspection completed.
14)Subjects who can't stop their manicure or false nail during the current study periods.
15)Subjects who are participating in other studies or planning to participate at the start of the current study.
16)Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
50
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
5300044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-6135-5200
info@miura-cl.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
5300044
Address
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
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
Tel
06-6135-5200
mterashima@miura-cl.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
| 2025 | Year | 03 | Month | 03 | 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
| 2025 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065298
