UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038722 |
|---|---|
| Receipt number | R000043744 |
| Scientific Title | A clinical study for the effects of a plant extract on improving vascular endothelial function - Randomized, double-blind, placebo-controlled parallel-group comparative study |
| Date of disclosure of the study information | 2019/11/30 |
| Last modified on | 2020/11/29 14:30:35 |
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Basic information
Public title
A clinical study for the effects of a plant extract on improving vascular endothelial function - Randomized, double-blind, placebo-controlled parallel-group comparative study
Acronym
A clinical study for the effects of a plant extract on improving vascular endothelial function
Scientific Title
A clinical study for the effects of a plant extract on improving vascular endothelial function - Randomized, double-blind, placebo-controlled parallel-group comparative study
Scientific Title:Acronym
A clinical study for the effects of a plant extract on improving vascular endothelial function
Region
| Japan |
Condition
Condition
Healthy Individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of intake of a plant extract for 12 weeks on improving vascular endothelial function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Flow-mediated dilation
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Inatake of the food containing paprika-xanthophyll 9mg (once a day, 12weeks)
Interventions/Control_2
Intake of the placebo foods (once a day, 12weeks)
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Subjects whose LDL-cho is is relatively high.
(2)Subjects whose FMD is 0% or more and less than 6.0%.
(3)Subjects whose BMI is 25.0 or more and less than 30.0.
(4)Subjects who can visit the clinic facility on the scheduled visit date.
(5)Subjects who have a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria
(1) Subjects who have received some kind of treatment or care at the time of study participation.
(2)Subjects who are during pregnancy or lactation, and intend to be pregnant during the study period.
(3)Subjects who have a smoking habit
(4)Subjects having blood sample of 200 mL within 4 week at the start of this study.
(5)Subjects having blood sample of 400 mL within 16 week at the start of this study.
(6)Subjects having blood sample of 1000 mL or more than within 48 hours at the start of intake of test food.
(7)Subject in other clinical trials or trials.
(8)Subjects who fall under any of the following items.
a. Subjects who have heart, liver, or kidney disease (including complications of other diseases)
b.Subjects with a history of cardiovascular disease.
c.Subjects who have diabetes.
d. Subjects with or having a history of serious diseases such as cancer and asthma.
(9)Subjects who have a history of major surgery in the gastrointestinal tract such as gastrectomy, gastrointestinal suture, and intestinal resection.
(10)Subjects who have severe food allergies.
(11)Subjects who regularly use supplements, vegetable juice, and tomato juice that have the same ingredients as the test food.
(12)Subjects who cannot refrain from taking Citrus unshiu during the test period (including the pre-observation period).
(13)Subjects determined to be inappropriate by the investigator.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kuriki |
Organization
Ezaki Glico Co., Ltd.
Division name
Institute of Health Sciences.
Zip code
555-8502
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka, Japan
TEL
06-6477-8425
takashi.kuriki@glico.com
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Tomaru |
Organization
Synapse Planning co.Ltd.
Division name
Clinical Trial Session
Zip code
116-0014
Address
Cresco First Building 3F, 5-45-1 higashi-Nippori, Arakawa-Ku, Tokyo, Japan
TEL
03-5604-9442
Homepage URL
tomaru@khh.biglobe.ne.jp
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate school of Agricultural Sciences, Tohoku University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Tsukiji Futaba Clinic
Address
Tsukiji 1-9-9, Chuou-ku, Tokyo, Japan
Tel
03-6226-5812
tohru@hikobae.net
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
東京シーサイドクリニック(東京）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 30 | 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
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 29 | Day |
Last modified on
| 2020 | 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=R000043744
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| Research case data specifications | |
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| Registered date | File name |
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