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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038722
Receipt No. 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 2019/11/29

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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
Email 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
Email tomaru@khh.biglobe.ne.jp

Sponsor
Institute Ezaki Glico Co., Ltd.
Institute
Department

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
Email 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 Preinitiation
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 29 Day
Last modified on
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043744

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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