UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043744