UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Effect of Food Containing Plant Extract on Platelet Aggregation -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym	A Study on the Effect of Food Containing Plant Extract on Platelet Aggregation
Scientific Title	A Study on the Effect of Food Containing Plant Extract on Platelet Aggregation -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym	A Study on the Effect of Food Containing Plant Extract on Platelet Aggregation
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 platelet aggregation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	platelet aggregation
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Foods containing plant extract, 12 weeks consumption
Interventions/Control_2	Foods not containing plant extract, 12 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy men and women aged 40 to 64 years old. (2) Subjects with a BMI < 30. (3) Subjects who can make self-judgment and voluntarily give written informed consent.
Key exclusion criteria	(1)Subjects who have a chronic disease and regularly use medications. (2) Subjects who cannot stop using supplements, and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during the test periods. (3) Subjects with a history and/or presence of serious diseases (e. g., liver disease, kidney disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease). (4) Subjects who had a history of digestive diseases and/or underwent a surgical procedure for digestive disease. (5) Subjects who declared allergic reactions to foods. (6) Subjects who had excessive alcohol intake of > 60 g/day of pure alcohol equivalent or habit of drinking not less than five days a week. (7)Subjects with a history of and/or current drug addiction and/or alcoholism. (8) Subjects unable to cease drinking for two days before each measurement. (9) Subjects who are shift workers and/or night-shift workers. (10) Subjects who were pregnant or planned to become pregnant or breastfeed during the study period. (11) Subjects who had donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the three months prior to the current study. (12) Subjects who were planning to participate and/or had participated in other clinical studies within the month prior to the commencement of the current study. (13) Subjects who were judged as unsuitable for the current study by screening tests. (14) Subjects who were judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Sagami
Organization	Shinagawa Season Terrace Health Care Clinic
Division name	Doctor
Zip code	108-0075
Address	The 5th floor of Shinagawa season terrace, 1-2-70, Konan, Minato-ku, Tokyo
TEL	03-3452-3382
Email	shibaura@sempos.or.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

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	Ethical Committee of Nihonbashi Cardiology Clinic
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.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	2021 Year 01 Month 08 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	2020 Year 12 Month 10 Day
Date of IRB	2020 Year 12 Month 14 Day
Anticipated trial start date	2021 Year 01 Month 09 Day
Last follow-up date	2021 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	2021 Year 01 Month 07 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049004

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.