UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients. ( SME-2021-01-FOSHUS)
Acronym	A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients.
Scientific Title	A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients.(SME-2021-01-FOSHUS)
Scientific Title:Acronym	A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the blood pressure lowering effect when adult men and women are ingested food containing plant-derived ingredients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Systolic blood pressure / Diastolic blood pressure
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	Prevention
Type of intervention	Food
Interventions/Control_1	Daily intake of test food for 12 weeks
Interventions/Control_2	Daily intake of control food for 12 weeks
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Males and females who are -> 20 years old at the time of IC acquisition and <65 years old at the end of the study. (2) Those who can visit to destination medical institution on the scheduled date. (3) Those who have submitted written informed consent after fully understanding the purpose and content of this study.
Key exclusion criteria	(1) Those who heavy use of alcohol or smoke (2) Those who continuously ingest foods for specified health use, foods with functional claims, health foods, and foods that may affect blood pressure evaluation. (3) Those who continuously take medicines or quasi-drugs (4) Those who are participating in other study or planning to participate or participated within the past 4 weeks. (5) Those who are: a) heart, liver, or kidney disease (including complications of other diseases) b) having a history of cardiovascular disease c) diabetes d) allergic to test foods e) with systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher f) with a BMI of 30 or higher g) having a history or respiratory illness (excluding childhood asthma) (6) Others who are judged inappropriate for participant by the investigator
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Takao Middle name Last name Tanaka
Organization	SUNTORY MONOZUKURI EXPERT LIMITED
Division name	HE Center
Zip code	135-8631
Address	2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL	03-5579-1277
Email	Takao_Tanaka@suntory.co.jp

Public contact
Name of contact person	1st name Noriko Middle name Last name Sekiguchi
Organization	SUNTORY MONOZUKURI EXPERT LIMITED
Division name	HE Center
Zip code	135-8631
Address	2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL	03-5579-1277
Homepage URL
Email	N_Sekiguchi@suntory.co.jp

Sponsor
Institute	SUNTORY MONOZUKURI EXPERT LIMITED
Institute
Department

Funding Source
Organization	Suntory Beverage & Food Limited
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	NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board
Address	West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
Tel	06-4797-5660
Email	jimukyoku@amc-clinc.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 05 Month 27 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	120
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	2021 Year 05 Month 27 Day
Date of IRB	2021 Year 05 Month 27 Day
Anticipated trial start date	2021 Year 05 Month 28 Day
Last follow-up date	2021 Year 11 Month 05 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 05 Month 27 Day
Last modified on	2022 Year 08 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050653