UMIN-CTR Clinical Trial

Basic information
Public title	A long term clinical study for safety evaluation of containing plant-extracts foods. (SME-2021-07)
Acronym	A long term clinical study for safety evaluation of containing plant-extracts foods.
Scientific Title	A long term clinical study for safety evaluation of containing plant-extracts foods. (SME-2021-07)
Scientific Title:Acronym	A long term clinical study for safety evaluation of containing plant-extracts foods.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of plant-extracts foods.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse reactions
Key secondary outcomes	Adverse events Laboratory data, Vital sign

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) Those who are -> 20 years old at the time of IC acquisition and <65 years old at the end of food intake. (2) Those who have LDL cholesterol of -<119 md/dL or 120-139 md/dL or 140-159 mg/dL/ (3)Those who can come to the investigational site on the designated date (4) Those who have submitted written informed consent after fully understanding the purpose and content of this study.
Key exclusion criteria	(1) Those with systolic blood pressure less than 90 mmHg at the start of ingestion. (2) Women who are/might be pregnant or lactating during the study. (3) Those who have taken >=200 mL whole blood or blood donation within 4 weeks before the start of the intake. (4) Men who have taken =>400 mL whole blood within 12 weeks before the start of intake. (5) Women who have taken =>400 mL whole blood within 16 weeks before the start of intake. (6) Men who have taken =>1,200 mL whole blood total (including the sampling of this study) within 12 months before the start of intake. (7) Women who have taken =>800 mL whole blood total (including the sampling of this study) within 12 months before the start of intake. (8) Those who are participating in other study or planning to participate or participated within the past 4 weeks. (9) Those who meet any of the following: a) suffering from heart, liver, or kidney disease (including complications of other diseases) b) having a history of cardiovascular disease c) diabetes d) allergic to food e) having a history of cancer or tuberculosis f) positive or false-positive by infectious disease test (10) Those who are receiving any treatment at the time of screening. (11) Those who regularly use pharmaceuticals (including quasi-drugs), foods for specified health use, foods with functional claims or health foods. (12) Those who smoke an average of 21 or more cigarettes in a day. (13) Those who drink an average of more than 60 g of pure alcohol in a day. (14) Those who have an extremely irregular eating habit. (15) Shift workers or late-night workers. (16) Others who are judged inappropriate for participant by the investigator.
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Hisako Middle name Last name MINAMI
Organization	Suntory Beverage & Food Limited
Division name	Development & Design Department
Zip code	211-0067
Address	13-2, Imaikami-cho, Nakahara-ku, Kawasaki city, Kanagawa, Japan
TEL	050-3182-6161
Email	Hisako_Nakamura@suntory.co.jp

Public contact
Name of contact person	1st name Megumi Middle name Last name ENDO
Organization	Suntory Beverage & Food Limited
Division name	Development & Design Department
Zip code	211-0067
Address	13-2, Imaikami-cho, Nakahara-ku, Kawasaki city, Kanagawa, Japan
TEL	050-3182-5680
Homepage URL
Email	Megumi_Endo@suntory.co.jp

Sponsor
Institute	Suntory Beverage & Food Limited
Institute
Department

Funding Source
Organization	Suntory Beverage & Food Limited
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Clinical Trial Review Committee
Address	1-2-5 Itoyokado Fukuzumiten-5F Fukuzumi-2 jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel	0123-36-8029
Email	s-fukui@jikokai.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	福原医院（北海道） / Fukuhara Clinic (Hokkaido)

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 04 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	2022 Year 02 Month 25 Day
Date of IRB	2022 Year 02 Month 25 Day
Anticipated trial start date	2022 Year 03 Month 05 Day
Last follow-up date	2022 Year 07 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 02 Month 28 Day
Last modified on	2022 Year 11 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053649