UMIN-CTR Clinical Trial

Basic information
Public title	Effect of test food on triglyceride and LDL-cholesterol level -open trial-
Acronym	Effect of test food on triglyceride and LDL-cholesterol level -open trial-
Scientific Title	Effect of test food on triglyceride and LDL-cholesterol level -open trial-
Scientific Title:Acronym	Effect of test food on triglyceride and LDL-cholesterol level -open trial-
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of the intake of test food on triglyceride and LDL-cholesterol level
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	LDL-cholesterol level
Key secondary outcomes	Triglyceride, total cholesterol, waist circumference

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food (low dose) for 12 consecutive weeks
Interventions/Control_2
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) Males and females from 20 to 64 years of age (2) Serum LDL- cholesterol level are ranged from 120 mg/dL to 139 mg/dL
Key exclusion criteria	(1) Subjects who routinely take foods or medicines affecting the test result (2) Subjects who drink green tea more than once a day (3) Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required (4) Subjects who have under treatment or a history of serious disease (e.g., diabetes, or liver disease, kidney disease, or heart disease) (5) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (6) Subjects having possibilities for emerging allergy related to the study (7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (8) Subjects participating in other clinical study (9) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period (10) Subjects who are judged unfit to enroll in this trial by the investigator
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Masaharu Middle name Last name Ohkawara
Organization	Satoen Co., LTD.
Division name	none
Zip code	421-1392
Address	1057 Ohhara, Aoi-ku, Shizuoka, Japan
TEL	054-270-1336
Email	masaharu-ohkawara@satoen.co.jp

Public contact
1st name of contact person	1st name Hiroyasu Middle name Last name Shimada
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	1-20-2 Ebisu-nishi, Shibuya-ku, Tokyo, Japan
TEL	03-5459-5329
Homepage URL
Email	h.shimada@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	Satoen 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	Aisei Hospital Ueno Clinic Reserch Ethics Committee
Address	2-18-6, Higasiueno, Taito-ku, Tokyo, Japan
Tel	03-6455-0880
Email	t.saito@ttc-smo.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	2019 Year 03 Month 16 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	No longer recruiting
Date of protocol fixation	2019 Year 02 Month 28 Day
Date of IRB	2019 Year 02 Month 28 Day
Anticipated trial start date	2019 Year 03 Month 17 Day
Last follow-up date	2019 Year 08 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	2019 Year 03 Month 15 Day
Last modified on	2019 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041257