UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for evaluating the safety of excessive intake of food containing plant-derived constituent
Title of the study (Brief title)	Study for evaluating the safety of excessive intake of food
Region	Japan

Condition
Condition	None (Healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of excessive intake of food containing plant-derived constituent
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Interview by physician 2. Height and body weight 3. Blood pressure and pulse 4. Hematological test 5. Biochemical test 6. Urine analysis 7. Subjective symptom and objective response 8. Adverse events
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	Food containing plant-derived constituent, 12 portion of food per day for 4 weeks.
Interventions/Control_2	Placebo food, 12 portion of food per day for 4 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)Healthy males and females aged from 20 to less than 65 years old when giving the informed consent. (2)Subjects with BMI from 18.5 to less than 30 kg/m2 at the screening. (3)Subjects giving the informed consents in writing after receiving explanation of the purpose and details of the study, understanding the study and deciding to attend the study with their own will.
Key exclusion criteria	(1)Subjects on a diet. (2)Subjects using medication affecting lipid metabolism. (3)Subjects constantly using supplements or functional foods affecting lipid metabolism (including foods for specified health uses and foods with function claims). (4)Subjects using foods containing ingredients of test food constantly. (5)Subjects with excessive alcohol-drinking behaviors (maximum daily quantity: approximately 20 g of pure alcohol per day). (6)Subjects who cannot stop drinking for two days until the screening and each checkup. (7)Subjects with food allergy. (8)Subjects with serious diseases (e.g., diabetes, kidney disease, liver disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorders. (9)Subjects with chronic diseases and using medicines continuously. (10)Subjects having a medical history of diseases affecting digestion and absorption. (11)Subjects with implantable medical devices (e.g., cardiac pace maker and implantable defibrillator) (12)Subjects judged unsuitable for the study based on the results of blood test. (13)Subjects with anemia. (14)Subjects having donated over 200 mL of blood or blood component within the last one month prior to the current study or over 400 mL of blood or blood component within the last three months prior to the current study. (15)Subjects diagnosed with familial hyperlipidemia. (16)Subjects under treatment or a history of drug addiction and/or alcoholism. (17)Subjects participating or willing to participate in other clinical studies with the intake of food or pharmaceutical products, or with the swab of cosmetic or pharmaceutical products. (18)Subjects who are pregnant, breastfeeding, or planning to be pregnant in the near future. (19)Subjects working for a company developing or manufacturing functional foods. (20)Subjects judged unsuitable for this study by the investigator for other reasons.
Target sample size	40

Research contact person
Name of lead principal investigator	Yoshitaka Iwama
Organization	Nihonbashi Cardiovascular Clinic
Division name	Director
Address	Kyodo Building #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo, Japan
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales Department
Address	Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Co., Ltd
Institute
Department

Funding Source
Organization	Kirin company, Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2018 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 09 Day
Anticipated trial start date	2018 Year 09 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 08 Month 23 Day
Last modified on	2019 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038632