UMIN-CTR Clinical Trial

Basic information
Public title	A study for safety evaluation of excess consumption of the test food.
Acronym	A study for safety evaluation of excess consumption of the test food.
Scientific Title	A study for safety evaluation of excess consumption of the test food.
Scientific Title:Acronym	A study for safety evaluation of excess consumption of the test food.
Region	Japan

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

Objectives
Narrative objectives1	Safety evaluation when healthy adults consume excess amount of the test food in 4 consecutive weeks.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Presence or absence of, type of, severity of and frequency of side effects and adverse events (include clinical test data).
Key secondary outcomes	The inspection items at 2 and 4 weeks after beginning of ingestion of the test food, and at 2 weeks after end of ingestion of the test food as follows. Medical interview, body length, body weight, body fat percentage, BMI, systolic blood pressure, diastolic blood pressure, heart rate, blood biochemical test (TP, ALB, AST, ALT, LDH, T-BIL, ALP, ganma-GTP, CPK, BUN, CRE, UA, Na, Cl, K, Ca, T-Cho, LDL-Cho, HDL-Cho, TG, GLC, HbA1c) , hematological test (WBC, RBC, Hb, Ht, and PLT), and urine analysis (protein, sugar, urobilinogen, bilirubin)

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 nine capsules,which contain the test food, at once, three times a day, four 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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Male and female aged over 20 years old when consent acquisition. (2)Subjects giving written informed consent.
Key exclusion criteria	(1)Subjects who constantly use oral medicines, food for specific health use, functional display foods and/or supplements having a possibility of affecting test results. (2) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (3) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney, digestive organ. (4) Subjects who excessive alcohol intake. (5) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. (6) Subjects who have previous medical history of drug and/or food allergy. (7) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (8) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (9) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. (10) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (11) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (12) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (13)Subjects who have weak digestive organ. Especially subjects who feel discomfort for example stomach astigmatism after intake of drinks containing tannin like strong green tea, black tea and coffee. (14) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Katsuhisa Middle name Last name Sakano
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	NAGAOKA 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.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	2018 Year 07 Month 26 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	2017 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 26 Day
Last modified on	2020 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032487