UMIN-CTR Clinical Trial

Basic information
Public title	Safety-verification trial about excessive intake of test beverage
Acronym	Safety-verification trial about excessive intake of test beverage
Scientific Title	Safety-verification trial about excessive intake of test beverage
Scientific Title:Acronym	Safety-verification trial about excessive intake of test beverage
Region	Japan

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

Objectives
Narrative objectives1	In order to confirm whether an excessive intake of the test beverage could have sufficient safety.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence rates of some kind of adverse event and/or side effect
Key secondary outcomes	1. Physical measurement 2. Physiological test 3. Hematological test 4. Blood-biochemical test 5. General urinalysis

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	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of the test beverage (3 bottles/day) to the subjects for 4 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	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy male/female subjects ranging in age from 20 to 59 (including four subjects with some constipation tendency). (2) Subjects who give informed consent to participate in this clinical trial after being provided with an explanation of our experimental protocol detail.
Key exclusion criteria	(1) Subjects with some kind of continuous medical treatment. (2) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs. (3) Subjects who have constantly used the following foods that might affect their blood glucose level, triglyceride level, and intestine-regulating function; health-specific, functional, health foods. (4) Subjects with excessive alcohol intake. (5) Subjects with extremely irregular dietary habits and/or life rhythm. (6) Pregnant or possibly pregnant women, or lactating ones. (7) Subjects with drug and/or food allergy (especially in milk and soybean). (8) Subjects with weak stomach and/or diarrhea-prone constitution. (9) Subjects who are now under the other clinical tests with some kind of medicine/food, or participated those tests within four weeks after this clinical trial. (10) Subjects who donated over 200 mL of their blood and/or blood components within a month to this clinical trial. (11) Males who donated their whole blood (400 mL) within the last three months to this trial. (12) Females who donated their whole blood (400 mL) within the last four months to this trial. (13) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (14) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (15) Others who have been determined as ineligible for participation in this trial, according to the principal/sub investigator's opinions.
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Division of Clinical Research
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, 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 Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, 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	JAPAN SANGARIA BEVERAGE 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	2021 Year 08 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	2020 Year 07 Month 20 Day
Date of IRB	2020 Year 07 Month 17 Day
Anticipated trial start date	2020 Year 08 Month 04 Day
Last follow-up date	2020 Year 09 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 30 Day
Last modified on	2021 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047074