UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety of Overconsumption of a Test Food
Title of the study (Brief title)	Safety of Overconsumption of a Test Food
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines safety of overconsumption (4 weeks) of a test food.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed) (Week 2, Week 4, 2 weeks after the end of ingestion of a test food) .
Key secondary outcomes	*Secondary outcomes [1]Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . [2]Blood pressure, pulsation (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . [3]Weight, body fat percentage, BMI (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . [4]Hematologic test (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . [5]Blood biochemical test (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . [6]Urine analysis (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . [7]Doctor's questions (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) . *Other index [1]Subject's diary (each day during the test period).

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	Oral intake of the test product (354mL in a day 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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	[1]Males and females aged 20-65 years. [2]Individuals who are healthy and have no chronic physical disease. [3]Individuals whose fasting blood glucose is over 100mg/dL, and less than 110mg/dL or over 110mg/dL, less than 126mg/dL. [4]Individuals whose BMI is over 18.5 and under 30. [5]Individuals whose written informed consent has been obtained. [6]Individuals who can come to the designated venue for this study and be inspected. [7]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals using medical products. [2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [5]Individuals who are a patient or have a history of or endocrine disease. [6]Individuals whose fasting blood glucose is over 126mg/dL or HbA1c (NGSP) is over 6.5%. [7]Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively. [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [9]Individuals who experienced unpleasant feeling during blood drawing. [10]Individuals who are sensitive to a test product or other foods, and medical products. [11]Individuals who habitually take the foods for specified health uses (FOSHU) or functional food (except for subjects who can stop consume them after informed consent). [12]Individuals who have a habit to intake a product similar with a test food. [13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [14]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [15]Individuals who are or are possibly, or are lactating. [16]Individuals who participated in other clinical studies in the past 3 months. [17]Individuals who cannot refrain from eating between meals. [18]Individuals who are or whose family is engaged in functional foods or cosmetics. [19]Individuals judged inappropriate for the study by the principal.
Target sample size	24

Research contact person
Name of lead principal investigator	Mamoru Oki
Organization	Seishukai Medical Corporation Seishukai Hospital
Division name	Head
Address	3-18-5 Matsugaya Taito-ku Tokyo 111-0036, JAPAN
TEL	03-3847-8866
Email	info@tes-h.co.jp

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd
Division name	Administrative Department of Clinical Trials
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization	Hakkaisan Brewery Co., Ltd.
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 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 15 Day
Anticipated trial start date	2018 Year 02 Month 11 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 02 Month 08 Day
Last modified on	2018 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035617