UMIN-CTR Clinical Trial

Basic information
Public title	Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Acronym	Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Scientific Title	Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Scientific Title:Acronym	Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate safety of overconsumption of a functional food on healthy adult males and females.
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 0, Week 2, Week 4).
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]Blood pressure, pulsation (Week 0, Week 2, Week 4). [3]Weight, body fat percentage, BMI (Week 0, Week 2, Week 4). [4]Hematologic test (Week 0, Week 2, Week 4). [5]Blood biochemical test (Week 0, Week 2, Week 4). [6]Urine analysis (Week 0, Week 2, Week 4). [7]Doctor's questions (Week 0, Week 2, Week 4). *Other index [1]Subject's diary (each day during the test period).

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	Treatment
Type of intervention	Food
Interventions/Control_1	Oral intake of the test product (10 capsules in a day; 4 weeks).
Interventions/Control_2	Oral intake of the placebo product (10 capsules in a day; 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]Males and females aged 20-64 years. [2]Individuals who are healthy and have no chronic physical disease including skin disorder. [3]Individuals whose written informed consent has been obtained. [4]Individuals who can come to the designated venue for this study and be inspected. [5]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 BMI is less than 18.5kg/m2 and over 30kg/m2. [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 the test food. [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 excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [13]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [14]Individuals who are or are possibly, or are lactating. [15]Individuals who participated in other clinical studies in the past 3 months. [16]Individuals who are or whose family is engaged in functional foods or cosmetics. [17]Individuals judged inappropriate for the study by the principal.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Kondo
Organization	Medical Corporation Meiseikai, Higashi Shinjuku Clinic
Division name	Head
Zip code	169-0072
Address	3F Daito Bldg. 1-11-3 Okubo Shinjuku-ku Tokyo 169-0072, JAPAN
TEL	+81-3-6233-8583
Email	h.kondo@meiseikai-cl.com

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, 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	Nikken Foods 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	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81-3-6240-1162
Email	i.takahashi@tes-h.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	2020 Year 11 Month 11 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 10 Month 23 Day
Date of IRB	2020 Year 10 Month 26 Day
Anticipated trial start date	2020 Year 11 Month 12 Day
Last follow-up date	2020 Year 12 Month 14 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 11 Month 10 Day
Last modified on	2021 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048401