UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of long term intake of test supplement on safety -open labeled study-
Acronym	Safety of long term intake of test supplement
Scientific Title	Evaluation of long term intake of test supplement on safety -open labeled study-
Scientific Title:Acronym	Safety of long term intake of test supplement
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to assess the safety of 12 consecutive weeks of intake of test supplement
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Weight/body mass index Doctor's question Adverse event
Key secondary outcomes

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 of test supplement for 12 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Male and female whose age is between 20 and 64 years old
Key exclusion criteria	(1) Subjects who have diabetes, liver disease, kidney disease, heart disease, diseases that affect the secretion of adrenocortical hormones, other metabolic diseases, or subjects who have a history of such diseases (2) Subjects who have diseases requiring continuous medication, or serious medical history who needed medication (3) Subjects who routinely use some medicine (including over-the-counter drug) (4) Subjects who are judged as unsuitable for the study based on the results of clinical laboratory test or cardiopulmonary function (5) Subjects with allergies to the test food in this study (6) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period (7) Subjects who have participated in other clinical study within the past month prior (8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (9) Subjects who are judged as unsuitable for the study based on the results of clinical laboratory test or physical examination (10) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code	2440806
Address	12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	0458203755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Yoshimi Middle name Last name Bansho
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	1-20-2, Ebisu-nishi, Shibuya-ku, Tokyo, Japan
TEL	03-5459-5329
Homepage URL
Email	y.bansho@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Aisei Hospital Ueno Clinic Research Ethics Committee
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.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	メディカルステーションクリニック 公益財団法人愛世会 愛誠病院 上野クリニック

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 15 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	2019 Year 06 Month 27 Day
Date of IRB	2019 Year 06 Month 28 Day
Anticipated trial start date	2019 Year 07 Month 30 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 03 Day
Last modified on	2020 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042473