UMIN-CTR Clinical Trial

Basic information
Public title	Study for the Effects of a Test Food on Visceral Fat.
Acronym	Study for the Effects of a Test Food on Visceral Fat.
Scientific Title	Study for the Effects of a Test Food on Visceral Fat.
Scientific Title:Acronym	Study for the Effects of a Test Food on Visceral Fat.
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 examine efficacy of a test food on visceral fat.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Indexes for visceral fat and body fat.(1) (1):Screening, Week 0, Week 1, Week 2.
Key secondary outcomes	*Secondary indexes [1]Specific blood test(1). [2]Specific saliva test(2). [3]Specific fecal test(2). [4]QOL(2). [5]Specific exhalation test(2). *Safety [1]Blood pressure, pulsation(1). [2]Hematologic test(1). [3]Blood biochemical test(1). [4]Urine analysis(1). [5]Bone density measurement(2). [6]Subject's diary(3). [7]Doctor's questions(1). [8]Side effects and adverse events(2). (1):Screening, Week 0, Week 1, Week 2. (2):Week 0, Week 1, Week 2. (3): Everyday From the seven days before the first day of ingestion of a test material to the last day of the test. *Other indexes Dietary survey (4) (4):Week 0 (for 3 days), Week 2 (for 3 days).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of the test meal (3 times in a day; 2 weeks).
Interventions/Control_2	Intake of the test meal (3 times in a day; 2 weeks) and exercise (10 min. in a day; 2 weeks).
Interventions/Control_3	Intake of normal meals (keeping habit of eating before participating with the study; 2 weeks).
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	30 years-old <=
Age-upper limit	65 years-old >
Gender	Male
Key inclusion criteria	[1] Healthy Japanese males aged 30-64 years. [2] Individuals whose BMI is not less than 23 kg/m2 and under 30 kg/m2 and visceral fat level is relatively high. [3]Individuals whose written informed consent has been obtained. [4]Individuals who can visit an inspection facility and be inspected in designated days. [5]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals who cannot continue to eat a test meal for 2 weeks. [2]Individuals who are in constipation. [3]Individuals using medical products. [4]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [5]Individuals who used or applied a drug for treatment of disease in the past 1 month. [6]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [7]Individuals who contract or have a history of serious endocrine disease. [8]Individuals who recorded weight gain and loss (+-2 kg) in the past 3 months. [9]Individuals who have a plan to take health checkup from 2 weeks before Week 0 to the last day of the test. [10]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [11]Individuals who are sensitive to test product or other foods, and medical products. [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). [13]Individuals who smoke over 21 cigarettes in a day. [14]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [15]Individuals who have a habit to use drug claiming to reduce visceral fat and body fat in the past 3 months. [16]Individuals who participated in other clinical studies in the past 3 months. [17]Individuals who are or whose family is engaged in health foods of functional foods. [18]Individuals judged inappropriate for the study by the principal.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6240-1162
Email	info@ueno-asagao.clinc

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	Non-disclosure
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	2022 Year 05 Month 21 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	No longer recruiting
Date of protocol fixation	2021 Year 04 Month 06 Day
Date of IRB	2021 Year 04 Month 07 Day
Anticipated trial start date	2021 Year 06 Month 05 Day
Last follow-up date	2021 Year 07 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 12 Day
Last modified on	2021 Year 08 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050300

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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