UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a Test Food for Body Fat and QOL.
Acronym	Effects of a Test Food for Body Fat and QOL.
Scientific Title	Effects of a Test Food for Body Fat and QOL.
Scientific Title:Acronym	Effects of a Test Food for Body Fat and QOL.
Region	Japan

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

Objectives
Narrative objectives1	Effects of a Test Food for Body Fat and QOL.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Indexes for body fat(1) and QOL(2) (1)Week 0, Week 4, Week 8, Week 12. (2)Week 0, Week 12.
Key secondary outcomes	*Secondary indexes [1]Specific blood test(1). [2]Specific saliva test(1). [3]Specific fecal test(1). [4]Specific urinary test(1). *Safety [1]Blood pressure, pulsation(2). [2]Hematologic test(2). [3]Blood biochemical test(2). [4]Urine analysis(2). [5]Bone density measurement(1). [6]Subject's diary(3). [7]Doctor's questions(2). [8]Side effects and adverse events(4). (1): Week 0, Week 12. (2): Week 0, Week 4, Week 8, Week 12. (3): From the first day of ingestion of a test material to the last day of the test. (4): Week 4, Week 8, Week 12.

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	5
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of the test meal (3 times in a day; 12 weeks).
Interventions/Control_2	Intake of the test meal (3 times in a day; 12 weeks) and exercise (10 min. in a day; 12 weeks).
Interventions/Control_3	Intake of the test meal (3 times in a day; 12 weeks) and oral intake of a supplement A (3 tablets in a day; 12 weeks).
Interventions/Control_4	Intake of the test meal (3 times in a day; 12 weeks) and oral intake of a supplement B (1 tablet in a day; 12 weeks).
Interventions/Control_5	Intake of the test meal (3 times in a day; 12 weeks) and oral intake of a beverage (1 bottle [600 ml] in a day; 12 weeks).
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 and Female
Key inclusion criteria	[1]Healthy Japanese males and females aged 35-65 years. [2]Individuals whose BMI is more than 23.0 kg 2 and less than 30.0 Kg 2 and visceral fat is 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 12 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 1 month. [9]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [10]Individuals who are sensitive to test product or other foods, and medical products. [11]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [12]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [13]Individuals who have a habit to use drug claiming to reduce visceral fat and body fat in the past 3 months. [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 health foods of functional foods. [17]Individuals judged inappropriate for the study by the principal.
Target sample size	500

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	2021 Year 11 Month 09 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 08 Month 24 Day
Date of IRB	2020 Year 08 Month 26 Day
Anticipated trial start date	2021 Year 01 Month 13 Day
Last follow-up date	2021 Year 04 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In order to prevent the spread of coronavirus(COVID-19) infection, the study was started with a delay of 4 weeks from the scheduled start date, and the intake period of the test food was changed from 12 weeks to 8 weeks.

Management information
Registered date	2020 Year 11 Month 09 Day
Last modified on	2022 Year 01 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048175