UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial to investigate whether "health beverage" improves obesity in human
Acronym	A RCT for the effect of "health beverage" on obesity in human
Scientific Title	A randomized controlled trial to investigate whether "health beverage" improves obesity in human
Scientific Title:Acronym	A RCT for the effect of "health beverage" on obesity in human
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of "health beverage" on human obesity.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Computed Tomography Total abdominal adipose tissue area Subcutaneous adipose tissue area Visceral adipose tissue area
Key secondary outcomes	Height Weight BMI Percent body fat Adiponectin Total cholesterol HDL cholesterol LDL cholesterol Triglyceride Free fatty acid

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test material: health beverage 180 ml Tree times/day (540 ml/day)
Interventions/Control_2	Duration: 12 weeks Test material: bottled water 500 ml One bottle per day (500 ml/day)
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	40 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	a) Healthy adults, whose BMI are 25 or larger
Key exclusion criteria	a)Persons who have previous medical history of malignancy, heart failure or myocardial infarction b)Patients being treated for at least one of following diseases; atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and other chronic disease c)Persons who take medicines, herbal medicines, or dietary supplements d)Persons who are allergic to medicines, or foods related to the test material of this trial e)Pregnant women, lactating women, or women who want to get pregnant during the trial period f)Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial g)Persons who are judged not suitable to participate in this trial by physician.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuo YAMAMOTO
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Zip code
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Middle name Last name Naoko SUZUKI
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Zip code
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	AKATSUKA Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seishin-kai Medical Association Inc, Takara Medical Clinic.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	医療法人社団 盛心会 タカラクリニック (東京都) Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 05 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	2014 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date	2014 Year 05 Month 12 Day
Last follow-up date	2014 Year 08 Month 01 Day
Date of closure to data entry	2014 Year 08 Month 01 Day
Date trial data considered complete	2014 Year 09 Month 01 Day
Date analysis concluded	2014 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date	2014 Year 06 Month 04 Day
Last modified on	2017 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016500

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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