UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial to investigate whether decrease in visceral adipose tissue in human
Title of the study (Brief title)	A trial to investigate whether decrease in visceral adipose tissue in human
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of test material intake on decrease in visceral adipose tissue in human
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	subjective symptom Likert scales blood chemical analysis Total cholesterol HDL cholesterol LDL cholesterol Triglyceride Free fatty acid Body analysis Weight BMI Percent body fat waist circumference

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved 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: PROTON GRAN PRO shape and size capsule (standard: size 2) take two capusles twice daily both before breakfast and going to bed during fasting
Interventions/Control_2	Duration: 12 weeks Test material: placebo shape and size capsule (standard: size 2) take two capusles twice daily both before breakfast and going to bed during fasting
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	30 years-old <=
Age-upper limit	49 years-old >=
Gender	Male and Female
Key inclusion criteria	a) Persons whose ages are ranging from 30 to 49 years old b) Persons whose BMIs are 25 or larger c) Persons who stop intaking other supplements during the test if he/she intakes supplement and nutrient enrichment food habitually d) Persons who had alcohol drinking less than twice a week e) Persons who sport less than twice a week
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 d) Persons who are allergic to medicines, or foods related to the test material of this trial e) Persons who take medicines in relation to pollinosis during the trial period f) Pregnant women, lactating women, or women who want to get pregnant during the trial period g) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial h) Persons who are to work or activities in the night i) Persons who are judged not suitable to participate in this trial by physician.
Target sample size	14

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
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	Naoko SUZUKI
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
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	Esthe Pro Labo 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)

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) メディカルスキャニング (東京都) MEDICAL SCANNING (Tokyo)

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 20 Day
Anticipated trial start date	2014 Year 07 Month 10 Day
Last follow-up date	2014 Year 11 Month 30 Day
Date of closure to data entry	2014 Year 12 Month 31 Day
Date trial data considered complete	2014 Year 12 Month 31 Day
Date analysis concluded	2014 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 09 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=R000016892