UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination study on abdominal visceral fat reducing action by functional food intake -Randomized placebo-controlled double-blind parallel group comparison study-
Title of the study (Brief title)	Examination study on abdominal visceral fat reducing action by functional food intake
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of intake of functional food for 12 weeks on abdominal fat area reduction and safety in males and females with abdominal obesity aged 20-64
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	<Efficacy> Abdominal visceral fat area, at 8 and 12 weeks after intake <Safety> Side effect incidence
Key secondary outcomes	<Efficacy> Abdominal subcutaneous fat area and abdominal whole fat area, at 8 and 12 weeks after intake Waist circumference diameter, hip circumference diameter, body weight, BMI, total cholesterol, HDL-cholesterol, LDL-cholesterol, and fasting blood glucose at 4,8 and 12 weeks after intake HbA1c and adiponectin at 12 weeks after intake <Safety> Adverse event incidence, clinical examination items excluding efficacy evaluation items, and physiological examination items excluding efficacy evaluation items

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food for 12 weeks
Interventions/Control_2	Intake of placebo food for 12 weeks
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. Males and females equal to or more than 20 years and less than 65 years of age 2. Subjects equal to or more than 24 and less than 30 kg/m^2 of BMI 3. Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria	1. Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs 2. Subjects who fall under the diagnostic criteria of metabolic syndrome 3. Subjects who received medication treatment or surgery due to serious illness or injury within 2 months from the start of this study 4. Subjects who use drugs of glycometabolism, lipidmetabolism, or reducing high blood pressure 5. Subjects who regularly use drugs, health foods, supplements which are suggested causal relationship from the study except who agree to quit taking them 6. Pregnant and lactating female, or who wish to get pregnant during the study period 7. Heavy dinkers 8. Subjects who feel bad mood by blood collection in past 9. Subjects who donated 200 mL or more of blood within 1 month from the start of the test or subjects who plan to do so during the test period 10. Subjects who have been constipated for more than 5 days 11. Shift worker 12. Subjects who have allergy related to the test foods 13. Subjects already participating in other clinical trials, subjects planning to participate during this examination period 14. Subjects who can not agree with the purpose of this test conducted in advance 15. Subjects who are ineligible due to physician's judgment
Target sample size	70

Research contact person
Name of lead principal investigator	Ikuo Fukuhara
Organization	Fukuhara Clinic
Division name	Hospital director
Address	3-1-15 Shimamatsuhigashi-machi Eniwa, Hokkaido, Japan
TEL	0123-36-8029
Email	i-feniwa@gray.plala.or.jp

Public contact
Name of contact person	Tomita Shimpei
Organization	New drug research center, Inc.
Division name	Clinical Research Dept.
Address	452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL	0123-34-0412
Homepage URL
Email	s-tomita@ndrcenter.co.jp

Sponsor
Institute	Maruzen Pharmaceuticals Co., Ltd.
Institute
Department

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

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 23 Day
Anticipated trial start date	2017 Year 04 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 02 Month 24 Day
Last modified on	2017 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030198