UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017864
Receipt No. R000020085
Scientific Title Effect of a plant-derived processed product on visceral fat area
Date of disclosure of the study information 2015/07/30
Last modified on 2019/07/25 (Ver. 13)

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Basic information
Public title Effect of a plant-derived processed product on visceral fat area
Acronym Effect of a plant-derived processed product on visceral fat area
Scientific Title Effect of a plant-derived processed product on visceral fat area
Scientific Title:Acronym Effect of a plant-derived processed product on visceral fat area
Region
Japan

Condition
Condition obesity
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of repeated administration of a plant-derived processed product on visceral fat area
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in visceral fat area
Key secondary outcomes abdominal circumference, weight, safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 control diet (product code: C-001), one serving size per day for 12 weeks
Interventions/Control_2 test diet (product code: A-001), one serving size per day 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
35 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1) 25<=BMI<30, 2) abdominal circumference=>85, 3) 35<=Age<65, 4) individual provides informed concent in a documented form
Key exclusion criteria 1) individual with liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases, 2) individual given surgery within 2 months before the trial, 3) medicine user for hyperglycaemia, lipidemia, or hypertension, 4) individual intakes supplements or the food for specific use of health authorized the government, 5) individual experienced unpleasant feeling during blood drawing, 6) individual donated 200 mL or more blood within 1 month before the trial, 7) individual changed his/her weight 2 kg or more within 1 month before the trial, 8) shiftworker, 9) individual plans bussiness trip for 10 consecutive days or more, 10) individual is not familiar with test diet, 11) individual had allergy against any constituents in the test diet, 12) individual can not conform to alcohol limitation, 13) individual can not conform to record of daily life in a format, 14) individual can not conform to record of daily diet for 30 days (3 days X 10 times), 15) individual can not comply with an advice
Target sample size 85

Research contact person
Name of lead principal investigator
1st name Shinichiro
Middle name
Last name Saito
Organization KAO CORPORATION
Division name Health Care Food Research Labs.
Zip code 131-8501
Address 2-1-3 Bunka Sumida-ku Tokyo
TEL 03-5630-7456
Email saito.shinichiro@kao.co.jp

Public contact
Name of contact person
1st name Shinpei
Middle name
Last name Tomita
Organization New Drug Research Center, Inc.
Division name Clinical Research Dept.
Zip code 061-1405
Address 452-1 Toiso, Eniwa-shi, Hokkaido
TEL 0123-34-0412
Homepage URL
Email s-tomita@ndrcenter.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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 The Ethics Review Board of Miyawaki Orthopedic Hospital
Address 3-1-6 Ariake-cho, Eniwa city, Hokkaido
Tel 0123-33-4026
Email d-kameda@mediffom.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 福原医院

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 30 Day

Related information
URL releasing protocol Unpublished due to the protocol including the intellectual property rights
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/jos/advpub/0/advpub_ess16059/_pdf
Number of participants that the trial has enrolled 177
Results 
Significant difference in the primary outcome between the groups
Results date posted
2019 Year 07 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Over weight
Participant flow 
184 were screened, 177 were analyzed
Adverse events 
None associated with the test diets consumption
Outcome measures 
visceral fat area
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 06 Month 10 Day
Date of IRB
2015 Year 06 Month 10 Day
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
2015 Year 12 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 10 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020085