UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021970
Receipt No. R000025166
Scientific Title Effect of a plant-derived processed product on visceral fat area
Date of disclosure of the study information 2016/05/10
Last modified on 2019/07/25 (Ver. 7)

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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 healthy humans
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of plant-derived processed product on visceral fat area
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visceral fat area
Key secondary outcomes

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 12-wk repeated consumption of control product (product code A-001), visceral fat area measurement every 4wk, pre-treatment observation period (4wk), post-treatment observation period (4wk) , dose of 1 serving per day
Interventions/Control_2 12-wk repeated consumption of test product (product code B-001), visceral fat area measurement every 4wk, pre-treatment observation period (4wk), post-treatment observation period (4wk), dose of 1 serving per 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
35 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1,25<=BMI<30, 2,visceral fat area=>120cm2, 3,35<=Age<65 of men and postmenopausal women, 4,provides informed consent in a documented form
Key exclusion criteria 1,liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases, 2,surgery or therapy within 2 months before the trial, 3,medicine user for hyperglycaemia, lipidemia, or hypertension, 4,user of supplements or foods with health claim, 5,unpleasant feeling during blood drawing, 6,donated 200 mL or more blood within 1 month before the trial, 7,changed weight 2 kg or more within 1 month before the trial, 8,shiftworker, 9,plans business trip for 10 consecutive days or more, 10, allergy against any constituents in the test diet, 11, participant in the other trial or plan to be, 12, cannot provide informed consent, 13, judged to be inappropriate as subject by physician in charge
Target sample size 126

Research contact person
Name of lead principal investigator
1st name Atsuko
Middle name
Last name Mori
Organization Oriental Ueno Kenshin Center
Division name Head of center
Zip code 110-0005
Address 1-20-11 Ueno Taito-ku Tokyo 110-0005
TEL 03-5816-0711
Email ueno-center@oriental-gr.com

Public contact
Name of contact person
1st name Toshiyasu
Middle name
Last name Tamura
Organization TES Holdings Co. Ltd
Division name Sales Department of Regenerative Medicine and Clinical Trials
Zip code 103-0027
Address 6F Univ. of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL 03-6801-8480
Homepage URL
Email t.tamura@tes-h.co.jp

Sponsor
Institute Oriental Ueno Kenshin Center
Institute
Department

Funding Source
Organization Health Care Food Research Laboratories, 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 Ethical Committee of the Oriental Ueno Kenshin Center
Address 421-1, Zitoukata, Ugeo City
Tel 03-5816-0711
Email ueno-center@oriental-gr.com

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
2016 Year 05 Month 10 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 http://onlinelibrary.wiley.com/doi/10.1002/oby.21938/epdf
Number of participants that the trial has enrolled 114
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 
overweight and obesity
Participant flow 
126 were screened and 114 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
2016 Year 04 Month 18 Day
Date of IRB
2016 Year 04 Month 18 Day
Anticipated trial start date
2016 Year 05 Month 30 Day
Last follow-up date
2017 Year 12 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 18 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=R000025166