UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023499
Receipt No. R000026735
Scientific Title Effect of a grain-derived processed product on visceral fat area
Date of disclosure of the study information 2016/08/28
Last modified on 2019/07/30 (Ver. 7)

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Basic information
Public title Effect of a grain-derived processed product on visceral fat area
Acronym Effect of a grain-derived processed product on visceral fat area
Scientific Title Effect of a grain-derived processed product on visceral fat area
Scientific Title:Acronym Effect of a grain-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 grain-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 control: product code;P-001
12-wk repeated consumption and 4-wk post treatment observation.
Dose of 1 serving per day.
Visceral fat area measurement every 4-wk.
Interventions/Control_2 Active: product code;S-001
12-wk repeated consumption and 4-wk post treatment observation.
Dose of 1 serving per day.
Visceral fat area measurement every 4-wk.
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1,25<=BMI<30
2,visceral fat area=>100cm2
3,30<=Age<65 of healthy men and women
4,provided written informed consent from subjects
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,skin disease, metal allergy and implanted pacemaker
8,remain constipated 5 days and more
9,changes in weight of 2kg or more within 3 month before the study
10,shift worker
11,business trip and travel planned for 10 consecutive days or more
12,allergies against any constituents in the test diet
13,other clinical study or who intended to participate in one during the study period
14,disagree with explanation for study
15,judged to be inappropriate as subject by physician in charge
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Hirona
Middle name
Last name Miura
Organization Higashi shinjyuku Clinic
Division name Director
Zip code 169-0072
Address 1-11-3 Okubo Shinjuku-ku Tokyo
TEL 03-6233-8581
Email koike@meiseikai-cl.com

Public contact
Name of contact person
1st name Shimpei
Middle name
Last name Tomita
Organization New Drug Research Center, Inc.
Division name Research Division
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 Higashi shinjyuku Clinic
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 Miyawaki orthopedics clinic IRB
Address 3-1-6 Ariakecho, Eniwa-city, Hokkaido
Tel 0123-35-3011
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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 28 Day

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

Result
URL related to results and publications works in progress
Number of participants that the trial has enrolled 120
Results 
There was a significant difference in primary outcome
Results date posted
2019 Year 07 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
overweight
Participant flow 
114 participants completed and 111 subjects were incorporated into the analyses
Adverse events 
No adverse effect related to the test diets reported
Outcome measures 
visceral fat area
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 07 Month 25 Day
Date of IRB
2016 Year 07 Month 25 Day
Anticipated trial start date
2016 Year 08 Month 28 Day
Last follow-up date
2017 Year 01 Month 09 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 08 Month 05 Day
Last modified on
2019 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026735