UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000025279
Receipt No. R000028241
Scientific Title The short-Term effect of a grain-derived processed food product ingestion on visceral fat area : a randomized controlled trial.
Date of disclosure of the study information 2017/01/10
Last modified on 2019/07/30 (Ver. 7)

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Basic information
Public title The short-Term effect of a grain-derived processed food product ingestion on visceral fat area : a randomized controlled trial.
Acronym The short-Term effect of a grain-derived processed food product ingestion on visceral fat area : a randomized controlled trial.
Scientific Title The short-Term effect of a grain-derived processed food product ingestion on visceral fat area : a randomized controlled trial.
Scientific Title:Acronym The short-Term effect of a grain-derived processed food product ingestion on visceral fat area : a randomized controlled trial.
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
4-wk repeated consumption
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 control
*body weight measurement every day at home
*visceral fat area measurement every 2-wk.
Interventions/Control_2 active: product code; S-001
*4-wk repeated consumption
*body weight measurement every day at home
*visceral fat area measurement every 2-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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1, 23<=BMI<30
2, 20<=Age<65 of healthy men and women
3, provided written informed consent from subjects
Key exclusion criteria 1, can't attend all of test SCR, 0,2 and 4-wk
2, liver, kidney and heart disease, or disorder of respiration endocrine, metabolism, nervous system consciousness, or diabetes, or other diseases
3, parson deviation from reference value of clinical trial, and are diagnosed with doctor
4, surgery or therapy within 2 months before the trial
5, medicine user for hyperglycaemia, lipidemia, or hypertension
6, user of supplements or foods with health claim
7, unpleasant feeling during blood drawing
8, donated 200mL or more blood within l month before the trial
9, skin disease, metal allergy and implanted pacemaker
10, changes in weight of 3kg or more within 3 month before the study
11, shift worker
12, business trip and travel planned for 5 consecutive days or more
13, allergies against any constituents in the test diet
14, heavy user of alcohol (800mL<=ingestion beer)
15, other clinical study or who intended to participate in one during the study period
16, can't write the dietary record, life record and body weight record
17, disagree with explanation for study
18, judged to be inappropriate as subject by physician in charge
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Haruna
Middle name
Last name Miura
Organization Higashi sinjyuku clinic
Division name Director
Zip code 169-0072
Address 1-11-3 Okubo Shinjuku-ku Tokyo
TEL 03-6233-8581
Email d-kameda@mediffom.co.jp

Public contact
Name of contact person
1st name Junko
Middle name
Last name Fujii
Organization New drag Research Center, Inc
Division name Clinical Research Development
Zip code 105-0001
Address 2-7-5 Toranomon Minato-ku Tokyo
TEL 03-5510-6908
Homepage URL
Email j-fujii@ndrcenter.co.jp

Sponsor
Institute Higashi sinjyuku 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 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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 10 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 44
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 
healthy human
Participant flow 
43 participants completed and 40 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 11 Month 28 Day
Date of IRB
2016 Year 11 Month 29 Day
Anticipated trial start date
2016 Year 12 Month 16 Day
Last follow-up date
2017 Year 02 Month 07 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 12 Month 15 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=R000028241