UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025279 |
|---|---|
| Receipt number | 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 13:40:47 |
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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
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
j-fujii@ndrcenter.co.jp
Sponsor or person
Institute
Higashi sinjyuku clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028241
