UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025750 |
|---|---|
| Receipt number | R000028884 |
| Scientific Title | Non-inferiority test of a cereal-derived processed product on visceral fat area :a randomized, double-blind, non-inferiority crossover study |
| Date of disclosure of the study information | 2017/01/19 |
| Last modified on | 2019/08/26 14:48:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Non-inferiority test of a cereal-derived processed product on visceral fat area :a randomized, double-blind, non-inferiority crossover study
Acronym
Non-inferiority test of a cereal-derived processed product on visceral fat area
Scientific Title
Non-inferiority test of a cereal-derived processed product on visceral fat area :a randomized, double-blind, non-inferiority crossover study
Scientific Title:Acronym
Non-inferiority test of a cereal-derived processed product on visceral fat area
Region
| Japan |
Condition
Condition
healthy humans
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the non-inferiority between original product and development product on postprandial fat oxidation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fat oxidation amount of 60, 120, 180, 240 minutes later of test meal
Key secondary outcomes
Energy expenditure, respiratory quotient and carbohydrate oxidation amount of 60, 120, 180, 240 minutes later of test meal
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food A (one time) -> washout (more than 5 days) -> intake of test food B (one time) -> washout (more than 5 days) -> intake of test food C
Interventions/Control_2
Intake of test food A (one time) -> washout (more than 5 days) -> intake of test food C (one time) -> washout (more than 5 days) -> intake of test food A
Interventions/Control_3
Intake of test food B (one time) -> washout (more than 5 days) -> intake of test food A (one time) -> washout (more than 5 days) -> intake of test food C
Interventions/Control_4
Intake of test food B (one time) -> washout (more than 5 days) -> intake of test food C (one time) -> washout (more than 5 days) -> intake of test food A
Interventions/Control_5
Intake of test food C (one time) -> washout (more than 5 days) -> intake of test food A (one time) -> washout (more than 5 days) -> intake of test food B
Interventions/Control_6
Intake of test food C (one time) -> washout (more than 5 days) -> intake of test food B (one time) -> washout (more than 5 days) -> intake of test food A
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. Age<65 of healthy men and menopause women
2. 23<=BMI<30
3. provided written informed consent from subjects
Key exclusion criteria
1; No participation of all examination,
2; liver, kidney and heart disease, or disorder of respiration endocrine, metabolism, nervous system consciousness, or diabetes, or other diseases,
3; LDL-cholesterol>=140mg/dL, triglyceride>=150mg/dL, Systolic blood pressure>=140mmHg, diastolic pressure>=90mmHg, fastinf bloodglucose>=126mg/dL,
4; given medication or operation by severe sickness and injuly within 2 months before the trial,
5; medicine user for hyperglycaemia, lipidemiia, or hypertension,
6; user of supplements or foods with health claim
7; unpleasant feeling during blood drawing
8; donated 200 mL or more blood within l month before the trial,
9; smoker,
10; having allergy to the ingredients included in the test meal,
11; shift worker,
12; business trip or travel planned for 6 consecutive days or more during this trial
13; cannot fill in record of daily diet for 9 days (3 days x 3 times) ,
14; cannot allow operator to consult his/her data of the past health check,
15; participating subject of other clinical study or having a plan during this study period,
16; disagree with explanation for study,
17; judged to be inappropriate as subject by physician in charge
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Osaki |
Organization
Kao Corporation
Division name
Health Care Food Research Labs
Zip code
131-8501
Address
2-1-3 Bunka Sumida-ku Tokyo
TEL
03-5630-7224
osaki.noriko@kao.co.jp
Public contact
Name of contact person
| 1st name | Chizuka |
| Middle name | |
| Last name | Suzuki |
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
Homepage URL
suzuki.chizuka@kao.com
Sponsor or person
Institute
Kao Corporation
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
Oriental Ueno medical center
Address
1-20-11 Ueno Taito-ku Tokyo
Tel
03-5816-0711
info@tes-h.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
花王株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
The 95% confidence interval of difference of fat oxidation between A-001 and B-001 or C-001 were exceeded non-inferiority margin.
Results date posted
| 2019 | Year | 08 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy subjects
Participant flow
20 participants completed and 20 subjects were incorporated into the analyses
Adverse events
No adverse effect related to the test diets reported
Outcome measures
Fat oxidation amount of 60, 120, 180, 240 minutes later of test meal
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 02 | 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
| 2017 | Year | 01 | Month | 19 | Day |
Last modified on
| 2019 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028884
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
