UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024510 |
|---|---|
| Receipt number | R000028166 |
| Scientific Title | Effect of cereal-derived processed product on metabolism :a randomized, double-blind, crossover study |
| Date of disclosure of the study information | 2016/10/24 |
| Last modified on | 2019/08/26 13:55:32 |
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Basic information
Public title
Effect of cereal-derived processed product on metabolism :a randomized, double-blind, crossover study
Acronym
Effect of cereal-derived processed product on metabolism
Scientific Title
Effect of cereal-derived processed product on metabolism :a randomized, double-blind, crossover study
Scientific Title:Acronym
Effect of cereal-derived processed product on metabolism
Region
| Japan |
Condition
Condition
healthy humans
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of cereal-derived processed product on metabolism, and clarify its mechanism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fat oxidation
Key secondary outcomes
Serum glucose-dependent insulinotropic polypeptide and insulin.
Energy expenditure
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of control food (one time)
Interventions/Control_2
Intake of test food (one time)
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
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; suffering from liver, kidney, heart disease, disorder respiration endocrine, metabolism, nervous system consciousness, diabetes, or other diseases
2; LDL-cholesterol>=140mg/dL, triglyceride>=150mg/dL, Systolic blood pressure>=140mmHg, diastolic pressure>=90mmHg, fasting blood glucose>=126mg/dL,
3; taking medication or operation by severe sickness and injury within 2 months before the trial,
4; becoming unpleasant feeling after blood test or energy expenditure analyzing (metabolic chamber, collecting of breath by mask or hood)
5; making blood donation of 200 mL or more within l month of this trial
6; medicine user for hyperglycemia, hyperlipidemia, or hypertension,
7; unstable measurement of energy expenditure
8; heavy drinker(more than 30 g/day alcohol everyday)
9; user of supplements or foods with health claim
10; having variability in body weight more than +-2.0 kg within 1 month of this trial
11; business trip or travel planned for 5 consecutive days or more during this trial
12; having allergy to gum
13; having allergy to the ingredients included in the test meal
14; smoker
15; participating subject of other clinical study or having a plan during this study period,
16; judged to be inappropriate for the study based on the access record by medical doctor.
17; judged to be inappropriate as subject by physician in charge
Target sample size
15
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.co.jp
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
Kao Corporation Human Research IRB
Address
2-1-3 Bunka Sumida-ku Tokyo
Tel
+81-3-5630-7263
morisaki.naoko@kao.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 | 10 | Month | 24 | 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
works in progress
Number of participants that the trial has enrolled
22
Results
Significant difference in the primary outcome
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
21 participants completed and 21 subjects were incorporated into the analyses
Adverse events
No adverse effect related to the test diets reported
Outcome measures
Postprandial fat oxidation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 14 | 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 | 10 | Month | 21 | 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=R000028166
