UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048192 |
|---|---|
| Receipt number | R000054921 |
| Scientific Title | Examination of GI changes during ingestion of processed oats in chrono-nutrition |
| Date of disclosure of the study information | 2022/06/29 |
| Last modified on | 2024/04/06 12:02:48 |
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Basic information
Public title
Examination of GI changes during ingestion of processed oats in chrono-nutrition
Acronym
Examination of GI changes during ingestion of processed oats in chrono-nutrition
Scientific Title
Examination of GI changes during ingestion of processed oats in chrono-nutrition
Scientific Title:Acronym
Examination of GI changes during ingestion of processed oats in chrono-nutrition
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine GI measurement of processed oats and its effect on second and third meal effects, based on chrono-nutrition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of blood glucose levels
Key secondary outcomes
Change of glucose in interstitial fluid
Change of blood insulin levels
Change of blood GLP-1 levels
Change of lipid-related item levels
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Eat rice at breakfast
Interventions/Control_2
Eat fruit granola at breakfast
Interventions/Control_3
Eat baked oatmeal at breakfast
Interventions/Control_4
Eat oats at breakfast
Interventions/Control_5
No eat breakfast
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) healthy persons aged 18 years and older
(2) persons who provided written consent for participation.
Key exclusion criteria
(1) individuals who were allergic to the food used in the study
(2) individuals with glucose intolerance (abnormal at medical examination for the past 2 years)
(3) individuals with a fasting blood glucose of >110 mg/dL
(4) individuals with a Body Mass Index (BMI) of >30
(5) patients with severe liver disease, kidney disease, heart disease, lung disease, psychiatric disease, blood disease, etc.
(6) individuals who took drugs such as antihypertensive drugs
(7) those who wished to become pregnant, or were pregnant/breastfeeding during the study
(8) those who were judged by the study supervisor to be inappropriate for participation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Furutani |
Organization
Aikoku Gakuen Junior College
Division name
Department of Home Economics
Zip code
1338585
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL
03-5668-7260
furutani@aikoku-jc.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Furutani |
Organization
Aikoku Gakuen Junior College
Division name
Department of Home Economics
Zip code
1338585
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL
03-5668-7260
Homepage URL
furutani@aikoku-jc.ac.jp
Sponsor or person
Institute
Aikoku Gakuen Junior College
Institute
Department
Personal name
Funding Source
Organization
Calbee, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Waseda University, Graduate school of advanced science and engineering, Department of electrical engineering and bioscience.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aikoku Gakuen Junior College
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
Tel
03-5668-7260
aioffice@aikoku-jc.ac.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
| 2022 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054921
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
