UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041223 |
|---|---|
| Receipt number | R000047045 |
| Scientific Title | Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2024/04/06 21:25:35 |
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Basic information
Public title
Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition
Acronym
Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition
Scientific Title
Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition
Scientific Title:Acronym
Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether dietary habits are actually improved by taking a variety of food products 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 level accompany eating
Key secondary outcomes
Subjective and Objective sleep quality
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects are attached Free Style Libre for monitoring brood glucose level.At the same time, the subjects are attached Fitbit for monitoring sleep quality. (2 weeks)
1) Eat test meal as asnacks.
Interventions/Control_2
2) Eat glucose as asnacks.
Interventions/Control_3
3) Eat test meal after dinner.
Interventions/Control_4
4) Do not eat between snacks.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Healthy adults over 19 years of age
2.A subject who related of a school in Aikoku Gakuen Junior College
3.The subject who provided written consent for participation
Key exclusion criteria
1.The subject that cannot cooperate in response to explanation of this examination.
2.The Subject more than BMI 30.
3.The subject whose supervisors judged participation to be inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Hirao |
Organization
Aikoku Gakuen Junior College
Division name
Department of Home Economics
Zip code
133-8585
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL
03-5668-7260
hirao@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
133-8585
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL
03-5668-7260
Homepage URL
a.furutani@kurenai.waseda.jo
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
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
| 2020 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://jscholarpublishers.com/articles/JFN/Taking-Fruit-Granola-as-a-Snacks.pdf
Number of participants that the trial has enrolled
38
Results
The fruit granola snack significantly suppressed the increase in postprandial glucose level at the time of snack consumption compared with the glucose snack
The postprandial glucose rise with dinner was significantly suppressed in the fruit granola snack group compared with groups G, N and A
A significantly lower number of awakenings occurred during sleep in the fruit granola snack group than in groups N and A (no snack)
Results date posted
| 2024 | Year | 04 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No adverse events were reported.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2020 | Year | 07 | Month | 27 | 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=R000047045
