UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057086 |
|---|---|
| Receipt number | R000065166 |
| Scientific Title | Association Between Enterotype and the Post-Dinner Glucose-Lowering Effect of Afternoon Barley Intake |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2026/03/03 15:05:58 |
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Basic information
Public title
Association Between the Type of Gut Microbiota and the Post-Dinner Glucose-Lowering Effect of Afternoon Barley Intake
Acronym
Association Between the Type of Gut Microbiota and the Post-Dinner Glucose-Lowering Effect of Afternoon Barley Intake
Scientific Title
Association Between Enterotype and the Post-Dinner Glucose-Lowering Effect of Afternoon Barley Intake
Scientific Title:Acronym
Association Between Enterotype and the Post-Dinner Glucose-Lowering Effect of Afternoon Barley Intake
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relationship between enterotype and the effect of consuming barley as an evening snack on suppressing post-dinner blood glucose rise, and to verify the effect on blood glucose fluctuation the next day.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glucose level increase after dinner
Key secondary outcomes
Changes in glucose levels the day after barley intake
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
150 g of rice containing 50% barley
Interventions/Control_2
150 g of white rice
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
Women aged between 18 and 29 years old
Key exclusion criteria
Smokers
Midnight worker
BMI of 25 or higher
Habitual supplement intake
Metabolic disorders
Familial hypercholesterolemia
Internal use of the adrenal cortex hormone
Person with the food allergy to offer planned food
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Hokimoto |
Organization
Tenshi College
Division name
Graduate School of Nursing and Nutrition, Division of Nutrition Management, Doctoral Program, Master Cource
Zip code
065-0013
Address
1-30, Higashi 3-chome, Kita 13-jo, Higashi-ku, Sapporo-shi , Hokkaido
TEL
011-741-1051
20248104@student.tenshi.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Hokimoto |
Organization
Tenshi College
Division name
Graduate School of Nursing and Nutrition, Division of Nutrition Management, Master Cource
Zip code
065-0013
Address
1-30, Higashi 3-chome, Kita 13-jo, Higashi-ku, Sapporo-shi , Hokkaido
TEL
011-741-1051
Homepage URL
20248104@student.tenshi.ac.jp
Sponsor or person
Institute
Tenshi College
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tenshi College
Address
1-30, Higashi 3-chome, Kita 13-jo, Higashi-ku, Sapporo-shi , Hokkaido
Tel
011-741-1051
20248104@student.tenshi.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
天使大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 20 | 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
30
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
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 11 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 12 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 07 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065166
