UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052356 |
|---|---|
| Receipt number | R000059641 |
| Scientific Title | Dietary Intake Methods to Prevent Postprandial Sleepiness in Healthy Adults: A Crossover Comparison Study |
| Date of disclosure of the study information | 2023/09/30 |
| Last modified on | 2024/03/30 14:00:23 |
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Basic information
Public title
Dietary Intake Methods to Prevent Postprandial Sleepiness in Healthy Adults: A Crossover Comparison Study
Acronym
Dietary Intake Methods to Prevent Postprandial Sleepiness in Healthy Adults: A Crossover Comparison Study
Scientific Title
Dietary Intake Methods to Prevent Postprandial Sleepiness in Healthy Adults: A Crossover Comparison Study
Scientific Title:Acronym
Dietary Intake Methods to Prevent Postprandial Sleepiness in Healthy Adults: A Crossover Comparison Study
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effectiveness of ingestion methods on alleviating postprandial sleepiness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of sleepiness using the Stanford Sleepiness Scale
Key secondary outcomes
Assessment using NRS with respect to post-meal satisfaction, hunger, and appetite
Assessment of blood glucose levels using FreeStyle Libre and evaluation of blood glucose
fluctuations
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intervention group. At lunch, participants will eat ramen topped with cabbage.
Interventions/Control_2
Control group. At lunch, eat ramen without cabbage topping
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
Male and Female
Key inclusion criteria
Those who have received sufficient explanation about the purpose and contents of this research, have the ability to consent, volunteered voluntarily after fully understanding, and agreed to participate in writing.
Key exclusion criteria
Volunteers will be excluded from study participation if they:
1) refuse to participate in the study;
2) Those who cannot distinguish tastes.
3) Those who are taking sleeping pills
4) Those taking sleeping pills
5) Those taking hypoglycemic medication
6) Those who are habitual smokers
7) Patients with diabetes mellitus
8) Those who are not feeling well on the day
9)People who have any contraindications to the "FreeStyle Libre" sensor
(Those who are scheduled to undergo an MRI scan during the study period,Those who are using a glucose monitoring device from another company,Those who use other implantable medical devices such as pacemakers, etc.)
10) Those who are judged to be ineligible by the principal investigator.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
n-wakui@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
Homepage URL
n-wakui@hoshi.ac.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
Funding Source
Organization
Hoshi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hoshi University Research Ethics Committee
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
Tel
03-3786-1011
y-hashiguchi@hoshi.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
| 2023 | Year | 09 | Month | 30 | 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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2023 | Year | 09 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059641
