UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050442 |
|---|---|
| Receipt number | R000057430 |
| Scientific Title | A randomized controlled trial on the effects of high-amylose rice porridge intake on swallowability and postprandial blood glucose levels in healthy subjects |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/11/16 21:49:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A randomized controlled trial on the effects of high-amylose rice porridge intake from Ehime Prefecture on swallowability and postprandial blood glucose levels in healthy subjects
Acronym
A randomized controlled trial on the effects of high-amylose rice porridge intake on swallowability and postprandial blood glucose levels in healthy subjects
Scientific Title
A randomized controlled trial on the effects of high-amylose rice porridge intake on swallowability and postprandial blood glucose levels in healthy subjects
Scientific Title:Acronym
A randomized controlled trial on the effects of postprandial high-amylose rice porridge intake on swallowability and blood glucose levels
Region
| Japan |
Condition
Condition
swallowability, postprandial glucose level
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidating the swallowability and postprandial blood glucose level of high-amylose rice porridge intake will lead to the provision of a wide range of food choices for elderly diabetic patients.
Therefore, the aim of this randomized clinical trial in healthy subjects is to examine the effect of rice porridge of high-amylose rice "Hoshinishiki" intake on swallowability and postprandial blood glucose.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Swallow pressure and time, laryngeal residue, number of swallows
Key secondary outcomes
(incremental) the area under the curve of postprandial glucose level
Subjective hunger and satiety, sensory properties
Meal taste scores (appearance, smell, taste, aftertaste, and overall taste), subjective evaluation of physical properties in the mouth and during swallowing
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
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
Test for postprandial glucose level: the 632.9 g high-amylose rice porridge
Test for swallowability:
10 g high-amylose rice porridge (20 degree centigrade) per serving (3 times)
10 g high-amylose rice porridge (45 degree centigrade) per serving (3 times)
Interventions/Control_2
Test for postprandial glucose level: the 588.2 g control rice porridge.
Test for swallowability:
10 g control rice porridge (20 degree centigrade) per serving (3 times)
10 g control rice porridge (45 degree centigrade) per serving (3 times)
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who do not have swallowing ability problems.
Key exclusion criteria
1. Persons who are pregnant or breastfeeding, has an allergic reaction to rice and metal, or wear a pacemaker
2. Persons with swallowing problems (score of 3 points or higher on the EAT-10 swallowing screening tool)
3. Persons who are not suitable judged by medical doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koutatsu |
| Middle name | |
| Last name | Maruyama |
Organization
Ehime University
Division name
Graduate School of Agriculture
Zip code
7908566
Address
3-5-7 Tarumi, Matsuyama, Ehime
TEL
089-946-9960
maruyama.kotatsu.rt@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Koutatsu |
| Middle name | |
| Last name | Maruyama |
Organization
Ehime University
Division name
Graduate School of Agriculture
Zip code
7908566
Address
3-5-7 Tarumi, Matsuyama, Ehime
TEL
089-946-9960
Homepage URL
maruyama.kotatsu.rt@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Koutatsu Maruyama
Funding Source
Organization
Self-funding
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
Ehime University
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5040
rinri@m.ehime-u.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 | 03 | Month | 01 | 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
Suspended
Date of protocol fixation
| 2022 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057430
