UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043627 |
|---|---|
| Receipt number | R000049801 |
| Scientific Title | Improvement of sweet taste preference in patients with diabetes by new dietary therapy that changes taste perception |
| Date of disclosure of the study information | 2021/03/18 |
| Last modified on | 2021/03/16 14:38:17 |
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Basic information
Public title
Improvement of sweet taste preference in patients with diabetes by new dietary therapy that changes taste perception
Acronym
Improvement of sweet taste preference in patients with diabetes by new dietary therapy that changes taste perception
Scientific Title
Improvement of sweet taste preference in patients with diabetes by new dietary therapy that changes taste perception
Scientific Title:Acronym
Improvement of sweet taste preference in patients with diabetes by new dietary therapy that changes taste perception
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with diabetes may have difficulty with their dietary therapy due to a strong preference for sweet taste. We found that sweet taste preference was reduced by dietary guidance in some patients. However, there have been no reports about evaluation of dietary guidance methods with the focus on improvement of sweet taste preference.The purpose of this study was to clarify whether high intake of umami ingredients based on dietary guidance reduces sweetness preference and improves diabetic symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c and fasting plasma glucose before and after 12w interventions
Key secondary outcomes
Food intake by questionnaire, bowel movements and taste thresholds of 2 basic tastes (sweetness, umami)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Guidance food intake
Interventions/Control_2
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
| 25 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes attending the outpatient clinic of Hakuai Hospital, Japan who were on diet therapy only and who gave consent to the test.
Key exclusion criteria
When the person in charge of research determines that participation in this research is inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | Sakai |
Organization
School of Health Sciences, Faculty of Medicine, Tottori University
Division name
Department of Adult and Eldery Nursing
Zip code
683-8503
Address
86 Nishi-cho, Yonago 683-8503, Japan
TEL
0859-38-6317
sakai@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Chieko |
| Middle name | |
| Last name | Sakai |
Organization
School of Health Sciences, Faculty of Medicine, Tottori University
Division name
Department of Adult and Eldery Nursing
Zip code
683-8503
Address
86 Nishi-cho, Yonago 683-8503, Japan
TEL
0859-38-6317
Homepage URL
sakai@tottori-u.ac.jp
Sponsor or person
Institute
Department of Women's & Children's Family Nursing, Faculty of Medicine, Tottori University
Institute
Department
Personal name
Funding Source
Organization
JSPS Grant-in-Aid
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Health Sciences, Faculty of Medicine, Tottori University
Address
86 Nishi-cho, Yonago 683-8503, Japan
Tel
0859-38-6317
sakai@tottori-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
| 2021 | Year | 03 | Month | 18 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 03 | Month | 16 | Day |
Last modified on
| 2021 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049801
| Research Plan | |
|---|---|
| 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 |
