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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043627
Receipt No. 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

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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
Email 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
Email sakai@tottori-u.ac.jp

Sponsor
Institute Department of Women's & Children's Family Nursing, Faculty of Medicine, Tottori University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049801

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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