UMIN-CTR Clinical Trial

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