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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034675
Receipt No. R000039398
Official scientific title of the study Short-term intake of the high-amylose rice (Ehime Prefecture grown) in inpatients with diabetes mellitus: A non-randomized clinical trial.
Date of disclosure of the study information 2018/11/05
Last modified on 2018/10/28

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Basic information
Official scientific title of the study Short-term intake of the high-amylose rice (Ehime Prefecture grown) in inpatients with diabetes mellitus: A non-randomized clinical trial.
Title of the study (Brief title) Intervention study of high-amylose rice intake in inpatients with diabetes mellitus.
Region
Japan

Condition
Condition Diabetes mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is highly useful that study of the functional rice in dietetic therapy.
Thus, the objective of this study is to examins the effect of high-amylose rice on postprandial continuous glucose levels and rice preferences.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Continuous glucose monitoring data after rice intake: glycemic fluctuation, postprandial blood glucose, hypoglycemia, nocturnal blood glucose
Key secondary outcomes Amount of dietary intake, rice preferences

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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The high-amylose rice is applied for 3 days and the normal rice is applied for 4 days
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
20 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria The Ehime University Hospital's in-patients with diabetes mellitus who are 20 to 74 years old and the BMI is from 18.5 to 29.9kg/m2
Key exclusion criteria 1. The persons who are in the treatment of malignant neoplasm, ischemic heart disease, cerebrovascular disease, chronic kidney disease, dementia or severe digestive system disease.
2. The person in the period of pregnancy and lactation.
3. The patients who are unsuited to participate the study.
Target sample size 35

Research contact person
Name of lead principal investigator Koutatsu Maruyama
Organization Ehime University
Division name Laboratory of Community Health and Nutrition, Special Course of Food and Health Science Department of Bioscience, Graduate School of Agriculture
Address 3-5-7 Tarumi, Matsuyama, Ehime
TEL 089-946-9960
Email maruyama.kotatsu.rt@ehime-u.ac.jp

Public contact
Name of contact person Koutatsu Maruyama
Organization Ehime University
Division name Laboratory of Community Health and Nutrition, Special Course of Food and Health Science Department o
Address 3-5-7 Tarumi, Matsuyama, Ehime
TEL 089-946-9960
Homepage URL
Email maruyama.kotatsu.rt@ehime-u.ac.jp

Sponsor
Institute Ehime University
Institute
Department

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)

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
2018 Year 11 Month 05 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 08 Month 03 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 10 Month 28 Day
Last modified on
2018 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039398

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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