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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035110
Receipt No. R000040017
Official scientific title of the study An exploratory study to evaluate the efficacy of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation
Date of disclosure of the study information 2018/12/03
Last modified on 2018/12/03

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Basic information
Official scientific title of the study An exploratory study to evaluate the efficacy of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation
Title of the study (Brief title) The effect of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Gastroenterology Endocrinology and Metabolism Gastrointestinal surgery
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose level
Key secondary outcomes Physical properties in stomach

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Novel enteral nutrition using thickening agents VVT-01
Interventions/Control_2 Liquid enteral nutrition
Interventions/Control_3 Commercially available enteral nutrition using thickening agents
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
64 years-old >=
Gender Male and Female
Key inclusion criteria aged 20-64 years
Key exclusion criteria 1.Subject who are pregnant or under lactation, or expected to be pregnant during the study
2.Subjects who have serious history or receiving treatment of liver, kidney, heart, lung, digestive, hematological and metabolic disease
3.Subjects who are chronic disease
4.Subjects who have history of serious food or drug allergy
5.Subjects who have fasting blood glucose 69>= or 100<=
6.Subjects who have HbA1c 4.5>= or 5.6<=
7.Subjects who are planning to participate in the other study during the study period
8.Subjects judged inappropriate for the study by the principal investigator
Target sample size 6

Research contact person
Name of lead principal investigator Hideaki Mizuno
Organization Mejiro Second General Hospital
Division name Department of Surgery
Address 1980, Hussa, Hussa, Tokyo, 197-0011, Japan
TEL 042-553-3511
Email zbm05143@sky.zero.ad.jp

Public contact
Name of contact person Hideaki Mizuno
Organization Mejiro Second General Hospital
Division name Department of Surgery
Address 1980, Hussa, Hussa, Tokyo, 197-0011, Japan
TEL 042-553-3511
Homepage URL
Email zbm05143@sky.zero.ad.jp

Sponsor
Institute Mejiro Second General Hospital
Institute
Department

Funding Source
Organization MORINAGA MILK INDUSTRY CO.
Organization
Division
Category of Funding Organization Profit organization
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 12 Month 03 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 22 Day
Anticipated trial start date
2018 Year 12 Month 03 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 12 Month 03 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040017

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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