UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory study to evaluate the efficacy of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation
Acronym	The effect of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation
Scientific Title	An exploratory study to evaluate the efficacy of enteral nutrition using thickening agents on physical properties in stomach and blood glucose fluctuation
Scientific Title:Acronym	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	1st name Middle name Last name Hideaki Mizuno
Organization	Mejiro Second General Hospital
Division name	Department of Surgery
Zip code
Address	1980, Hussa, Hussa, Tokyo, 197-0011, Japan
TEL	042-553-3511
Email	zbm05143@sky.zero.ad.jp

Public contact
Name of contact person	1st name Middle name Last name Hideaki Mizuno
Organization	Mejiro Second General Hospital
Division name	Department of Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	Completed
Date of protocol fixation	2018 Year 11 Month 22 Day
Date of IRB	2018 Year 11 Month 22 Day
Anticipated trial start date	2018 Year 12 Month 03 Day
Last follow-up date	2019 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	2018 Year 12 Month 03 Day
Last modified on	2019 Year 06 Month 04 Day

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