UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of making one meal a vegetarian diet : a randomized, open-label study
Acronym	Vege-One Diet study
Scientific Title	Efficacy of making one meal a vegetarian diet : a randomized, open-label study
Scientific Title:Acronym	Vege-One Diet study
Region	Japan

Condition
Condition	lifestyle diseases
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study considers whether the meal that makes one meal of vegetarian food contribute to an increase in the intake of vegetables and improvement of risk factors for lifestyle diseases as compared with standard meals.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of vegetable intake, lifestyle disease risk factors at 3 months after intervention.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	1 meal a day (lunch) vegetable 350 g or more (dietary fiber 10 g or more), 3 months
Interventions/Control_2	Standard meal based on conventional ingestion criteria
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Persons who are 20 years old or more and under 65 years old 2) Persons who obtained consent by the document (proxy agreement is not possible)
Key exclusion criteria	1) Persons who are undergoing treatment for diabetes 2) Persons who take warfarin 3) Persons who have renal dysfunction (serum Cr> 1.3 mg / dL males, > 1.2 mg / dL female) 4) Persons who are pregnant, breastfeeding, scheduled or hoping to be pregnant during the exam period 5) Persons whose eligibility for this study is not appropriate by other reasons.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Eita Middle name Last name Nishimori
Organization	Asama General Hospital
Division name	Department of Diabetes Medicine
Zip code	3850022
Address	1862-1 Iwamurada, Saku, Nagano, JAPAN
TEL	0267-67-2295
Email	eita-nishimori@umin.ac.jp

Public contact
Name of contact person	1st name Eita Middle name Last name Nishimori
Organization	Asama General Hospital
Division name	Department of Diabetes Medicine
Zip code	3850022
Address	1862-1 Iwamurada, Saku, Nagano, JAPAN
TEL	0267-67-2295
Homepage URL
Email	eita-nishimori@umin.ac.jp

Sponsor
Institute	Asama General Hospital
Institute
Department

Funding Source
Organization	Asama General Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Asama General Hospital
Address	1862-1 Iwamurada, Saku, Nagano, JAPAN
Tel	0267-67-2295
Email	asama-soumu@city.saku.nagano.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	佐久市立国保浅間総合病院

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 02 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	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 23 Day
Date of IRB	2018 Year 04 Month 02 Day
Anticipated trial start date	2018 Year 04 Month 02 Day
Last follow-up date	2018 Year 11 Month 30 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 04 Month 02 Day
Last modified on	2020 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036446