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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032071
Receipt No. R000036446
Scientific Title Efficacy of making one meal a vegetarian diet : a randomized, open-label study
Date of disclosure of the study information 2018/04/02
Last modified on 2020/10/05

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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/ctr_e/ctr_view.cgi?recptno=R000036446

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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