UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032071 |
|---|---|
| Receipt number | 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 00:46:49 |
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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
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
eita-nishimori@umin.ac.jp
Sponsor or person
Institute
Asama General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036446
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
