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Recruitment status Completed
Unique ID issued by UMIN UMIN000019709
Receipt No. R000022765
Scientific Title Study of continuous vegetable intake and effective vegetable intake method on the lipid metabolism of the men
Date of disclosure of the study information 2015/11/09
Last modified on 2015/11/26

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Basic information
Public title Study of continuous vegetable intake and effective vegetable intake method on the lipid metabolism of the men
Acronym vegetable intake and serum lipid
Scientific Title Study of continuous vegetable intake and effective vegetable intake method on the lipid metabolism of the men
Scientific Title:Acronym vegetable intake and serum lipid
Region
Japan

Condition
Condition Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study of lipid metabolism and various parameters by a continuous vegetable intake.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood (Glucose, Hemoglobin A1c, Triacylglycerol, Free fatty acid, T-Chol, HDL-Chol, LDL-Chol, Insulin, Vitamin C, Leptin, Adiponectin, HOMA-IR, Arteriosclerotic Index)
Key secondary outcomes Anthropometry (Height, Weight, Body fat percentage, BMI, Waist circumference), Blood pressure, Food intake

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 vegetable and fruit juice (4weeks)
Interventions/Control_2 raw vegetable and fruit juice (4weeks)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
59 years-old >=
Gender Male
Key inclusion criteria Obtained written informed consent from the men before the participation
Key exclusion criteria Those who felt this study was inconvenient to everyday life.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiko Kuwano
Organization University of Shizuoka
Division name School of Food and Nutritional Sciences
Zip code
Address 52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan
TEL 054-264-5513
Email kuwano@u-shizuoka-ken.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiko Kuwano
Organization University of Shizuoka
Division name School of Food and Nutritional Sciences
Zip code
Address 52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan
TEL 054-264-5513
Homepage URL
Email kuwano@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization University of Shizuoka
Organization
Division
Category of Funding Organization Local Government
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
2015 Year 11 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 09 Day
Last modified on
2015 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022765


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