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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031604
Receipt No. R000035899
Scientific Title Effect of eating vegetables and mushroom before carbohydrates on postprandial lipemia: A randomized, double-blind, cross-over, controlled trial.
Date of disclosure of the study information 2018/03/06
Last modified on 2018/09/27

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Basic information
Public title Effect of eating vegetables and mushroom before carbohydrates on postprandial lipemia:
A randomized, double-blind, cross-over, controlled trial.
Acronym Effect of eating vegetables and mushroom before carbohydrates on postprandial lipemia:
A randomized, double-blind, cross-over, controlled trial.
Scientific Title Effect of eating vegetables and mushroom before carbohydrates on postprandial lipemia:
A randomized, double-blind, cross-over, controlled trial.
Scientific Title:Acronym Effect of eating vegetables and mushroom before carbohydrates on postprandial lipemia:
A randomized, double-blind, cross-over, controlled trial.
Region
Japan

Condition
Condition Healthy subjects
Patients with diabetes
Patients with dyslipidemia
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the effect of eating vegetables and mushroom before carbohydrates on postprandial lipemia in a cross over study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in blood TG levels
Key secondary outcomes Changes in blood glucose, N-carboxymethyl lysine levels and body temperature

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Meal diet (Vegetable first)
Interventions/Control_2 Meal diet (Vegetable second)
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
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Age: 18-80 years
2) Male or Female
3) Provided written consent to participate in this study
Key exclusion criteria 1) Any of the following serious diseases or disorders:
cardiovascular, hematological, respiratory, gastrointestinal, endocrine, central nervous system, psychiatric, or cancer
2) Currently hospitalized
3) Heavy alcohol intake (>= 60g of alcohol)
4) Shift or night-shift worker
5) Ongoing participation in other clinical trials or research
6) Being declared unsuitable for the study through medical examination by a doctor
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Sukino
Organization Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name Division of Preventive Medicine
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL +81-75-641-9161
Email cocoro@softpratica.com

Public contact
Name of contact person
1st name
Middle name
Last name Shin Sukino
Organization Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name Division of Preventive Medicine
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL +81-75-641-9161
Homepage URL
Email cocoro@softpratica.com

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization Japanese Governmental office
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 03 Month 06 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 01 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 02 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
2018 Year 03 Month 06 Day
Last modified on
2018 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035899

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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