UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of eating vegetables and mushroom before carbohydrates on postprandial lipemia: A randomized, double-blind, cross-over, controlled trial.
Title of the study (Brief title)	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	Shin Sukino
Organization	Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name	Division of Preventive Medicine
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	Shin Sukino
Organization	Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name	Division of Preventive Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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