UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031604 |
|---|---|
| Receipt number | 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 12:51:47 |
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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
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
cocoro@softpratica.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
