UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032752 |
|---|---|
| Receipt number | R000037354 |
| Scientific Title | Suppressive effect of test food on the postprandial triglyceride level -A randomized, double blind, placebo controlled, cross-over study- |
| Date of disclosure of the study information | 2018/05/29 |
| Last modified on | 2018/10/05 18:49:47 |
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Basic information
Public title
Suppressive effect of test food on the postprandial triglyceride level -A randomized, double blind, placebo controlled, cross-over study-
Acronym
Suppressive effect of combination of test food on the postprandial triglyceride level
Scientific Title
Suppressive effect of test food on the postprandial triglyceride level -A randomized, double blind, placebo controlled, cross-over study-
Scientific Title:Acronym
Suppressive effect of combination of test food on the postprandial triglyceride level
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of test food on the postprandial triglyceride level of subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Area under the curve for postprandial serum triglyceride level
Key secondary outcomes
Area under the curve for Remnant-like particle cholesterol, and serum triglyceride levels and Remnant-like particle cholesterol of before, 2, 3, 4 and 6 hours after high fat meal ingestion.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food, and then ingestion of placebo after wash out period.
Interventions/Control_2
Intake of placebo, and then ingestion of test food after wash out period.
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)Males and females 20 to 64 years of age.
2)Subjects whose fasting serum triglyceride levels are less than 200 mg/dL.
Key exclusion criteria
1)Subjects who has serious medical history or who had digestive tract resection surgery.
2)Subjects who routinely use medicine, supplements, FOSHU and/or health food which affect to result of the study.
3)Subjects who have allergy to the test food or high fat meal and have extreme lactose intolerance or diarrhea.
4)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating.
5) Heavy use of alcohol or excessive smokers
6) Subjects who is considered to be inappropriate to attend the present study by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Hoshino |
Organization
Medical Corporation Jikokai Shiroishi Internal Medicine Clinic
Division name
General Medicine Clinical Departments Internal Medicine Respiratory Medicine Allergy
Zip code
Address
7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL
011-868-2711
shiroishi@jikkai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Suzuki |
Organization
Medical Corporation Jikokai
Division name
Clinical Trial Division
Zip code
Address
7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL
011-868-2711
Homepage URL
suzuki-jikoukai@e-mail.jp
Sponsor or person
Institute
FANCL Corporation
Research Institute
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
医療法人社団 慈昂会 白石内科クリニック
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 29 | 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 | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 11 | 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 | 05 | Month | 29 | Day |
Last modified on
| 2018 | 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=R000037354
