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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036737
Receipt No. R000041856
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 2019/05/16
Last modified on 2019/05/14

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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 Adult men and women
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 Confirmatory
Trial characteristics_2 Explanatory
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 Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of test food (single ingestion) - washout period - intake of placebo (single ingestion).
Interventions/Control_2 Intake of placebo (single ingestion) - washout period - intake of test food (single ingestion).
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 60

Research contact person
Name of lead principal investigator
1st name Hideaki
Middle name
Last name Hoshino
Organization Medical Corporation Jikokai Shiroishi Internal Medicine Clinic
Division name General Medicine Clinical Departments Internal Medicine Respiratory Medicine Allergy
Zip code 003-0011
Address 7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL 011-868-2711
Email shiroishi@jikkai.or.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Suzuki
Organization Medical Corporation Jikokai
Division name Clinical Trial Division
Zip code 003-0011
Address 7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL 011-868-2711
Homepage URL
Email suzuki-jikoukai@e-mail.jp

Sponsor
Institute FANCL Corporation
Institute
Department

Funding Source
Organization FANCL Corporation
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 Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Institutional Review Board
Address Ito-Yokado Fukuzumi 5F, 1-2-5 Fukuzumi-2 jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel 011-836-3531
Email fukui@mediks.jp

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
2019 Year 05 Month 16 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 13 Day
Date of IRB
2019 Year 05 Month 13 Day
Anticipated trial start date
2019 Year 06 Month 06 Day
Last follow-up date
2019 Year 06 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 14 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041856

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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