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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030002
Receipt No. R000034262
Scientific Title Suppressive effect of test food on the postprandial triglyceride level -A randomized, open-label, cross-over study-
Date of disclosure of the study information 2017/11/22
Last modified on 2018/05/28

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Basic information
Public title Suppressive effect of test food on the postprandial triglyceride level -A randomized, open-label, cross-over study-
Acronym Suppressive effect of test food on the postprandial triglyceride level
Scientific Title Suppressive effect of test food on the postprandial triglyceride level -A randomized, open-label, cross-over study-
Scientific Title:Acronym Suppressive effect 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 blood triglyceride level of subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Area under the curve for serum triglyceride level
Key secondary outcomes Fasting serum triglyceride level, serum triglyceride levels of 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 Open -no one is blinded
Control No treatment
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 Ingestion of test food, and then without ingestion of test food after wash out period.
Interventions/Control_2 Without ingestion of test food, 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) Subjects who 20 to 64 years of age.
2) Subjects whose fasting serum triglyceride levels are less than 200 mg/dL.
3) Subjects who can respond to the study schedule including accommodation.
4) Subjects who agree to participate in the study and who can sign, seal and date the consent forms themselves.
Key exclusion criteria 1) Subjects who routinely use medicine related to lipid metabolism.
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 test food and/or high fat meal and have extreme lactose intolerance or diarrhea.
4) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
5) Heavy user of alcohol or excessive smokers.
6) Subjects who are judged as unsuitable for the study by the doctor.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jyouji Kurokawa
Organization Medical Corporation Shoureikan Sinsapporo seiryou Hospital
Division name General Clinical Department
Zip code
Address 2-1-30, Atsubetsuhigashi 4jo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL 011-898-2151
Email j.kurokawa@shoureikan.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isao Takehara
Organization Clinical Support Corporation Limited
Division name Food Service Division
Zip code
Address 4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-223-3130
Homepage URL
Email takehara@csc-smo.co.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
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 医療法人社団翔嶺館新札幌聖陵ホスピタル(北海道)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 22 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
2017 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 22 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
2017 Year 11 Month 16 Day
Last modified on
2018 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034262

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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