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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029484
Receipt No. R000033639
Scientific Title A clinical study for evaluating of the effect of a complex food on postprandial serum triglyceride.
Date of disclosure of the study information 2018/11/29
Last modified on 2019/03/05

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Basic information
Public title A clinical study for evaluating of the effect of a complex food on postprandial serum triglyceride.
Acronym Clinical study for the effect on TG
Scientific Title A clinical study for evaluating of the effect of a complex food on postprandial serum triglyceride.
Scientific Title:Acronym Clinical study for the effect on TG
Region
Japan

Condition
Condition Healthy subjects with slightly higher fasting serum triglyceride level
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of the complex food on postprandial serum triglyceride(TG) and the safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The differences of serum TG level at sequential sampling point and AUC 0-6h between placebo and test food groups (The analysis of the actual measured values and the amount of changed values from baseline after the loading dietary fat)
Key secondary outcomes The differences of serum level of remnant-like lipoprotein cholesterol at sequential sampling point and AUC 0-6h between placebo and test food groups (The analysis of the actual measured values and the amount of changed values from baseline after the loading dietary fat)
Assessment of safety (subjective and objective symptoms and blood chemistry).

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 single ingestion of the placebo food - washout period (6 days or more) - single ingestion of the test food
Interventions/Control_2 single ingestion of the test food - washout period (6 days or more) - single ingestion of the placebo food
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)Japanese males and females from 20 to 64 years of age when consented.
(2)Healthy subjects whose fasting serum TG levels is slightly high at pre-, 1st and 2nd screenings and whose time courses of serum TG after loading dietary food resemble each other at 1st and 2nd screening.
(3)Subjects available at every designated visit.
(4)Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria (1) Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases.
(2) Subjects with a surgical history of digestive system (except appendicectom).
(3) Subjects with a history of a previous drug or food allergy.
(4) Subjects currently under treatment with chronic diseases.
(5) Subjects who are pregnant or intend to become pregnant during the study or are lactating.
(6) Subjects who are lactose intolerant or sensitive to fatty diet to show gastrointestinal symptoms.
(7) Subjects who take excessive alcohol (equivalent to 540 mL of Japanese sake or more) for 5 days or more per week.
(8) Subjects who take drugs or supplements which claim the suppressive absorption of sugar or lipid or reduction of triglyceride, etc.
(9) Subjects who participate in other clinical trial.
(10) Subjects who have a history of feeling ill or unwell during or after blood drawing.
(11) Subjects who have donated over 200 mL of blood within the last one month prior to this study or expect to donate the same during the study.
(12) Subjects with extremely irregular dietary life (shift worker, night- shift worker, etc.)
(13) Subjects who had excessive eating and/or drinking during 3 days prior to each screening or prior to intervention period I or II.
(14) Subjects who fasted repeatedly during 3 days prior to each screening or prior to intervention period I or II.
(15) Subject who had excessive exercise than usual during 3 days prior to each screening or prior to intervention period I or II.
(16) Subjects judged as unsuitable for this study by the investigator for other reasons.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jyoji Kurokawa
Organization Iryouhoujinsyadan Shoureikan
Division name Shinsapporo Seiryou Hospital
Zip code
Address 2-1-30, Atsubetsuhigashi 4-jo, Atsubetsu-ku Sapporo city, Hokkaido, 004-0004, Japan
TEL 011-898-2151
Email j.kurokawa@shoureikan.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Kanamori
Organization Iryouhoujinsyadan Shoureikan
Division name Shinsapporo Seiryou Hospital
Zip code
Address 22-1-30, Atsubetsuhigashi 4-jo, Atsubetsu-ku Sapporo city, Hokkaido, 004-0004, Japan
TEL 011-898-2151
Homepage URL
Email kanamori@hpgr.jp

Sponsor
Institute Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital
Institute
Department

Funding Source
Organization FUJIFILM Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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
2018 Year 11 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.pieronline.jp/content/article/0386-3603/46120/1993
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 08 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 16 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 10 Month 10 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033639

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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