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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044700
Receipt No. R000051046
Scientific Title Effect of intake of a test food on postprandial blood triglyceride level -a randomized, double blind placebo-controlled, cross-over study-
Date of disclosure of the study information 2021/06/30
Last modified on 2021/06/29

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Basic information
Public title Effect of intake of a test food on postprandial blood triglyceride level -a randomized, double blind placebo-controlled, cross-over study-
Acronym Effects of a test food on postprandial blood triglyceride level
Scientific Title Effect of intake of a test food on postprandial blood triglyceride level -a randomized, double blind placebo-controlled, cross-over study-
Scientific Title:Acronym Effects of a test food on postprandial blood triglyceride level
Region
Japan

Condition
Condition Healthy adult (who has fasting blood triglyceride level less than 150 mg/dl )
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of a test food on postprandial blood triglyceride level after intake of high fat diet
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference of serum triglyceride level at sequential sampling time points and AUC (area under the blood concentration - time curve)
(before ingestion of high fat diet, and 2, 3, 4, 6 hours after ingestion of a high fat)
Key secondary outcomes The difference of serum RLP cholesterol level at sequential sampling time points and AUC

Other lipid metabolism related factors
(Total cholesterol, LDL-cholesterol, HDL-cholesterol, free fatty acid, beta lipoprotein, lipoprotein fraction, phospholipid)
(before ingestion of high fat diet and 2, 3, 4, 6 hours after ingestion of a high fat)

Height, body weight, BMI(before ingestion of high fat diet)

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 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) Healthy subjects aged 20 to 65 years old.
(2) Subjects whose fasting serum triglyceride levels are less than 150 mg/dL.
(3) Subjects giving written informed consent.
Key exclusion criteria a. Subjects who have a history of treatment for malignancy, heart failure and myocardial infarction
b. Subjects who are being treated for the following chronic diseases; atrial fibrillation, arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, other chronic diseases
c c. Frequent users of medicine (includes TCM) and/or supplements and/or health foods that could affect lipid metabolism.
d. Subjects who have allergy (medical products, test food related food)
e. Subjects who are pregnant or breastfeeding or planning to get pregnant during the study
f. Subjects who are judged as unsuitable for the study by the physician in change due to other reason.

Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yamatsu
Middle name
Last name Atsushi
Organization Pharma Foods International Co., Ltd.
Division name R&D department
Zip code 615-8245
Address 1-49 Goryo-Ohara, Nishikyo-ku, Kyoto 615-8245, Japan
TEL 075-748-9829
Email a-yamatsu@pharmafoods.co.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Yamada
Organization Pharma Foods International Co., Ltd.
Division name R&D department
Zip code 615-8245
Address 1-49 Goryo-Ohara, Nishikyo-ku, Kyoto 615-8245, Japan
TEL 075-748-9829
Homepage URL
Email h-yamada@pharmafoods.co.jp

Sponsor
Institute Pharma Foods International Co., Ltd.
Institute
Department

Funding Source
Organization Mitsui Sugar Co., Ltd.
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 the ethics committees of Yoga Allergy Clinic
Address 4-32-16, Yoga, Setagaya-ku, Tokyo, 158-0097, Japan
Tel 03-5491-4478
Email jim@medipharma.co.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

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 30 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
2021 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 30 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 29 Day
Last modified on
2021 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051046

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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