UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037160 |
|---|---|
| Receipt number | R000042302 |
| Scientific Title | Effects 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 | 2019/07/02 |
| Last modified on | 2022/06/30 13:36:23 |
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Basic information
Public title
Effects 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
Effects 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 differences of serum triglyceride level at sequential sampling time point and AUC (area under the blood concentration - time curve)
Key secondary outcomes
The change of serum RLP cholesterol level at sequential sampling time point and AUC
Other lipid metabolism related factors (total cholesterol, LDL-cholesterol, HDL-cholesterol, free fatty acid, lipoprotein (a,b), lipoprotein fraction (HDL, LDL, VLDL), phospholipid)
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 (more than 6 days) - single ingestion of the test food
Interventions/Control_2
Single ingestion of the placebo food - washout period (more than 6 days) - single ingestion of the test 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 64 years old.
(2) Subjects whose fasting serum triglyceride levels are less than 150 mg/dL in medical check up within 1 year
(3) Subjects who gave written informed consent.
Key exclusion criteria
a. Subjects who have a history of treatment for malignancy, heart failure and myocardial infarction
b. Subjects who have been treated for the following chronic diseases: atrial fibrillation, arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, etc.
c. Subjects who frequently use oral medication and/or supplements and/or functional foods (include traditional Chinese medicine) could affect lipid metabolism.
d. Subjects who have allergy (medical products, test food related food)
e. Subjects who are planned to get pregnant after informed consent for the current study or are pregnant or breastfeeding.
f. Subjects who are judged as unsuitable for the study by the physician in charge for other reason.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamatsu |
Organization
Pharma Foods International Co., Ltd.
Division name
R&D department
Zip code
615-8245
Address
1-49, Goryo-Ohara, Nishikyo-ku, Kyoto, Japan
TEL
0753948605
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, Japan
TEL
0753948605
Homepage URL
h-yamada@pharmafoods.co.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committees of Nihonbashi Egawa Clinic
Address
Kotobuki Building.2F, 1-1-3, Yaesu, Chuo-ku, Tokyo, Japan)
Tel
03-5204-0311
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
| 2019 | Year | 07 | Month | 02 | 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
30
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
delay of data analysis
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
| 2019 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 25 | Day |
Last modified on
| 2022 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042302
