UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060571 |
|---|---|
| Receipt number | R000069282 |
| Scientific Title | A study to evaluate the postprandial increase in blood triglyceride levels after consumption of a single serving of processed food product. |
| Date of disclosure of the study information | 2026/02/03 |
| Last modified on | 2026/02/03 20:14:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to evaluate the postprandial increase in blood triglyceride levels after consumption of a single serving of processed food product.
Acronym
A study to evaluate the postprandial increase in blood triglyceride levels after consumption of a single serving of processed food product.
Scientific Title
A study to evaluate the postprandial increase in blood triglyceride levels after consumption of a single serving of processed food product.
Scientific Title:Acronym
A study to evaluate the postprandial increase in blood triglyceride levels after consumption of a single serving of processed food product.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of single serving of processed food product on postprandial blood triglyceride levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood triglyceride level of Area under the curve (AUC) after single serving of the test food
Key secondary outcomes
Fasting triglyceride levels and postprandial, RLP cholesterol blood free fatty acids, blood glucose levels, insulin levels, and a questionnaire regarding satiety after single serving of the test food
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food1 (single serving) - washout period - test food2 (single serving) - washout period - test food3 (single serving)
Interventions/Control_2
Intake of test food2 (single serving) - washout period - test food3 (single serving) - washout period - test food1 (single serving)
Interventions/Control_3
Intake of test food3 (single serving) - washout period - test food1 (single serving) - washout period - test food2 (single serving)
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Healthy males from 20 to 59 years of age
(2) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study
Key exclusion criteria
(1) Subjects who regularly use health foods that may affect the research.
(2) Subjects who regularly use pharmaceutical drugs or quasi-drugs and cannot restrict their intake during the research period.
(3) Subjects who have shown abnormalities in clinical test values or cardiopulmonary function, or have a medical history or surgical history that may affect the study are deemed unsuitable for participation in the study.
(4) Subjects who may be at risk of developing allergies in relation to the research.
(5) Subjects who require regular medication (whether topical or oral), those currently undergoing treatment for a disease (excluding dry eye or dental caries treatment), and those with a history of severe diseases that required medication treatment.
(6) Subjects who work in shifts, night shifts, or have irregular daily schedules.
(7) Heavy drinkers.
(8) Smoker.
(9) Subjects with lactose intolerance
(10) Subjects with BMI less than 18.5 or greater than 30.0 kg / m^2
(11) Subjects with fasting blood triglyceride levels greater than 150 mg/dL.
(12) Subjects with fasting low-density lipoprotein cholesterol levels greater than 140 mg/dL.
(13) Subjects with fasting blood glucose levels less than 70 or greater than 110 mg/dL.
(14) Subjects with fasting HbA1c(NGSP) greater than 5.6%.
(15) Subjects who have participated in other clinical studies, clinical trials, or human trials from within one month before the date of consent.
(16) Subjects expected to experience significant changes in their living environment during the research period.
(17) Subjects whose blood donation volume before the start of the study exceeds the regulations.
(18) Subjects who regularly skip meals or have extremely irregular eating habits.
(19) Subjects deemed inappropriate as subjects by the responsible investigator due to background information, pre-examination results, or other reasons.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Matsuura |
Organization
NISSIN FOODS HOLDINGS CO., LTD.
Division name
Health Science Research Division
Zip code
192-0001
Address
2100 Tobukimachi, Hachioji-shi, Tokyo
TEL
070-6640-1647
masanori.matsuura@nissin.com
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Yasui |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo,
TEL
080-7710-1158
Homepage URL
yasui.kei475@eps.co.jp
Sponsor or person
Institute
NISSIN FOODS HOLDINGS CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOODS HOLDINGS 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.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
医療法人社団快晴会 田奈整形外科・外科（神奈川県）、医療法人社団快晴会 北新横浜整形外科・外科（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 03 | 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
| 2026 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069282
