UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063179 |
|---|---|
| Receipt number | R000072218 |
| Scientific Title | A crossover study of lipid absorption after a single intake of a test food |
| Date of disclosure of the study information | 2026/10/07 |
| Last modified on | 2026/10/05 17:08:41 |
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Basic information
Public title
Evaluation of lipid absorption after intake of a test food
Acronym
Evaluation of lipid absorption after intake of a test food
Scientific Title
A crossover study of lipid absorption after a single intake of a test food
Scientific Title:Acronym
A crossover study of lipid absorption after a single intake of a test food
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of test food intake on blood lipid-related parameters and the safety of a single intake of the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Triglyceride concentration in chylomicrons
Key secondary outcomes
Efficacy assessment
1) Triglyceride concentrations in lipoprotein fractions (VLDL, LDL, and HDL)
2) Cholesterol concentrations in lipoprotein fractions (chylomicrons, VLDL, LDL, and HDL)
3) Particle numbers in lipoprotein fractions (chylomicrons, VLDL, LDL, and HDL)
4) Blood triglyceride concentration
5) Blood glucose concentration
6) Blood insulin concentration
7) Remnant-like particle cholesterol (RLP-C) concentration
Safety assessment
1) Doctor's questions /Assessment of adverse events
2) Hematological tests
3) Blood biochemical tests
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of pilaf containing 40 g of the test food with clear soup - one-week washout period - single intake of pilaf containing 40 g of the control food with clear soup.
Interventions/Control_2
Single intake of pilaf containing 40 g of the control food with clear soup - one-week washout period - single intake of pilaf containing 40 g of the test food with clear soup.
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Healthy Japanese male subjects aged 20 to 39 years.
2. Subjects with a BMI of 18.5 kg/m2 or higher and less than 25.0 kg/m2.
3. Subjects who have received a sufficient explanation of the purpose and details of the study, have understood the study, and have voluntarily agreed to participate in the study by providing written informed consent.
Key exclusion criteria
1. Subjects with a current or past history of lipid or glucose metabolism disorders, thyroid, liver, biliary, kidney or pancreatic disease, malabsorption, or other diseases affecting lipid metabolism.
2. Subjects unable to stop using drugs, quasi-drugs, health foods, foods for specified health uses, foods with function claims, supplements, or probiotic drinks that may affect lipid/glucose metabolism, digestion, absorption, or gastrointestinal function.
3. Subjects with excessive alcohol intake: average daily alcohol intake >=20 g, or intake >=60 g on one occasion at least four times during the past 4 weeks.
4. Smokers or regular users of heated tobacco, e-cigarettes, or other nicotine products.
5. Subjects who regularly perform strenuous exercise, including competitive sports or gym exercise several times a week.
6. Subjects unable to fast for at least 12 h before a study visit.
7. Subjects unable to avoid alcohol and strenuous exercise for 48 h before a study visit.
8. Subjects unable to avoid caffeinated beverages, energy drinks, chewing gum, and supplements on a study visit day.
9. Subjects with food allergy, intolerance, or hypersensitivity.
10. Subjects planning to change their lifestyle or diet during the study.
11. Subjects on a carbohydrate-restricted or weight-loss diet.
12. Subjects who donated or had >200 mL of blood collected within 1 month, or >400 mL within 3 months before screening.
13. Subjects judged unsuitable for the study by the principal investigator or subinvestigator.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yoshida |
Organization
Taiyo Yushi Corp.
Division name
Research & Development Dept.
Zip code
221-0022
Address
2-7, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa
TEL
045-441-4961
Takashi.Yoshida3@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sagawa |
Organization
Inc. M･C Connect
Division name
Representative director
Zip code
371-0016
Address
5-656-17, Jotomachi, Maebashi-shi, Gunma
TEL
027-212-5608
Homepage URL
sagawa@mc-connect.co.jp
Sponsor or person
Institute
Taiyo Yushi Corp.
Institute
Department
Personal name
Funding Source
Organization
Taiyo Yushi Corp.
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2, Moriya-cho, Yokohama-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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
| 2026 | Year | 10 | Month | 07 | 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 | 09 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 06 | 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 | 10 | Month | 05 | Day |
Last modified on
| 2026 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072218
