UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059806 |
|---|---|
| Receipt number | R000068387 |
| Scientific Title | A measurement study of blood lipid components concentration at the time of test food consumption: a randomized, active-controlled, double-blind, crossover comparison study |
| Date of disclosure of the study information | 2025/11/18 |
| Last modified on | 2025/11/18 09:33:51 |
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Basic information
Public title
A measurement study of blood lipid components concentration at the time of test food consumption
Acronym
A measurement study of blood lipid components concentration at the time of test food consumption
Scientific Title
A measurement study of blood lipid components concentration at the time of test food consumption: a randomized, active-controlled, double-blind, crossover comparison study
Scientific Title:Acronym
A measurement study of blood lipid components concentration at the time of test food consumption
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure blood components of test product consumption.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Incremental Area Under the Curve (IAUC) of lipid components
Key secondary outcomes
1. AUC, Cmax and the measured values at each measurement point of lipid components
2. Tmax, T1/2 and the changes from measurements before test product consumption of lipid components
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
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
<Duration>
Single ingestion
<Test products>
Test 1: Food 1
Test 2: Food 2
*Test 1 followed by Test 2.
*The washout period is at least one week.
Interventions/Control_2
<Duration>
Single ingestion
<Test products>
Test 1: Food 2
Test 2: Food 1
*Test 1 followed by Test 2.
*The washout period is at least one week.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who are taking or using medicines (including herbal medicines) or supplements
6. Individuals with allergies (related to pharmaceuticals, test products, or food), particularly with allergies to gelatin, wheat, soybeans, chicken, sesame, pork, or apples
7. Individuals who are pregnant, lactating, or planning to become pregnant during this study
8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
9. Individuals who are judged as ineligible to participate in this study by the physician
10. Individuals who cannot regularly take three meals (breakfast, lunch, and dinner) a day
11. Individuals who take dairy products such as milk and cheese at least four times a week
12. Individuals who are restricting their diet or exercising for the purpose of dieting
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Raffinee International Inc.
Institute
Department
Personal name
Funding Source
Organization
Raffinee International Inc.
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 ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Auxiliary analysis (Including sensitivity analysis)>
As a supplementary analysis, a logarithmic transformation was applied to the primary outcome and the secondary outcome "1", and an analysis based on the equivalence framework was conducted. The analysis model was the same as that used in the main analysis. The estimated differences between groups for the fixed effect "food" and their 90% confidence intervals were calculated, and these were exponentiated to obtain the geometric mean ratios and their 90% confidence intervals. If the 90% confidence interval of the estimated geometric mean ratio is entirely within the pre-specified equivalence margin of log (0.80) to log (1.25), the two groups are considered statistically equivalent.
Management information
Registered date
| 2025 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068387
