UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063228 |
|---|---|
| Receipt number | R000072369 |
| Scientific Title | A Study on the Effects of Continued Consumption of the Investigational Food on LDL-C and Blood Lipid-Related Metabolism, Including Exploratory Indicators - Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Comparison - |
| Date of disclosure of the study information | 2026/11/13 |
| Last modified on | 2026/10/13 14:42:48 |
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Basic information
Public title
A Study on the Effects of Continued Consumption of the Investigational Food on LDL-C and Blood Lipid-Related Metabolism, Including Exploratory Indicators
Acronym
A Study on the Effects of Continued Consumption of the Investigational Food on LDL-C and Blood Lipid-Related Metabolism, Including Exploratory Indicators
Scientific Title
A Study on the Effects of Continued Consumption of the Investigational Food on LDL-C and Blood Lipid-Related Metabolism, Including Exploratory Indicators
- Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Comparison -
Scientific Title:Acronym
A Study on the Effects of Continued Consumption of the Investigational Food on LDL-C and Blood Lipid-Related Metabolism, Including Exploratory Indicators
- Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Comparison -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the cholesterol-lowering effect, primarily on LDL-C, of 12 weeks of continuous intake of the test food in adults aged 20 to under 75 years with LDL-C levels between 120 and 140 mg/dL. The study also aims to observe changes in blood lipid parameters, lipoprotein-related markers, risk indicators associated with blood lipids, aging markers, and other exploratory endpoints.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Change in LDL-C from baseline after 12 weeks
Key secondary outcomes
- Percent change in LDL-C from baseline at 12 weeks
- Proportion of participants with >=5% reduction in LDL-C from baseline
- Proportion of participants achieving LDL-C <120 mg/dL
- Blood lipid and metabolic markers
- Vascular function and cardiovascular risk-related markers
- Body weight and BMI
- Inflammation-related markers
- Biological age-related markers
- Renal function markers
- Fatigue, sleep, and stress-related measures
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume one bottle (280 mL) of the test food every morning for 12 weeks.
Interventions/Control_2
Consume one bottle (280 mL) of the placebo food every morning for 12 weeks.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: 20 years or older, under 75 years
2. Japanese nationality, male or female
3. BMI >=18.5 kg/m^2 and <30.0 kg/m^2
4. LDL-C >=120 mg/dL and <140 mg/dL
5. Able to enter electronic diaries via smartphone or PC
6. Provided written informed consent after receiving sufficient explanation and understanding the study purpose and procedures
Key exclusion criteria
1. Currently receiving medication for chronic diseases
2. Currently undergoing dietary or exercise therapy under physician supervision
3. History or presence of serious diseases
4. History of gastrointestinal diseases or surgeries affecting digestion/absorption (except appendicitis or colon polyps removed by endoscopy)
5. Currently taking medications, quasi-drugs, health foods, supplements, specified health foods, or foods with functional claims that may affect blood lipids or lipid metabolism
6. Taking other over-the-counter medications, quasi-drugs, health foods, supplements, specified health foods (eligible if discontinued during study)
7. History or presence of food or drug allergies
8. Habitual excessive alcohol consumption (>=40 g pure alcohol/day)
9. Habitual excessive smoking (>=21 cigarettes/day)
10. Shift workers with night shifts
11. Plans to significantly change lifestyle (diet, sleep, exercise) during study period (e.g., long trips)
12. Pregnant, breastfeeding, or planning pregnancy during study period
13. Participating in other clinical trials of drugs or health foods, within 4 weeks after completion, or planning to participate in another trial after consent
14. Deemed unsuitable for the study by the principal or sub-investigator
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Kouhei |
| Middle name | |
| Last name | Goto |
Organization
KADOYA SESAME MILLS INC.
Division name
Head of Technical Research Section Protein Business Development Department Research & Development Division
Zip code
141-0001
Address
Osaki Twin Building East 4F,5-1-18 Kitashinagawa Shinagawa-ku, Tokyo
TEL
03-6721-6957
kouhei.goto@kadoya.com
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
KADOYA SESAME MILLS 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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 | 11 | Month | 13 | 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 | 09 | Month | 29 | Day |
Anticipated trial start date
| 2027 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 09 | 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 | 09 | Day |
Last modified on
| 2026 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072369
