UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061875 |
|---|---|
| Receipt number | R000070442 |
| Scientific Title | Evaluation of the Effects of a Test Food on Lipid-Related Parameters --A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial-- |
| Date of disclosure of the study information | 2026/06/11 |
| Last modified on | 2026/05/14 17:12:31 |
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Basic information
Public title
Evaluation of the Effects of a Test Food on Lipid-Related Parameters
--A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial--
Acronym
Evaluation of the Effects of a Test Food on Lipid-Related Parameters
Scientific Title
Evaluation of the Effects of a Test Food on Lipid-Related Parameters
--A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial--
Scientific Title:Acronym
Evaluation of the Effects of a Test Food on Lipid-Related Parameters
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 on lipid-related parameters and the safety of continuous consumption of the test food over a 12-week period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
low-density lipoprotein cholesterol
Key secondary outcomes
* Secondary outcome measures
1) Lipid-related indicators
2) Body Composition Measurement
3) Waist and Hip Circumference Measurement / Waist-to-Hip Ratio
* Safety Assessment Items
1) Blood pressure/pulse measurement
2) Hematological tests
3) Blood chemistry tests
4) Urinalysis
5) Doctor's questions /Assessment of adverse events and side effects
6) Daily activity log
7) Dietary Habits Survey
* Exploratory indicators
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (1 packet in a day; 12 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 packet in a day; 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women between 20 and 65 years of age at the time of obtaining consent to participate in the study.
2) Individuals with LDL cholesterol in the borderline (120 mg/dL to 139 mg/dL) or mild range (140 to 159 mg/dL).
3) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
4) Individuals who can come to the designated venue for this study and be inspected.
Key exclusion criteria
Individuals
1) with chronic diseases and individuals undergoing treatment for any disease.
2) with a history or current medical history of chronic fatigue syndrome, psychiatric disorders, sleep disorders, hypertension, diabetes, dyslipidemia, or other serious diseases.
3) with a history or current medical history of serious diseases of the liver, kidney, heart, lung, blood, digestive tract, etc.
4) with serious anemia.
5) who have a habit of taking or applying medication for the purpose of disease treatment in the past month.
6) whose BMI is over 30 kg/m2.
7) who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug.
8) who are currently, or have been within the past 3 months, habitually consuming or will consume during the study period foods, foods for specified health uses, foods with functional claims, health foods, supplements, etc. that contain a large amount of ingredients similar to those in the test foods.
9) with irregular eating habits and a strong tendency toward picky eating.
10) whose daily alcohol consumption exceeds 40 g/day for men and 20 g/day for women on a weekly average of pure alcohol equivalent.
11) who are a smoker.
12) who work in shifts, work at night, or otherwise have irregular lifestyles.
13) with possible changes of life style during the test period (e.g., work at night, travel for long periods of time, etc.).
14) who have donated 200 mL of whole blood or 400 mL or more of whole blood or blood components within one month prior to the start of the examination, or within three months prior to the start of the examination.
15) who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial.
16) who are pregnant, lactating or can become pregnant and intend to become pregnant during the study period.
17) judged inappropriate for the study by the principal.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Watanabe |
Organization
MEGMILK SNOW BRAND Co., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2, Minamidai, Kawagoe-shi, Saitama, 350-1165, Japan
TEL
+81-49-242-8165
masayuki-watanabe@meg-snow.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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 | 06 | Month | 11 | 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 | 05 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 23 | 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 | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070442
