UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062143 |
|---|---|
| Receipt number | R000070847 |
| Scientific Title | A Study to Verify the Additional Weight Loss Effect of Consuming Test Foods in Specific Health Guidance |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/06/16 18:32:16 |
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Basic information
Public title
A Study to Verify the Additional Weight Loss Effect of Consuming Test Foods in Specific Health Guidance
Acronym
A Study to Verify the Additional Weight Loss Effect of Consuming Test Foods in Specific Health Guidance
Scientific Title
A Study to Verify the Additional Weight Loss Effect of Consuming Test Foods in Specific Health Guidance
Scientific Title:Acronym
A Study to Verify the Additional Weight Loss Effect of Consuming Test Foods in Specific Health Guidance
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study targets men who are eligible for active guidance under the Specific Health Guidance program designated by the Ministry of Health, Labour and Welfare. The objective is to verify the additional benefits of consuming the test food within the context of Specific Health Guidance by providing study participants in the test food intake group with information regarding Specific Health Guidance and the test food, and having them replace one of their daily meals (breakfast, lunch, or dinner) with the test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight
Key secondary outcomes
1) Office blood pressure (systolic blood pressure/diastolic blood pressure)
2) Home blood pressure (systolic blood pressure/diastolic blood pressure)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1) Guidance equivalent to specific health guidance
2) Information
3) Oral intake of the test food (replacing one meal-breakfast, lunch, or dinner-with the test food for 12 weeks)
Interventions/Control_2
1) Guidance equivalent to specific health guidance
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
[1] Men aged 40 to 64 at the time of obtaining consent
[2] Individuals who are the subject of the Specific Health Guidance designated by the Ministry of Health Labour and Welfare (a subject of an active support).
(Criteria)
Meet the criterion 1 and at least 2 items from criterion 3, or meet the criterion 2 and at least 3 items from criterion 3.
1) Abdominal circumference: over 85 cm.
2) BMI: over 25 kg/m2.
3)Additional conditions:
- A smoker.
- Blood glucose:
fasting blood glucose: over 100 mg/dl or HbA1c: over 5.6%.
- Lipids:
Triglycerides: over 150 mg/dl or HDL-Cho: less than 40 mg/dl
- Blood pressure:
systolic blood pressure: over 130 mmHg and/or diastolic blood pressure: 85 mmHg.
[3]Individuals whose written informed consent has been obtained.
[4]Individuals who can visit an inspection facility and be inspected in designated days.
[5]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
Individuals
[1] currently suffering from any medical condition and undergoing drug treatment.
[2] with a history of serious disorders or current conditions affecting the digestive system, liver, kidneys, heart, lungs, blood, or mental health.
[3] who have taken medication for the treatment of a medical condition within the past month.
[4] with symptoms of drug or food allergies.
[5] who have donated whole blood or plasma in amounts exceeding 200 mL within the past month or 400 mL within the past three months.
[6] who are currently receiving specific health guidance, or who have received such guidance within the past six months prior to the pre-intervention examination; or individuals who are likely to receive specific health guidance during the study period.
[7] with irregular eating habits and a tendency toward picky eating.
[8] whose daily alcohol consumption exceeds 60 g of pure alcohol per day.
[9] who currently, or within the past three months, regularly consume FOSHU, FFC, or other health foods claimed to improve lipid/glucose metabolism, blood pressure, visceral fat, or body fat; or who plan to consume such products during the study period.
[10] who may change their lifestyle habits during the study period.
[11] who would find it difficult to consume the test food by substituting it for one of their meals (breakfast, lunch, or dinner) during the trial period.
[12] who are unable to properly store or consume the test food due to reasons such as the inability to install a freezer or the lack of a microwave oven.
[13] currently participating in another human clinical trial, or individuals for whom less than three months have elapsed since their participation in another human clinical trial.
[14] who themselves or their families work at companies or research institutions that develop, manufacture, or sell health and functional foods.
[15] judged inappropriate for the study by the principal.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Futoshi |
| Middle name | |
| Last name | Nakamura |
Organization
NISSIN FOODS HOLDINGS CO., LTD.
Division name
Future Food Research & Development Division
Zip code
192-0001
Address
2100 Tobukimachi, Hachioji-shi, Tokyo
TEL
+81-42-696-7606
futoshi.nakamura@nissin.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
NISSIN FOOD PRODUCTS CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOOD PRODUCTS 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 | 07 | Month | 06 | 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 | 06 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 22 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070847
