UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059933 |
|---|---|
| Receipt number | R000068544 |
| Scientific Title | Effects of consumption of the test food on bone density: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/12/01 14:20:20 |
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Basic information
Public title
Effects of consumption of the test food on bone density
Acronym
Effects of consumption of the test food on bone density
Scientific Title
Effects of consumption of the test food on bone density: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on bone density
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on bone density.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary bone density measurement
Key secondary outcomes
Secondary bone density measurements, urinalysis, peripheral blood tests, physical measurements, and adverse events
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 24 weeks
Test product: Test food
Administration: Three capsules/pack/day
Interventions/Control_2
Duration: 24 weeks
Test product: Placebo food
Administration: Three capsules/pack/day
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
Female
Key inclusion criteria
1. Japanese
2. Women
3. Adults
4. Healthy participants
5. Participants who are menopause for at least one year
6. Participants who have 70% or more young adult mean (YAM) values bone density of lumbar vertebra (total amount)
Key exclusion criteria
Participants who
1. have osteoporosis
2. have taken medicines for osteoporosis
3. are undergoing treatment or have a history of malignant tumor, heart failure, or myocardial infarction
4. have a pacemaker or an implantable cardioverter defibrillator
5. are 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
6. receive hormonal therapy
7. are heavy smokers (generally smoking 21 or more cigarettes per day)
8. consume excessive alcohol {generally drinking 60 g or more of pure alcohol per day (3 go of sake, 3 medium bottles of beer (1,500 mL), 2 go of shochu, or about 5 glasses of wine (about 600 mL) at least 6 days per week}
9. have extremely irregular eating habits or irregular life rhythms due to shift work, late-night work, or other factors
10. may experience significant changes (e.g., relocation, job transfer, or long-term travel) in their living environment (e.g., family or work) or in their eating and exercise habits during this study
11. are taking Foods for Specified Health Uses, Foods with Functional Claims, or Food with Nutrient Function Claims (particularly those containing calcium, vitamin D or K, magnesium, isoflavones including daidzein, genistein, or equol, lactic acid bacteria other than test food, or others which affect bone metabolism)
12. are taking or using medicines (including herbal medicines) or supplements
13. are allergic to medicines or foods related to the test product
14. are taking antithrombotic drugs such as warfarin
15. are pregnant, lactating, or planning to become pregnant during this study
16. 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
17. are judged as ineligible to participate in this study by the physician
Target sample size
100
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
Euglena Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Euglena 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
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 | 12 | Month | 01 | 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 | 26 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Statistical analysis details>
Subgroups will be defined based on the factors in the following variables.
Age at screening: >= / < median
Body height at screening: >= / < median
Body weight at screening: >= / < median
BMI at screening: >= / < median
BMI at screening: >= / < 25 kg/m2
Exercise habit: Yes / No
Urinalysis: >= / < median
Peripheral blood tests: >= / < median
Daily calcium intake: >= / < median
Daily calcium intake: >= / < the recommended intake for calcium in the Japanese Dietary Reference Intakes (2025 Edition)
Daily vitamin D intake: >= / < median
Daily vitamin D intake: >= / < the adequate intake for vitamin D in the Japanese Dietary Reference Intakes (2025 Edition)
Steps: >= / < median
Steps: >= / < the daily step count target in Health Japan 21 (Third Phase)
Years since menopause: >= / < 5 years
Bone density: >= / < median
YAM score: 70%-79% / >= 80%
Management information
Registered date
| 2025 | Year | 12 | Month | 01 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068544
