UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056870 |
|---|---|
| Receipt number | R000064997 |
| Scientific Title | Effects of consumption of the test food on bone mineral density: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/01/30 |
| Last modified on | 2025/05/02 12:48:49 |
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Basic information
Public title
Effects of consumption of the test food on bone mineral density: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of consumption of the test food on bone mineral density: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of consumption of the test food on bone mineral density: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on bone mineral 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 mineral density.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of bone mineral density of frontal lumbar spine (total amount) at 48 weeks after intervention (48w)
Key secondary outcomes
1. The changes and percentage changes from screening (before intervention; Scr) of bone mineral density of frontal lumbar spine (total amount) at 48w
2. The measured values of each item (bone area, bone mineral content, T-score, young adult mean (YAM), and Z-score) of frontal lumbar spine (total amount), and the changes and percentage changes from Scr of them at 48w
3. The measured values of each item (bone area, bone mineral content, bone mineral density, T-score, YAM, and Z-score) of frontal lumbar spine (L1, L2, L3, and L4), and the changes and percentage changes from Scr of them at 48w
4. The measured values of each item (bone area, bone mineral content, bone mineral density, T-score, YAM, and Z-score) of left femur (neck, trochanter, intertrochanteric crest, and total amount), and the changes and percentage changes from Scr of them at 48w
5. The measured values of bone-specific alkaline phosphatase (BAP), total type 1 procollagen N-terminal propeptide (P1NP), and tartrate-resistant acid phosphatase 5b (TRACP-5b)), and the changes and percentage changes from Scr of them, and the logarithmic values of them at 12 weeks after intervention
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 48 weeks
Test food: Collagen peptide
Administration: Take one packet (3.5 g) per day with water, tea, or coffee. It may also be dissolved in them before consumption.
*If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: 48 weeks
Test food: Maltodextrin
Administration: Take one packet (3.5 g) per day with water, tea, or coffee. It may also be dissolved in them before consumption.
*If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next 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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Japanese
2. Women
3. Individuals aged 50 or more
4. Healthy individuals
5. Individuals whose last menstruation occurred one year or more but less than five years ago
6. Individuals whose YAM of frontal lumbar spine (total amount) is more than 70% but less than 80%, and YAM of the femur (total amount) is more than 70%
Key exclusion criteria
Individuals (who/whose)
1. have osteoporosis
2. have taken medications for osteoporosis
3. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
4. have a pacemaker or an implantable cardioverter defibrillator (ICD)
5. 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
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. eating habits are extremely irregular or lifestyles are irregular due to shift work, night work, or others
10. living environment (such as family or work) may majorly change (such as relocation, job transfer, or long-term travel), or whose eating habits or exercise habits may majorly change during this study
11. are taking "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims" (those who take anything that affects bone metabolism (particularly calcium, vitamin D or K, magnesium, or isoflavones (including daidzein, genistein, or equol))
12. are taking medications (including herbal medicines) or supplements
13. are allergic to medicines or foods related to the test product
14. 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
15. are judged as ineligible to participate in this study by the physician
Target sample size
40
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
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
JELLICE Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
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 | 01 | Month | 30 | 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
48
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064997
