UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046570 |
|---|---|
| Receipt number | R000053130 |
| Scientific Title | Effects of consumption of the test food on bone density in healthy Japanese menopause women: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2023/09/30 |
| Last modified on | 2023/06/21 11:34:19 |
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Basic information
Public title
Effects of consumption of the test food on bone density in healthy Japanese menopause women
Acronym
Effects of consumption of the test food on bone density in healthy Japanese menopause women
Scientific Title
Effects of consumption of the test food on bone density in healthy Japanese menopause women: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on bone density in healthy Japanese menopause women
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
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 in healthy Japanese menopause women
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 values of bone density of total amount of lumbar vertebra at 24 weeks after the consumption (24w)
Key secondary outcomes
1. The measured values of bone density of total amount of lumbar vertebra at 12 weeks after the consumption (12w)
2. The measured values of each item of total amount of lumbar vertebra {bone area, bone mineral density, T-score, Young Adult Mean (YAM) score, and Z score} at 12w and 24w
3. The amount of change of each item of total amount of lumbar vertebra (bone area, bone mineral density, bone density, T-score, YAM score, and Z score) from screening (before consumption; Scr) at 12w, and 24w
4. The measured values and amount of change from Scr in each of the following items at 12w, and 24w: each item of lumbar vertebra (L2, L3, L4) (bone area, bone mineral density, bone density, T-score, YAM score, and Z score), left femur (neck, trochanter,and total amount) (bone area, bone mineral density, bone density, T-score, YAM score, and Z score), blood test {osteocalcin (OC), bone-specific alkaline phosphatase (BAP), total type I procollagen-N-propeptide (total P1NP), cross-linked N-telopeptide of type I collagen (NTx), cross-linked C-telopeptide of type I collagen (CTx), and tartrate-resistant acid phosphatase 5b (TRACP-5b)}, and urinalysis {deoxypyridinoline (DPD) and pentosidine}
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 24 weeks
Test food: Active food 1
Administration: Take one pack with water after breakfast
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
Duration: 24 weeks
Test food: Active food 2
Administration: Take one pack with water after breakfast
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_3
Duration: 24 weeks
Test food: Placebo food
Administration: Take one pack with water after breakfast
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
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
Female
Key inclusion criteria
1. Japanese
2. Subjects aged 20 or more and less than 65
3. Female
4. Healthy
5. Subjects who have not had menses for more than one year and are considered to be menopause
6. Subjects who are judged as eligible to participate in the study by the physician
7. Subjects who have 70% or more YAM values in total amount of lumbar vertebra at Scr
Key exclusion criteria
1. Subjects who are osteoporosis (YAM score of total amount of lumbar vertebra is less than 70%)
2. Subjects who have taken medications for osteoporosis
3. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
4. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
5. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
6. Subjects who receive hormonal therapy
7. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use
8. Subjects who take supplements, "Foods for Specified Health Uses", "Foods with Functional Claims", or "Food with Nutrient Function Claims" which may influence bone metabolism such as calcium, vitamin D or K, magnesium, lactic acid bacteria, or isoflavones (including daidzein, genistein, or equol) in daily use
9. Subjects currently taking medicines (include herbal medicines) and supplements
10. Subjects who are allergic to medications and/or the test-food-related products
11. Subjects who suffer from COVID-19
12. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
13. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
30
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
San-Ei Gen F. F. I., Inc.
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 Building, 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
| 2023 | Year | 09 | 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
36
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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 07 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053130
