UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031489 |
|---|---|
| Receipt number | R000035947 |
| Scientific Title | A verification study of improvements in bone density: a randomized double-blind placebo-controlled study |
| Date of disclosure of the study information | 2018/02/26 |
| Last modified on | 2019/05/31 09:58:24 |
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Basic information
Public title
A verification study of improvements in bone density: a randomized double-blind placebo-controlled study
Acronym
A verification study of improvements in bone density
Scientific Title
A verification study of improvements in bone density: a randomized double-blind placebo-controlled study
Scientific Title:Acronym
A verification study of improvements in bone density
Region
| Japan |
Condition
Condition
Healthy Japanese adult people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of improvements in bone density with intake of the test food
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bone density of total amount of lumbar vertebra
* Measured by Dual Energy X-ray Absorptiometry (DEXA)
* Perform the test at screening and examination before consuming and at 12 and 24 weeks after ingestion
Key secondary outcomes
1. Left femur (thigh bone) (neck, trochanter, inter, total amount, and Ward' s): Bone area, bone mineral density, bone density, T-score, YAM score, and Z score
2. Lumbar vertebra (L2, L3, L4, and total amount): Bone area, bone mineral density, T-score, YAM score, and Z score
3. Peripheral blood test
Tartrate-resistant Acid Phosphatase 5b (TRACP-5b), osteocalcin (OC), bone specific alkaline phosphatase (BAP), crosslinked N-telopeptide of type I collagen (NTx)
4. Urinalysis
Crosslinked N-telopeptide of type I collagen (NTx), deoxypyridinoline (DPD)
5. Subjective symptoms
Questionnaire of physical and life related to osteoporosis
*1,2 Measured by Dual Energy X-ray Absorptiometry (DEXA)
*1-5 Perform the tests at screening and examination before consuming and at 12 and 24 weeks after ingestion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 24 weeks
Test materials: Corn syrup containing maltobionic acid
Dose: 7 g/day
Administration: Take it during or after meal with water, carbonated water, milk, or apple juice, even with salad, fruits, yogurt, or etc.
* 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 materials: maltose syrup
Dose: 7 g/day
Administration: Take it with or after meal with water, carbonated water, milk, or apple juice, or even with salad, fruits, yogurt, or etc.
* If you forget to take the test food, take it as soon as you remember within the 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
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Japanese adult female
2. Subjects who are menopause (natural menopause) for at least 1 year
3. Subjects who are judged as eligible to participate in the study by the physician
4. Subjects who have 70% or more but less than 100% in total amount of lumbar vertebra (the mean in young adults) of YAM score at screening and examination before consuming. If number of subjects who passed the inclusion criteria is below the sample size, select them whose YAM scores are closer to 100%
Key exclusion criteria
1. A medical history of malignant tumor, heart failure or myocardial infarction
2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
3. Subjects who take supplements, "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims" related to bone metabolism, such as calcium, vitamin D, vitamin K, magnesium, isoflavones, (included daidzein, genistein, equol, or etc.), more than once a week
4. Currently taking medications (include herbal medicines), "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage
5. Subjects who are allergic to medicines and/or the test food related products
6. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
7. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Kazuo
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 Sucrochemical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara 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
info@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)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 26 | 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
38
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
| 2018 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 26 | Day |
Last modified on
| 2019 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035947
