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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031489
Receipt No. 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

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035947

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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