UMIN-CTR Clinical Trial

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
Last 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
1st 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