UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055931 |
|---|---|
| Receipt number | R000063912 |
| Scientific Title | Effects of consumption of the food containing lactic acid bacteria on bone density: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/10/24 |
| Last modified on | 2025/01/09 08:59:06 |
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Basic information
Public title
Effects of consumption of the food containing lactic acid bacteria on bone density: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of consumption of the food containing lactic acid bacteria on bone density: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of consumption of the food containing lactic acid bacteria on bone density: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the food containing lactic acid bacteria on bone 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 food containing lactic acid bacteria on bone density
Basic objectives2
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 density of total amount of frontal lumbar vertebra at 53 weeks after consumption (53w)
Key secondary outcomes
1. The measured value of bone density of total amount of frontal lumbar vertebra at 27 weeks after consumption (27w)
2. The amount and percentage of change of bone density of total amount of frontal lumbar vertebra from screening (before consumption; Scr) to 27w and 53w
3. The measured values of each item (bone area, bone mineral content, T-score, young adult mean (YAM) score, Z score) of total amount of frontal lumbar vertebra at 27w and 53w, and the amount and percentage of changes of them from Scr
4. The measured values of each item (bone area, bone mineral content, bone density, T-score, YAM score, Z score) of frontal lumbar vertebra (L2, L3, L4) at 27w and 53w, and the amount and percentage of changes of them from Scr
5. The measured values of each item (bone area, bone mineral content, bone density, T-score, YAM score, Z score) of left femur (neck, trochanter, inter, total amount) at 27w and 53w, and the amount and percentage of changes of them from Scr
6. The measured values of simplified menopausal index (SMI) score, grip strength, acetic acid, propionic acid, iso-butyric acid, n-butyric acid, iso-valeric acid, n-valeric acid, lactic acid, succinic acid, formic acid, body weight, body mass index (BMI), body fat percentage, lean body mass, and appendicular skeletal muscle mass at 27w and 53w
7. The measured values of cross-linked N-telopeptide of type I collagen (NTx), osteocalcin (OC), bone-specific alkaline phosphatase (BAP), total type I procollagen-N-propeptide (total P1NP), and tartrate-resistant acid phosphatase 5b (TRACP-5b) corrected for urea-creatinine at 27w and 53w, and the amount and percentage of changes of them from Scr
8. Individuals whose responses to an original questionnaire improved by one or more scales at 27w and 53w compared to Scr
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
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 53 weeks
Test food: Food containing lactic acid bacteria
Administration: Take one tablet once a day
Interventions/Control_2
Duration: 53 weeks
Test food: Food not containing lactic acid bacteria
Administration: Take one tablet once a 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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1. Japanese
2. Individuals aged 40 or more and less than 70
3. Women
4. Healthy individuals
5. Individuals who have not had date of menstrual onset for at least one year
6. Individuals whose YAM score of bone density in total amount of frontal lumbar vertebra and femur are 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 cigarettes or more per day)
8. regularly drink alcohol {generally drinking 60 g/day as absolute alcohol (about 3 go of sake, 3 medium bottles (1,500 mL) of beer, 2 go of shochu, just under 5 glasses (600 mL) of wine) at least six days a week}
9. have extremely irregular eating habits or irregular lifestyles by shift work, night work, or other reasons
10. living environment (e.g., family, or work) may major changes (e.g., relocation, work transfer, or long-term travel), or eating or exercise habits may major changes during this study
11. take "Foods for Specified Health Uses", "Foods with Functional Claims", or "Food with Nutrient Function Claims" (particularly those containing calcium, vitamin D or K, magnesium, isoflavones (including daidzein, genistein, or equol), lactic acid bacteria other than test food, or others which affect bone metabolism)
12. are taking or using medications (including herbal medicines) and supplements
13. are allergic to medicines and 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
88
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
HOUSE WELLNESS FOODS CORPORATION
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
| 2024 | Year | 10 | Month | 24 | 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
96
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
| 2024 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Statistical Analysis Details>
Subgroup analysis will be performed for the following two populations. All subgroups will be constructed based on full analysis set (FAS) or per protocol set (PPS).
a. The population with YAM score for the smaller of "bone density of total amount of frontal lumbar vertebra" and "bone density of total amount of left femur" determined to be bone loss (more than -2.5 SD and less than -1.0 SD) at Scr (SS1)
b. The population with SMI score is less than 51 at Scr (SS2)
Management information
Registered date
| 2024 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063912
