Unique ID issued by UMIN | UMIN000044907 |
---|---|
Receipt number | R000051289 |
Scientific Title | Effects of consumption of the test food on bone metabolism: a randomized, double-blind, placebo-controlled trial |
Date of disclosure of the study information | 2021/07/19 |
Last modified on | 2024/04/04 08:57:13 |
Effects of consumption of the test food on bone metabolism
Effects of consumption of the test food on bone metabolism
Effects of consumption of the test food on bone metabolism: a randomized, double-blind, placebo-controlled trial
Effects of consumption of the test food on bone metabolism
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on bone metabolism
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. The measured values of bone specific alkaline phosphatase (BAP) at 12 weeks after consumption (12w)
1. The amount and rate of change of BAP between screening (before consumption; Scr) and 12w
2. The measured values of BAP at 24 weeks after consumption (24w)
3. The amount and rate of change of BAP between Scr and 24w
4. The measured values of the following items at 12w and 24w: left femoral neck and total amount of lumbar vertebra {bone area, bone mineral density, bone density, T-score, Young Adult Mean (YAM) score, and Z score} measured by Dual Energy X-ray Absorptiometry (DEXA), Flow Mediated Dilation (FMD), maximum expansion width of vessel, diameter of vessels at rest, crosslinked N-telopeptide of type I collagen (NTx), Tartrate-resistant Acid Phosphatase 5b (TRACP-5b), and osteocalcin (OC)
5. The amount and rate of change from Scr in each of the following items at 12w and 24w: left femoral neck and total amount of lumbar vertebra (bone area, bone mineral density, bone density, T-score, YAM score, and Z score) measured by DEXA, FMD, maximum expansion width of vessel, diameter of vessels at rest, NTx, TRACP-5b, and OC
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
2
Treatment
Food |
Duration: 24 weeks
Test food: S・ONE・S
Administration: Take 10 g (two spoonfuls of the attached spoon) twice a day.
* Add two level spoonful of test food and approximately 150 cc of water or your favorite beverage into a prepared shaker. And then shake well to mix and take them.
* Daily dose should be taken within the day.
Duration: 24 weeks
Test food: dextrin
Administration: Take 10 g (two spoonfuls of the attached spoon) twice a day.
* Add two level spoonful of test food and approximately 150 cc of water or your favorite beverage into a prepared shaker, then shake well to mix and take them.
* Daily dose should be taken within the day.
Not applicable |
Not applicable |
Female
1. Japanese
2. Women
3. Healthy subjects
4. Subjects who are natural menopause for at least one year
5. Subjects who are judged as eligible to participate in the study by the physician
6. Subjects who have lower BAP values at Scr
7. Subjects who have 70% or more YAM values in total amount of lumbar vertebra at Scr
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who receive hormonal therapy
5. Subjects who use or take "Foods for Specified Health Uses," "Foods with Function Claims," or other functional food/beverage in daily use
6. Subjects who are currently taking medications (including herbal medicines) and supplements
7. Subjects who are allergic to medications and/or the test-food-related products (particularly gelatin, collagen, and egg)
8. 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
9. Subjects who are smokers
10. Subjects who are judged as ineligible to participate in the study by the physician
20
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
PS Co., Ltd
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
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)
2021 | Year | 07 | Month | 19 | Day |
Unpublished
22
Completed
2021 | Year | 07 | Month | 14 | Day |
2021 | Year | 07 | Month | 14 | Day |
2021 | Year | 07 | Month | 20 | Day |
2022 | Year | 03 | Month | 19 | Day |
2021 | Year | 07 | Month | 19 | Day |
2024 | Year | 04 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051289
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |