Unique ID issued by UMIN | UMIN000048433 |
---|---|
Receipt number | R000055186 |
Scientific Title | Effects of lactic acid bacteria intake on bone metabolism markers in postmenopausal women: an exploratory study |
Date of disclosure of the study information | 2022/08/09 |
Last modified on | 2023/07/23 12:46:22 |
Effects of lactic acid bacteria intake on bone metabolism markers in postmenopausal women: an exploratory study
Effects of lactic acid bacteria on bone metabolism markers: an exploratory study
Effects of lactic acid bacteria intake on bone metabolism markers in postmenopausal women: an exploratory study
Effects of lactic acid bacteria on bone metabolism markers: an exploratory study
Japan |
N/A
Not applicable | Adult |
Others
NO
To investigate the effects of lactic acid bacteria intake on bone metabolism markers in postmenopausal women: an exploratory study.
Efficacy
Exploratory
Not applicable
Bone resorption markers
Bone formation markers, cartilage degradation markers, urinary amino acids(a marker of muscle protein breakdown, etc.), serum cytokines, biomarker of intestinal barrier function, microbiome, JKOM, grip strength, body composition, bone mass (Quantitative ultrasound (QUS) of the calcaneus), self-assessment table for calcium intake, VDDQ-J, and simple vitamin K intake questionnaire
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
12-week intake of active food (high dose)
12-week intake of active food (low dose)
12-week intake of placebo food
50 | years-old | <= |
Not applicable |
Female
1. Women aged over 50 years old and who are from 1 year to 10 year after menopause when consent acquisition
2. Subjects with a BMI of 18.5 or more and less than 30.
3. Subjects giving informed consent
1.Subjects with food allergies
2.Subjects with lactose intolerance
3.Subjects who have menopause before 43 years old
4.Subjects who have been diagnosed with osteoporosis
5.Subjects who have undergone bilateral oophorectomy
6.Subjects who suffer from serious disorders of liver, kidney, heart, lung, or digestive organs (including gastric resection), diabetes, rheumatoid arthritis, neurological/mental diseases, endocrine diseases, or other serious and/or progressive diseases.
7.Subjects who have been diagnosed with congenital bone metabolism diseases (osteogenesis imperfecta, Marfan syndrome, etc.)
8.Subjects who have a history of bone fracture within the past year
9.Subjects who have been receiving long-term medical treatment (hospitalization, etc.) within the past year.
10.Subjects currently receiving medicine treatment known to affect bone metabolism (hormone therapy, steroids (last 6 months), warfarin, SSRI, anticonvulsants, methotrexate, heparin, beta-blockers, alpha-blockers, alpha, beta-blockers, etc.)
11.Heavy drinkers (weekly average of 30 g/day or more of pure alcohol)
12.Smoker
13.Subjects who regularly use medicines, health foods or supplements that may affect this study (e.g. intestinal regulators, calcium, magnesium, vitamin D, vitamin K, soy isoflavone, foods/beverages/supplements containing lactic acid bacteria (e.g. yogurt), foods/beverages/supplements containing prebiotics such as oligosaccharides , etc.)
14.Subjects with severe vitamin D deficiency (serum 25-OH-vitamin D less than 10 ng/ml)
15.Subjects who participate in other clinical trials within the past 3 months or have plans to participate in other clinical trials during this study period
16.Subjects who determine ineligible by the principal investigator or the co-investigator
36
1st name | Satoshi |
Middle name | |
Last name | Takasugi |
Meiji Co., Ltd.
R&D Division
192-0919
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
+81-42-632-5810
satoshi.takasugi@meiji.com
1st name | Satoshi |
Middle name | |
Last name | Takasugi |
Meiji Co., Ltd.
R&D Division
192-0919
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
+81-42-632-5810
satoshi.takasugi@meiji.com
Meiji Co., Ltd.
Meiji Co., Ltd.
Profit organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
2F,Daiwa Bldg.3-3-10 Nihonbashi Hongokucho,Chuo-ku,Tokyo 103-0021 Japan
+81-3-6225-9005
IRB@cpcc.co.jp
YES
MIJ22C2
CPCC Company Limited
2022-002
Meiji Co., Ltd.
2022 | Year | 08 | Month | 09 | Day |
Unpublished
36
Completed
2022 | Year | 07 | Month | 19 | Day |
2022 | Year | 07 | Month | 15 | Day |
2022 | Year | 08 | Month | 10 | Day |
2022 | Year | 12 | Month | 01 | Day |
2022 | Year | 07 | Month | 22 | Day |
2023 | Year | 07 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055186
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |