UMIN-CTR Clinical Trial

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

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Basic information

Public title

Effects of lactic acid bacteria intake on bone metabolism markers in postmenopausal women: an exploratory study

Acronym

Effects of lactic acid bacteria on bone metabolism markers: an exploratory study

Scientific Title

Effects of lactic acid bacteria intake on bone metabolism markers in postmenopausal women: an exploratory study

Scientific Title:Acronym

Effects of lactic acid bacteria on bone metabolism markers: an exploratory study

Region

Japan


Condition

Condition

N/A

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of lactic acid bacteria intake on bone metabolism markers in postmenopausal women: an exploratory study.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Bone resorption markers

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

12-week intake of active food (high dose)

Interventions/Control_2

12-week intake of active food (low dose)

Interventions/Control_3

12-week intake of placebo food

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


Not applicable

Gender

Female

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

36


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Takasugi

Organization

Meiji Co., Ltd.

Division name

R&D Division

Zip code

192-0919

Address

1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan

TEL

+81-42-632-5810

Email

satoshi.takasugi@meiji.com


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Takasugi

Organization

Meiji Co., Ltd.

Division name

R&D Division

Zip code

192-0919

Address

1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan

TEL

+81-42-632-5810

Homepage URL


Email

satoshi.takasugi@meiji.com


Sponsor or person

Institute

Meiji Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Meiji Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F,Daiwa Bldg.3-3-10 Nihonbashi Hongokucho,Chuo-ku,Tokyo 103-0021 Japan

Tel

+81-3-6225-9005

Email

IRB@cpcc.co.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

MIJ22C2

Org. issuing International ID_1

CPCC Company Limited

Study ID_2

2022-002

Org. issuing International ID_2

Meiji Co., Ltd.

IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2022 Year 08 Month 09 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

36

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

2022 Year 07 Month 19 Day

Date of IRB

2022 Year 07 Month 15 Day

Anticipated trial start date

2022 Year 08 Month 10 Day

Last follow-up date

2022 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

2022 Year 07 Month 22 Day

Last modified on

2023 Year 07 Month 23 Day



Link to view the page

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