UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036684
Receipt number R000041778
Scientific Title Evaluation of the effect of dairy product on health status of elderly people
Date of disclosure of the study information 2019/05/08
Last modified on 2023/05/23 13:35:40

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Basic information

Public title

Evaluation of the effect of dairy product on health status of elderly people

Acronym

Evaluation of the effect of dairy product on health status of elderly people

Scientific Title

Evaluation of the effect of dairy product on health status of elderly people

Scientific Title:Acronym

Evaluation of the effect of dairy product on health status of elderly people

Region

Japan


Condition

Condition

Elderly

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Elderly residing in nursing home are enrolled and participants are divided into two groups. The elderly in one group take a daily drink every day for 1 year and those in another does not. Effects of the daily drink on nutritional status of the elderly are evaluated through body weight and blood parameters during the intervention. Effects on defecation status, disease history and immune parameter are also evaluated. In addition, fecal microbiota are evaluated every 6 month during intervention and its relation with other evaluations are analyzed.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Nutritional status

Key secondary outcomes

1) Fecal microbiota
2) Bowel movement (fecal appearance, frequency)
3) Bacterial metabolite in feces
4) Fecal protein
5) Medication history
6) Morbidity of infectious diseases
7) Immune function


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

1-year intervention of dairy drink (one bottle per day)

Interventions/Control_2

Non-treatment

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Nursing home residents of Benesse Style Care Co., Ltd.

Key exclusion criteria

1) Milk allergy
2) Participation in other clinical trial
3) Unable to receive oral intake
4) Not suitable for the study

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Taisaku
Middle name
Last name Okumura

Organization

Benesse Style Care Co., Ltd.

Division name

Benesse Institute for Research on KAIGO (Continuing Care)

Zip code

163-0905

Address

Shinjuku Monolith Building 2-3-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-6836-1111

Email

okumra-t@benesse-style-care.co.jp


Public contact

Name of contact person

1st name Ryoko
Middle name
Last name Fukuda

Organization

Benesse Style Care Co., Ltd.

Division name

Benesse Institute for Research on KAIGO (Continuing Care)

Zip code

163-0905

Address

Shinjuku Monolith Building 2-3-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-6836-1075

Homepage URL


Email

fukuda-ryoko@benesse-style-care.co.jp


Sponsor or person

Institute

Benesse Institute for Research on KAIGO (Continuing Care)

Institute

Department

Personal name



Funding Source

Organization

Benesse Institute for Research on KAIGO (Continuing Care)

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Yakult Central Institute

Name of secondary funder(s)

Yakult Central Institute


IRB Contact (For public release)

Organization

Ethics Committee of Benesse Institute for Research on KAIGO (Continuing Care)

Address

Shinjuku Monolith Building 2-3-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan

Tel

03-6836-1111

Email

hi-nagata@benesse-style-care.co.jp


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



Other administrative information

Date of disclosure of the study information

2019 Year 05 Month 08 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


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

2019 Year 05 Month 03 Day

Date of IRB

2019 Year 05 Month 03 Day

Anticipated trial start date

2019 Year 05 Month 09 Day

Last follow-up date

2021 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 05 Month 08 Day

Last modified on

2023 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041778


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name