UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038605
Receipt number R000043995
Scientific Title Effect of nutritional programs on cognitive function and sleep quality in a community-dwelling older Japanese
Date of disclosure of the study information 2021/03/31
Last modified on 2021/05/19 09:05:00

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Basic information

Public title

Effect of nutritional programs on cognitive function and sleep quality in a community-dwelling older Japanese

Acronym

Effect of nutritional programs on cognitive function and sleep quality

Scientific Title

Effect of nutritional programs on cognitive function and sleep quality in a community-dwelling older Japanese

Scientific Title:Acronym

Effect of nutritional programs on cognitive function and sleep quality

Region

Japan


Condition

Condition

Community dwelling older adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the effect of dietary program on the cognitive function and sleep quality in a community-dwelling older Japanese

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitive function

Key secondary outcomes

Sleep quality


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

Behavior,custom

Interventions/Control_1

Intervention group: nutritional program to improve dietary diversity (6 months)

Interventions/Control_2

Control group

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Individuals who participate in the health promotion programs in Meiwa-machi, Gunma

Key exclusion criteria

Individuals who have difficulty in daily life without social support, who have dietary restriction such as dialysis treatment, and who are diagnosed as a sleep disorders

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Takahiro
Middle name
Last name Yoshizaki

Organization

Toyo University

Division name

Department of Food and Life Sciences, Faculty of Food and Nutritional Sciences

Zip code

374-0193

Address

1-1-1, Izumino, Itakura-machi, Ora-gun, Gunma 374-0193, Japan

TEL

0276-82-9012

Email

yoshizaki@toyo.jp


Public contact

Name of contact person

1st name Takahiro
Middle name
Last name Yoshizaki

Organization

Toyo University

Division name

Department of Food and Life Sciences, Faculty of Food and Nutritional Sciences

Zip code

374-0193

Address

1-1-1, Izumino, Itakura-machi, Ora-gun, Gunma 374-0193, Japan

TEL

0276-82-9012

Homepage URL


Email

yoshizaki@toyo.jp


Sponsor or person

Institute

Department of Food and Life Sciences, Faculty of Food and Nutritional Sciences, Toyo University

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Young Scientists(B), Japan Society for the Promotion of Science, The Ministry of Education,Culture,Sports,Science and Technology

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Toyo University

Address

2100, Kujirai, Kawagoe city, Saitama, 350-8585, Japan

Tel

049-239-1440

Email

hoshi@toyo.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

2021 Year 03 Month 31 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

Terminated

Date of protocol fixation

2019 Year 07 Month 20 Day

Date of IRB

2019 Year 10 Month 03 Day

Anticipated trial start date

2020 Year 01 Month 10 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 11 Month 17 Day

Last modified on

2021 Year 05 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043995


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name