UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039229
Receipt number R000044733
Scientific Title A Facility-Randomized, Open-Label, Cross-Over Study to Evaluate the Effect of Pecan Consumption on Caregiver Burden Score in Nursing Care Facility for Dementia Person
Date of disclosure of the study information 2020/01/22
Last modified on 2021/01/22 12:17:45

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Basic information

Public title

Study of Effect of Pecan Consumption on Caregiver Burden for Dementia Person

Acronym

GP-001 Study

Scientific Title

A Facility-Randomized, Open-Label, Cross-Over Study to Evaluate the Effect of Pecan Consumption on Caregiver Burden Score in Nursing Care Facility for Dementia Person

Scientific Title:Acronym

GP-001 Study

Region

Japan


Condition

Condition

Dementia

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm whether pecan consumption improves the caregiver burden for dementia person or not

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Caregiver burden evaluated by Japanese version of the Zarit Burden Interview with slight modification. Evaluation will be done at baseline and 3 months after pecan consumption.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

All patients are received 5 pieces of pecan everyday 10 am for 3 months.
After the completion of 2nd period of the cross-over study, all patients are received 5 pieces of pecan everyday 10 am for additional 9 months as extension period.

Interventions/Control_2

As positive control, patients are received any snack chosen by caregiver everyday 10 am for 3 months.
After the completion of 2nd period of the cross-over study, all patients are received 5 pieces of pecan everyday 10 am for additional 9 months as extension period.

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

Person who can bite and swallow by oneself

Key exclusion criteria

Patients with cancer or autoimmune disease

Target sample size

36


Research contact person

Name of lead principal investigator

1st name Mamoru
Middle name
Last name Yanagimachi

Organization

Golden Pecan Co., Ltd.

Division name

Research Division

Zip code

029-2205

Address

Nishiwano 26-1, Takatacho, Rikuzentakata-shi, IWATE

TEL

0192-22-8341

Email

d120041@tokyo-med.ac.jp


Public contact

Name of contact person

1st name Mamoru
Middle name
Last name Yanagimachi

Organization

Golden Pecan Co., Ltd.

Division name

Research Division

Zip code

029-2205

Address

Nishiwano 26-1, Takatacho, Rikuzentakata-shi, IWATE

TEL

0192-22-8341

Homepage URL


Email

d120041@tokyo-med.ac.jp


Sponsor or person

Institute

Matsubara-en, Medical Corporation Syoukyukai

Institute

Department

Personal name



Funding Source

Organization

City of Rikuzentakata

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical committee in Medical Corporation Syoukyukai

Address

Nakata 69-2, Takatacho, Rikuzentakata-shi, IWATE

Tel

0192-53-1877

Email

Kangobucyo-takata@shokyukai.or.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

2020 Year 01 Month 22 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

34

Results

Thirty-one and 33 patients completed the course of treatments for control snack and pecan, respectively. Changes in the Zarit burden interview score from baseline were significantly different between groups (control, 0.87+/-2.92; pecan, -1.00+/-2.98; p=0.015), suggesting pecan consumption improved the caregiver burden in comparison to any snack chosen by caregiver. No differentiation on HDS-R and other parameters between groups was seen. Adverse event was not observed in both groups.

Results date posted

2021 Year 01 Month 22 Day

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

2018 Year 11 Month 01 Day

Date of IRB

2018 Year 12 Month 19 Day

Anticipated trial start date

2019 Year 01 Month 01 Day

Last follow-up date

2020 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2020 Year 09 Month 01 Day

Date analysis concluded

2020 Year 09 Month 14 Day


Other

Other related information



Management information

Registered date

2020 Year 01 Month 22 Day

Last modified on

2021 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044733


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name