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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039229
Receipt No. 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

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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
Institute Matsubara-en, Medical Corporation Syoukyukai
Institute
Department

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
URL(English) https://upload.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


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