UMIN-CTR Clinical Trial

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