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
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
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
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
