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 |
Study of Effect of Pecan Consumption on Caregiver Burden for Dementia Person
GP-001 Study
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
GP-001 Study
Japan |
Dementia
Neurology |
Others
NO
To confirm whether pecan consumption improves the caregiver burden for dementia person or not
Efficacy
Confirmatory
Pragmatic
Not applicable
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.
Interventional
Cross-over
Randomized
Cluster
Open -no one is blinded
Active
2
Treatment
Food |
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.
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.
Not applicable |
Not applicable |
Male and Female
Person who can bite and swallow by oneself
Patients with cancer or autoimmune disease
36
1st name | Mamoru |
Middle name | |
Last name | Yanagimachi |
Golden Pecan Co., Ltd.
Research Division
029-2205
Nishiwano 26-1, Takatacho, Rikuzentakata-shi, IWATE
0192-22-8341
d120041@tokyo-med.ac.jp
1st name | Mamoru |
Middle name | |
Last name | Yanagimachi |
Golden Pecan Co., Ltd.
Research Division
029-2205
Nishiwano 26-1, Takatacho, Rikuzentakata-shi, IWATE
0192-22-8341
d120041@tokyo-med.ac.jp
Matsubara-en, Medical Corporation Syoukyukai
City of Rikuzentakata
Local Government
Japan
Ethical committee in Medical Corporation Syoukyukai
Nakata 69-2, Takatacho, Rikuzentakata-shi, IWATE
0192-53-1877
Kangobucyo-takata@shokyukai.or.jp
NO
2020 | Year | 01 | Month | 22 | Day |
Published
34
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.
2021 | Year | 01 | Month | 22 | Day |
Completed
2018 | Year | 11 | Month | 01 | Day |
2018 | Year | 12 | Month | 19 | Day |
2019 | Year | 01 | Month | 01 | Day |
2020 | Year | 10 | Month | 31 | Day |
2020 | Year | 09 | Month | 01 | Day |
2020 | Year | 09 | Month | 14 | Day |
2020 | Year | 01 | Month | 22 | Day |
2021 | Year | 01 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044733