UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052043 |
|---|---|
| Receipt number | R000058932 |
| Scientific Title | A pilot study of the effects of a daily foods containing plant extracts in the patients with mild cognitive impairment due to Alzheimer's disease |
| Date of disclosure of the study information | 2023/08/29 |
| Last modified on | 2025/04/18 08:30:47 |
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Basic information
Public title
A pilot of study of effects of a daily foods containing plant extracts in patients with mild cognitive impairment due to Alzheimer's disease
Acronym
A pilot study of the effects of a daily foods containing plant extracts in the patients with mild cognitive impairment due to Alzheimer's disease
Scientific Title
A pilot study of the effects of a daily foods containing plant extracts in the patients with mild cognitive impairment due to Alzheimer's disease
Scientific Title:Acronym
A pilot study of the effects of a daily foods containing plant extracts in the patients with mild cognitive impairment due to Alzheimer's disease
Region
| Japan |
Condition
Condition
MCI
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examine the effect of 16-weeks ingestion of a food containing plant extracts for improving Amyloid-beta-related peptides in blood in patients (males and females) with MCI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At 0, 8, 16 weeks in the intervention
(1) Amyloid-beta-related composit marker in blood assessed by Amyloid MS CL AXIMA
(2) Trail Making Test-A/B
(3) MoCA-J
(4) NouKNOW
Key secondary outcomes
At 0, 8, 16 weeks in the intervention
(1) C-reactive protein (CRP)
(2) Tumor necrosis factor (TNF)-alpha
(3) Brain-derived neurotrophic factor (BDNF)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the test product with a plant extract (2 capsules per a day; 16 weeks)
Interventions/Control_2
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
| 45 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients who diagnosed with Alzheimer's disease (AD) in Yokohama Shintoshi Neurosurgical Hospital
(2) Patients who are MCI cognitive impairment with CDR 0.5 or less, and FAST stage 2 or 3
(3) An adult males and females from 45 to 90 years of age, and have no comorbidity or history of malignancies, serious liver disease, or other serious internal disorder
(4) Patients who participate in this study with a verbal and written informed consent.
(5) Patients who can take 2 capsules of turmeric product per day
Key exclusion criteria
(1) Patients who are Alzheimer's disease (AD) with CDR 1 or over, and FAST stage 4 or over
(2) Patients who are Mild Cognitive Impairment (MCI) not due to AD
(3) An adult males and females under 45 or over 90 years of age, and have comorbidity or history of malignancies, serious liver disease, or other serious internal disorder
(4) Patients who take drugs, quasi-drug or health food on a daily basis, such as Docosahexaenoic Acid (DHA), eicosapentaenoic acid (EPA), Ginkgo biloba extract, linseed oil, tocotrienols, tocopherols, astaxanthin, Gamma Amino Butyric Acid (GABA), phosphatidylserine, and plasmalogen.
(5) Patients who have extremely irregular dietary habits
(7) Patients who have excessive alcohol-drinking or
(8) Patients who are smoker
(9) Patients who have soy allergy
(10) Patients who have plan to participate in other trial during scheduled period in this trial
(11) Patients judged as unsuitable for the study by the investigators
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Manabe |
Organization
Kanagawa Dental University
Division name
School of Dentistry
Zip code
2388580
Address
1-23 Ogawa-cho, Yokosuka-shi, Kanagawa
TEL
046-845-3177
manabe.epikuros@gmail.com
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Saji |
Organization
House Wellness Foods Corporation
Division name
Research and Development Institute Material Research Division
Zip code
6640011
Address
Imoji 3-20, Itami, Hyogo
TEL
072-778-1127
Homepage URL
ryosuke.saji.hy8@housefoods.co.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
House Wellness Foods Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Yokohama Shintoshi Neurosurgical Hospital
Address
433 Eda-chou, Aoba-Ku, Yokohama, JAPAN 225-0013
Tel
045-911-2011
shintoshi-ikyoku@ims.r.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
| 2023 | Year | 08 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058932
