UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056489 |
|---|---|
| Receipt number | R000064551 |
| Scientific Title | Research on the effects of chocolate containing cacao flavanols on preventing cognitive decline and improving cognitive function |
| Date of disclosure of the study information | 2024/12/19 |
| Last modified on | 2024/12/18 12:40:12 |
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Basic information
Public title
Research on the effects of chocolate containing cacao flavanols on preventing cognitive decline and improving cognitive function
Acronym
Research on the effects of chocolate containing cacao flavanols on preventing cognitive decline and improving cognitive function
Scientific Title
Research on the effects of chocolate containing cacao flavanols on preventing cognitive decline and improving cognitive function
Scientific Title:Acronym
Research on the effects of chocolate containing cacao flavanols on preventing cognitive decline and improving cognitive function
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effects of cocoa flavanol on the prevention of cognitive decline and improvement of cognitive function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in composite score for cognitive function in cognitive function assessment at initial evaluation and 12 months
Key secondary outcomes
1) Presence or absence of changes in blood data from the initial evaluation to the 3-, 6-, and 12-month follow-up evaluations (confirmation of safety)
2) Change in each cognitive function test from the initial assessment to the 6- and 12-month follow-up assessments
3) Change in motor function assessment from the initial assessment to the 6- and 12-month follow-up assessments
4) Presence or absence of change in vascular function from the initial assessment to the 6- and 12-month follow-up assessments
5) Presence or absence of change in intestinal bacterial flora from the initial assessment to the 6- and 12-month follow-up assessments
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Once a day (can be divided into up to three times), orally ingest 25 g of chocolate containing cacao flavanols per day.
Interventions/Control_2
Once a day (can be divided into up to three times), orally ingest 25 g of chocolate per day containing cacao flavanols, tocotrienols, and vitamin D.
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants who have used a center-based cognicare program for at least 3 months, and who are aged between 60 and 85 years old
Written consent must be obtained
Key exclusion criteria
People with dementia or mild cognitive impairment (MMSE score of less than 26)
People who have been assessed as requiring long-term care level 1 or above
People who have been assessed as having severe liver or kidney dysfunction
People with a history of allergy to cacao
People who consume chocolate or cocoa on a daily basis
People who the researchers have judged to be unsuitable for the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisatomo |
| Middle name | |
| Last name | Kowa |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Rehabilitation Science
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku Kobe 654-0142, Japan
TEL
078-796-4502
kowa@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisatomo |
| Middle name | |
| Last name | Kowa |
Organization
Kobe University Graduate School of Health Sciences
Division name
Dementia Preventing Center
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku Kobe 654-0142, Japan
TEL
078-796-4502
Homepage URL
kowa@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Sciences Health Science Ethics Committee
Address
7-10-2 Tomogaoka, Suma-ku Kobe 654-0142, Japan
Tel
078-796-4502
kowa@med.kobe-u.ac.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
| 2024 | Year | 12 | Month | 19 | 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
102
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064551
