UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053369 |
|---|---|
| Receipt number | R000060910 |
| Scientific Title | Clinical study to examine the effects of food ingredient extracts in people with mild cognitive impairment |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2024/01/16 15:29:10 |
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Basic information
Public title
Clinical study to examine the effects of food ingredient extracts in people with mild cognitive impairment
Acronym
Research to verify the effects of food ingredient extracts in people with mild cognitive impairment
Scientific Title
Clinical study to examine the effects of food ingredient extracts in people with mild cognitive impairment
Scientific Title:Acronym
Research to verify the effects of food ingredient extracts
Region
| Japan |
Condition
Condition
mild cognitive impairment
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether continuous intake of java ginger extract is effective in preventing cognitive decline, improving taste, and preventing infection in mildly cognitively impaired patients, with the primary endpoint of improvement in cognitive function after 6 months of continuous intake, and to compare changes with those before the intervention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MMSE (Cognitive function test)
Key secondary outcomes
Evaluation using a brain activity balancer
Height, weight, body composition
Taste test (Taste Disc)
Survey of motivation for daily life using Q-ESD
Survey of lifestyle and eating habits using FFQ
Time up and Go to test
Grip strength
Oral microflora test using saliva sampling
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A pre-intervention survey will be conducted on the subjects, and food extract powder will be continuously consumed twice a day, morning and evening, before, 3 months, and 6 months of intake will be compared.
Interventions/Control_2
A pre-intervention survey will be conducted on the subjects, and placebo will be continuously consumed twice a day, morning and evening, before, 3 months, and 6 months of intake will be compared.
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
| 65 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly persons who are in good health and have maintained their daily functions but have mild cognitive decline, and who have given consent for the study.
Those who have an MMSE score between 24 and 27.
Gender: male and female
Age: 65 years and older
Age: 65 years old or older
Organ function: No obvious abnormal values in blood tests
Key exclusion criteria
(1) Those suffering from serious cerebrovascular disease, cardiac disease, liver disease, renal disease, gastrointestinal disease, or infectious disease requiring notification
(2) Those diagnosed with obvious dementia
(3) Those with chronic diseases (diabetes, heart disease, liver failure, renal failure, gastric/duodenal ulcer, colitis,
Crohn's disease, cancer, etc.) who are receiving treatment or medication
(4) Persons with familial hypercholesterolemia
(5) Those with significant abnormalities in blood pressure measurements or blood tests
(6) Patients with severe anemia or bleeding tendency
(7) Persons with frequent symptoms of diarrhea
(8) Persons who may show allergic symptoms to the test sample
(9) Patients who are regular users of excessive smoking and alcohol, and those who have extremely irregular lifestyles in terms of diet, sleep, etc.
(10)Persons who are currently participating or have participated within one month in other clinical trials.
(11)Other subjects who are judged to be ineligible by the study sponsor.
Translated with www.DeepL.com/Translator (free version)
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sakaue |
Organization
Tokushima University Graduate School
Division name
Department of Nutrition and Metabolism, Institute of Biomedical sciences
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
+819019150327
hsakaue@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | sakaue |
Organization
Tokushima University Graduate Schoo
Division name
Institute of Biomedical sciences
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
0886339249
Homepage URL
hsakaue@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
self-financing
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho Tokushima
Tel
0886339295
awachiken@tokushima-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
| 2025 | Year | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 15 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060910
