UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042666 |
|---|---|
| Receipt number | R000048062 |
| Scientific Title | Study on the effect of plant-derived bioactive components on cognitive functions in the healthy elderly subjects. |
| Date of disclosure of the study information | 2020/12/05 |
| Last modified on | 2023/12/08 10:23:58 |
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Basic information
Public title
Study on the effect of plant-derived bioactive components on cognitive functions in the healthy elderly subjects.
Acronym
Study on the effect of plant-derived bioactive components on cognitive functions in the healthy elderly subjects.
Scientific Title
Study on the effect of plant-derived bioactive components on cognitive functions in the healthy elderly subjects.
Scientific Title:Acronym
Study on the effect of plant-derived bioactive components on cognitive functions in the healthy elderly subjects.
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect of plant-derived bioactive components on cognitive functions in the healthy elderly subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symbol coding/Symbol search, Digit Span
Key secondary outcomes
Cognitive functions (stroop, Letter-Number Sequence, Logical memory, design memory, visual recall 1, visual paired assoicate 1)
Mental health (WHO5: WHO-Five well-being index, POMS: Profile of Mood States)
Pittsburgh Sleep Quality Index,
International Physical Activity Questionnaire
Metabolites of plant derived components,
Heme Oxygenase 1
Glutathione S-transferase
tumor necrosis factor-alpha
brain derived neurotrophic factor
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
Intake test food containing plant-derived bioactive components for 12 weeks.
Interventions/Control_2
Intake placebo (without plant-derived bioactive components) for 12 weeks.
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
| 81 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese healthy elderly subjects who are native Japanese speaker and agreed to participate in this study
Key exclusion criteria
1. Those suffering from mental illness, diabetes, neurological disease, heart disease (cardiac disease), or other serious illnesses.
2. Those who are taking medicine that affect cognitive function (eg benzodiazepines, antidepressants, central nervous system medicine)
3. Those who have a history of serious illnesses in the past and are judged to have problems participating in this study.
4. Those who have a score of 26 points or less in the MMSE (Mini Mental State Examination), a screening test for dementia.
5. Those who have a Geriatric Depression Scale of 5 or more, which is a test to check the degree of depression.
6. Those who have a score of 12 points or less on the frontal assessment battery at bedside (FAB), a frontal lobe function test.
7. Those who have a score of less than 85 in the simple IQ estimation test by JART
8. Those who may have allergies to food (especially those who are allergic to broccoli, milk, eggs, wheat, buckwheat, peanuts, shrimp, crabs)
9. Those who have a drinking habit of more than 60 g of pure alcohol as average daily drinking amount on weekly basis.
10. Those who are currently participating in other studies, or who have participated in other studies within 2 months.
11. Those who cannot refrain from using medicines and health foods (including supplements, foods for specified health use, foods with health claims, aojiru, energy drinks) that may affect the test values, during the test period.
12. Those who are unable to intake the test food or placebo as instructed during the test period, or those who cannot fill in the life diary
13. Others who are determined by the principal investigator as inappropriate subjects.
Target sample size
144
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ushida |
Organization
Innovation Division, Kagome Co., Ltd.
Division name
Nature and Wellness Research Department
Zip code
3292762
Address
17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL
+81-287-36-2935
Yusuke_Ushida@kagome.co.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
1050023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
Innovation Division, Kagome Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Innovation Division, Kagome Co., Ltd.
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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.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 | 12 | Month | 05 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35966784/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35966784/
Number of participants that the trial has enrolled
144
Results
he SFN group showed improvement in processing speed and a decrease in negative mood compared to the placebo group. In addition, the SFN group exhibited a higher SFN-N-acetyl-L-cysteine (NAC) level compared to the placebo group. However, there were no significant results in other biomarkers of oxidant stress, inflammation, or neural plasticity.
Results date posted
| 2023 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Elderly Japanese men and women with no abnormalities in MMSE, FAB, JART, and GDS.
Participant flow
After obtaining informed consent from 321 candidates, a screening test was conducted. Taking into account test results and exclusion criteria, 144 patients were included in the intervention.
Adverse events
No event observed
Outcome measures
Cognitive functioning, Emotional state, and blood biomarkers
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 05 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048062
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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