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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041812
Receipt No. R000047737
Scientific Title Effects of Beta-lactolin intakes with cognitive training on neural systems in the healthy older adults.
Date of disclosure of the study information 2020/09/17
Last modified on 2020/09/16

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Basic information
Public title Effects of Beta-lactolin intakes with cognitive training on neural systems in the healthy older adults.
Acronym Effects of Beta-lactolin intakes with cognitive training on neural systems in the healthy older adults.
Scientific Title Effects of Beta-lactolin intakes with cognitive training on neural systems in the healthy older adults.
Scientific Title:Acronym Effects of Beta-lactolin intakes with cognitive training on neural systems in the healthy older adults.
Region
Japan

Condition
Condition The healthy older adults.
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effects of cognitive interventions and nutrition interventions of Beta-lactolin intake on changes in resting brain activity in healthy older adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Brain MRI data
Key secondary outcomes Cognitive function test scores: A Frontal assessment battery at bedside, Stroop test, Trail Making Test, Verbal fluency task, Mini-Mental State Examination, Raven's Progressive Matrices, Japanese Reading Ability Test, Logical Memory, Rivermead Behavioral Memory Test, visual paired-associates, Standard verbal paired-associate learning test, Digit Span Task, Memory Updating Task, Digital Cancellation Test, Digit Symbol-Coding, Symbol Search, Mental Rotation Task.
Questionnaire test scores: State-Trait Anxiety Inventory, WHO-Five well-being index, General Health Questionnaire 12, Profile of Mood States, Center for epidemiologic studies depression scale, Geriatric Depression Scale, Subjective cognitive decline questionnaire, Two dimensional mood scale, and Apathy Scale, Pittsburgh Sleep Quality Index, Eating Habits, Ten Item Personality Inventory, Effortful Control Scale.

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 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 Beta-lactolin (Once a day for six weeks) & cognitive training game (25 minutes daily for six weeks)
Interventions/Control_2 Placebo (Once a day for six weeks) & cognitive training game (25 minutes daily for six weeks)
Interventions/Control_3 Beta-lactolin (Once a day for six weeks) & active control game (25 minutes daily for six weeks)
Interventions/Control_4 Placebo (Once a day for six weeks) & active control game (25 minutes daily for six weeks)
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 120 healthy, right-handed, whose first language is Japanese, elderly men and women (age: 60 years and older, 75 years and younger). Those who do not regularly play games (less than 1 hour per week of games (including videos, computers, and smartphones) in the past 2 years). Those who are able to participate in a pre-test from 1 week before to the day before the intervention period, a 6-week intervention period, and a post-test from the day after the last day of the intervention to 1 week after.
Key exclusion criteria 1. A person who continuously consumes whey enzyme-degraded enzyme-enriched foods, health foods, foods for specified health uses, foods with nutrient function, or functional foods at least once a week.
2. Taking protein-rich supplements (high-protein supplements) or foods (foods highlighted as "high-protein") for the purpose of increasing muscle strength at least once a week on a continuous basis.
3. Those who continuously consume medicines, health foods, food for specified health uses, food with nutrient function, or food with functional labeling for the purpose of improving cognitive function at least once a week.
4. Those with major life changes planned during the study period.
5. A person who constantly consumes more than the appropriate amount of alcohol (about 20 g of alcohol per day on a daily basis: about 1 medium bottle of beer, about 180 mL of wine, about 1 glass of sake, about 60 mL of whiskey double).
6. Those with a history of mental illness, diabetes, neurological disease, or heart disease (cardiac disease), or those with an MMSE score of 26 or less.
7. Smokers or those who have begun to quit smoking within 12 months prior to the pretest.
8. Currently participating in another study or participating in another clinical trial within the month prior to the pretest.
9. Taking medications that affect cognitive function (e.g., benzodiazepines, antidepressants, central nervous system drugs).
10. Those judged to be unsuitable as subjects based on their responses to the lifestyle questionnaire.
11. The presence of metal in the body
12. Claustrophobia.
13. People with extreme myopia
14. People with food allergies (especially those allergic to milk, eggs, wheat, buckwheat, peanuts, shrimp, and crab).
15. Those who are lactose intolerant.
16. Who are unable to perform either game interventions or complete a life intervention diary.
Any other person who is deemed unsuitable as a subject by the physician-in-charge.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Kawashima
Middle name
Last name Ryuta
Organization Institute of Development, Aging and Cancer, Tohoku University.
Division name Department of Advanced Brain Science
Zip code 980-8575
Address 4-1, Seiryo-machi, Aoba ward, Sendai, Miyagi
TEL 022-717-7988
Email ryuta.kawashima.a6@tohoku.ac.jp

Public contact
Name of contact person
1st name Yagi
Middle name
Last name Ayano
Organization Institute of Development, Aging and Cancer, Tohoku University.
Division name Department of Cognitive Health Science
Zip code 980-8575
Address 4-1, Seiryo-machi, Aoba ward, Sendai, Miyagi
TEL 022-717-8952
Homepage URL
Email ayano.yagi.e5@tohoku.ac.jp

Sponsor
Institute Institute of Development, Aging and Cancer, Tohoku University.
Institute
Department

Funding Source
Organization Kirin Holdings Company, Limited.
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 Tohoku University Hospital, Clinical Research Ethics Committee
Address 1-1, Seiryo-machi, Aoba ward, Sendai, Miyagi
Tel 022-728-4105
Email ec@rinri.hosp.tohoku.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
2020 Year 09 Month 17 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
2020 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2021 Year 07 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
2020 Year 09 Month 16 Day
Last modified on
2020 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047737

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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