UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041812
Receipt number 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 2021/09/17 17:22:56

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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 or person

Institute

Institute of Development, Aging and Cancer, Tohoku University.

Institute

Department

Personal name



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

No longer recruiting

Date of protocol fixation

2020 Year 09 Month 02 Day

Date of IRB

2020 Year 10 Month 01 Day

Anticipated trial start date

2020 Year 10 Month 01 Day

Last follow-up date

2021 Year 09 Month 30 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

2021 Year 09 Month 17 Day



Link to view the page

Value
https://center6.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