UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053324 |
|---|---|
| Receipt number | R000060862 |
| Scientific Title | Search for nutritional supplements to enhance the effects of exercise on cognitive function - a randomized controlled trial in the field- |
| Date of disclosure of the study information | 2024/01/11 |
| Last modified on | 2024/05/08 07:18:30 |
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Basic information
Public title
Search for nutritional supplements to enhance the effects of exercise on cognitive function
Acronym
Nutritional supplements to enhance the effects of exercise on cognitive function
Scientific Title
Search for nutritional supplements to enhance the effects of exercise on cognitive function - a randomized controlled trial in the field-
Scientific Title:Acronym
Nutritional supplements to enhance the effects of exercise on cognitive function- a randomized controlled trial-
Region
| Japan |
Condition
Condition
mild cognitive impairment
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To search for nutritional supplements to enhance the effects of exercise on cognitive function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Cognitive function
2) Peak aerobic capacity
Key secondary outcomes
1) Time response to a specific frequency of sound
2) Heart rate response at the start of fast walking
3) Blood components
4) Exercise intensity and volume (time) during interval walking training
5) Physical characteristics (height and body mass) and blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Sports nutritional supplements
Interventions/Control_2
Milk products
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who are more than 60 yr old and less than 90 yr old at their agreement to participating in the study
2) Those who can walk independently with no help by others
3) Those who have not performed interval walking training
4) Those who show no allergic response to the test foods
5) Those who show their agreement to the participating in the study by documents after they receive detailed explanation about the study.
Key exclusion criteria
1) Those who do not meet the key inclusion criteria stated above
2) Those who are judged as inappropriate for the subjects of the study by the lead principal investigator
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2682
masuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2682
Homepage URL
masuki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Shinshu University Graduate School of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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 | 01 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2028 | 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 | 01 | Month | 11 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060862
