UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049147 |
|---|---|
| Receipt number | R000055985 |
| Scientific Title | An open-label, before-and-after trial study as a test of the effects of exercise on cognitive function and olfactory function and their association |
| Date of disclosure of the study information | 2022/10/11 |
| Last modified on | 2023/07/10 08:29:17 |
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Basic information
Public title
The effect of exercise training on cognitive function and olfactory function
Acronym
The effect of exercise training
Scientific Title
An open-label, before-and-after trial study as a test of the effects of exercise on cognitive function and olfactory function and their association
Scientific Title:Acronym
An open-label, before-and-after trial study as a test of the effects of exercise
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of exercise training on cognitive function and olfactory score.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mini Mental State Examination (MMSE)
olfactory score
Key secondary outcomes
Questionnaires
Raven's Colored Progressive Matrices (RCPM)
Weight/body mass index
Blood pressure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
They participates in the exercise training three times a week and orally ingests the test food for 24 weeks.
Interventions/Control_2
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
| Not applicable |
Gender
Female
Key inclusion criteria
(1)Healthy women over the age of 65
(2)Subjects with a BMI of less than 25 at the time of informed consent
(3)Subjects who had no exercise habit (do not continuously do aerobic exercise and strength training)
(4)Subject who can come to the place on the day of the designated examination and undergo the examination
(5)Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria
(1)Subjects who have had an allergic reaction to a fragrance in the past
(2)Subjects who are allergic to milk or soy
(3)Subjects who are allergic to food and drugs
(4)Subjects who are undergoingdiet therapy and exercise therapy under the supervision of a doctor.
(5)Subjects who have been instructed by a doctor to limit protein or exercise
(6)Subjects with current or history of serious illness
(7)Subjects who have a serious chronic disease and are taking regular medicines
(8)Mental illness, diabetes, cranial nerve disease, heart disease (cardiac disease), depression, epilepsy or those who have a history of it
(9)Subjects with severe anemia
(10)Subjects with systolic blood pressure of 180 mmHg or higher and diastolic blood pressure of 100 mmHg or higher
(11)Subjects who have difficulty walking or exercising independently
(12)Subjects who have unintentionally lost 4.5kg or 5% or more in the last year
(13)Subjects diagnosed with an olfactory disorder with a definite cause
(14)Subjects who are judged to be unsuitable as a subject based on the results of MMSE
(15)Subjects with severe hay fever or allergic rhinitis (including seasonal and perennial) symptoms (subjects who develop allergic symptoms during the test period and take steroids)
(16)Subjects who routinely consume health foods that may affect test results
(17)Subject who plan to travel abroad during the examination period
(18)Subjects who are currently participating in studies involving the use of other foods or pharmaceuticals, studies in which cosmetics or pharmaceuticals are applied, those who have participated in other clinical studies within one month of obtaining informed consent, or who are willing to participate.
(19)Current smoker
(20)Subjects whose daily alcohol consumption exceeds an average of 60 g/day of pure alcohol equivalent.
(21)Subjects who have been judged by the principal investigator or sub-investigator to be inappropriate for this study, in addition to the reasons listed above.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Fukumoto |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Business Development Section Household Division
Zip code
541-0045
Address
KDX Kobayashi-Doshomachi Building 5F, 4-4-10, Doshomachi, Chuo-ku, Osaka City, Osaka, Japan
TEL
070-1216-8047
t.fukumoto@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
530-0044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Curves Japan Co., Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6135-5200
mterashima@miura-cl.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
| 2022 | Year | 10 | 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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 06 | 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
| 2022 | Year | 10 | Month | 07 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055985
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