UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050155 |
|---|---|
| Receipt number | R000055618 |
| Scientific Title | The effect of diet and macrophage activation factor on cognitive function in eldely outopatiant rehabilitation: randomized control trial |
| Date of disclosure of the study information | 2023/01/27 |
| Last modified on | 2023/02/14 22:31:38 |
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Basic information
Public title
The effect of diet intervention and MAFcapsules on congnitve function in elderly peopleusing outpatiant rehabilitation
Acronym
The effect of diet intervention and MAF capsules on cognitive function in elderly people with rehabilitation
Scientific Title
The effect of diet and macrophage activation factor on cognitive function in eldely outopatiant rehabilitation: randomized control trial
Scientific Title:Acronym
The effect of diet and MAF on cognitive function in eldely outopatiant rehabilitation: randomized control trial
Region
| Japan |
Condition
Condition
Elderly persons using day rehabilitation facilities
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study will examine the effects on cognitive function of exercise, dietary modification, or continuous intake of MAF (Macrophage Activating Factor) capsules in elderly patients aged 65 years or older who use day-care rehabilitation facilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive function tests: MCI Screen (Mild Cognitive Impairment)
Key secondary outcomes
1) Degree of senescence: AGE value
2) Plasma amyloid beta 40/42 ratio
3) General blood collection: blood count, hemogram, ferritin, folic acid, vitamin B12, B1, CRP, HbA1c, 1/5 AG, fT4, TSH, GOT, GPT, ALB, BUN, Cr, Na, K, Cl, Zn, Cu, 1,25-(OH)VitD
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom | Other |
Interventions/Control_1
Dietary guidance (after detailed interviews, provide guidance on a diet with a low inflammation index to the extent possible) plus placebo (2 capsles per day)
Interventions/Control_2
Dietary guidance + MAF capsules taken (2 capsules per day)
Interventions/Control_3
Normal rehabilitation plus placebo (2 capsules per day)
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
Male and Female
Key inclusion criteria
1) 65 years of age or older
2) Those who have been using an outpatient rehabilitation facility
3) Those who have been attending the facility for more than 3 months and whose condition is stable.
Key exclusion criteria
1) Cases in which the subject has been diagnosed with severe anemia, terminal cancer, Parkinson's disease or other degenerative brain disease
2) Cases in which the research subject requests withdrawal of consent
3) When it becomes impossible to comply with the research protocol
(4) When the entire research is terminated
(5) Other cases in which the principal investigator or a subinvestigator determines that it is difficult to continue the research.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Uchiyama |
Organization
Yoko-Clinic
Division name
none
Zip code
805-0016
Address
3-3-13, Takami, Yahata-higashi-ku, Kita-Kyusyu, Fukuoka
TEL
093-651-0880
yoko-uchiyama-tanaka@yoko-clinic.net
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Uchiyama |
Organization
Yoko-Clinic
Division name
none
Zip code
805-0016
Address
3-3-13, Takami, Yahata-higashi-ku, Kita-Kyusyu, Fukuoka
TEL
093-651-0880
Homepage URL
yoko-uchiyama-tanaka@yoko-clinic.net
Sponsor or person
Institute
Saisei Immunotherapy Clinics
Institute
Department
Personal name
Toshio Inui
Funding Source
Organization
Saisei Immunotherapy Clinics
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
So-Shin-Kai Cop.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KONAN UNIVERSITY
Address
7-1-20 Minatojima-minami Chu-o-ku Kobe
Tel
078-303-1457
first@adm.konan-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-001
Org. issuing International ID_1
KONAN UNIVERSITY
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
葉子クリニック
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 27 | 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
43
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
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is double-blind with respect to drug intervention, but open with respect to the presence or absence of dietary guidance.
Management information
Registered date
| 2023 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055618
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
