UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053618 |
|---|---|
| Receipt number | R000061192 |
| Scientific Title | Trial of the efficacy of multi-factorial lifestyle intervention with food ingredients on cognitive function in older people (SWE-2023-09-HBPUFA) |
| Date of disclosure of the study information | 2024/02/16 |
| Last modified on | 2024/02/16 15:48:03 |
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Basic information
Public title
Trial of the efficacy of multi-factorial lifestyle intervention with food ingredients on cognitive function in older people (SWE-2023-09-HBPUFA)
Acronym
Trial of the efficacy of multi-factorial lifestyle intervention with food ingredients on cognitive function in older people
Scientific Title
Trial of the efficacy of multi-factorial lifestyle intervention with food ingredients on cognitive function in older people (SWE-2023-09-HBPUFA)
Scientific Title:Acronym
Trial of the efficacy of multi-factorial lifestyle intervention with food ingredients on cognitive function in older people
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of multi-factorial lifestyle intervention with food ingredients on cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function composite score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Daily intake of test food and lifestyle intervention for 28 weeks
Interventions/Control_2
Daily intake of control food for 28 weeks (without lifestyle intervention)
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
| 55 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Women and men aged 55 to 74 years.
2) Person who has self-identified forgetfulness.
3) Person whose score of neuropsychological test was higher than a certain score.
4) Person who can understand the purpose and content of this study and agree in writing to participate in this study.
Key exclusion criteria
1) Person who has difficulty in implementation of neuropsychological test.
2) Person whose score of neuropsychological test was higher than a certain score.
3) Use of product affecting the data of this study, such as medicine and food for specified health use.
4) Presence of previous and present serious disease such as neurological disorder, psychiatric disorder, liver disorder, kidney disorder, lung disorder, cardiovascular disorder, diabetes mellitus, food allergy.
5) Investigator's judgment for other reason.
Target sample size
122
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Kaneda |
Organization
Suntory Wellness Limited
Division name
Institute for Science of Life
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL
050-3182-0654
Yoshihisa_Kaneda@suntory.co.jp
Public contact
Name of contact person
| 1st name | Hisanori |
| Middle name | |
| Last name | Tokuda |
Organization
Suntory Wellness Limited
Division name
Institute for Science of Life
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL
050-3182-0662
Homepage URL
Hisanori_Tokuda@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
Funding Source
Organization
Suntory Wellness 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.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 | 02 | Month | 16 | 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
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 26 | 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 | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061192
| Research Plan | |
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| 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 |
