UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042414 |
|---|---|
| Receipt number | R000048390 |
| Scientific Title | Study on the effect of food ingredients on the memory of healthy middle-aged and elderly |
| Date of disclosure of the study information | 2021/04/23 |
| Last modified on | 2023/10/11 09:13:48 |
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Basic information
Public title
Study on the effect of food ingredients on the memory of healthy middle-aged and elderly
Acronym
Study on the effect of food ingredients on the memory of healthy middle-aged and elderly
Scientific Title
Study on the effect of food ingredients on the memory of healthy middle-aged and elderly
Scientific Title:Acronym
Study on the effect of food ingredients on the memory of healthy middle-aged and elderly
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect on memory by continuously ingesting the test food for 12 weeks in healthy Japanese men and women aged 50 to 69 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MCI screen (short-term memory, long-term memory)
Key secondary outcomes
(Secondary outcomes)
Pittsburgh Sleep Quality Index,SF-36v2 Japanese version,PHQ-9 Japanese version
(Safety evaluation)
Vital signs, body measurement(weight,BMI),biochemical tests, hematological tests, adverse events
(Exploratory outcomes)
Satisfaction With Life Scale Japanese version(SWLS;screening only),Participant Background Questionnaire(screening only)
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12-weeks intake of the test food
Interventions/Control_2
12-weeks intake of the placebo food
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
| 50 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women whose age at the time of obtaining consent is aged older 50 to 69 years old.
2) Subject who is aware of in cognitive function (memory) decline.
3) Subject who has a MMSE-J score of 24 points or more.
4) PHQ-9 Japanese version with a score of 9 points or less.
5) Subject with an MPI score of 50.20 or higher for their MCI screen.
6) Immediate playback of MCI screen delayed playback less than the number of correct answers for the third time.
7) Non-smoker.
8) Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the study after understanding it well, and agreed to participate in the study in writing.
Key exclusion criteria
1.Subject who is taking medication or under medical treatment.
2.Subject who is under exercise therapy or dietetic therapy.
3.Subject who has an allergy for test food.
4.Subject who has or had a history of either medicine or alcohol dependence syndrome.
5.Subject who has or had a history of mental illness (depression) or sleep disturbance.
6.Subject who has irregular work rhythms such as working at night and shift work.
7.Subject who has extremely irregular lifestyle such as eating and sleeping.
8.Subject who has an unbalanced diet.
9.Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases.
10.Subject who uses health foods, supplements, and pharmaceuticals that affect cognitive function.
11.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
12.Subject who has blood drawn or blood component more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition.
13.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
14.Subject who can't keep the daily records.
15.Subject who is judged as an inappropriate candidate according to the screening data.
16.Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
ochitani@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
ITO EN, Ltd
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
AMC Nishi-Umeda Clinic Clinical Research Institutional Review Board
Address
West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
Tel
06-4797-5660
jimukyoku@amc-clinc.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
| 2021 | Year | 04 | Month | 23 | 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
80
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 | 10 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 22 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 10 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 26 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 11 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048390
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