UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053685 |
|---|---|
| Receipt number | R000060435 |
| Scientific Title | Effects of lysolecithin intake on brain function and blood choline concentration: A randomized, double-blinded, placebo-controlled trial in healthy middle-aged and elderly volunteers |
| Date of disclosure of the study information | 2024/02/22 |
| Last modified on | 2024/02/22 16:14:03 |
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Basic information
Public title
Effects of lysolecithin intake on brain function in healthy middle-aged and elderly volunteers
Acronym
Effects of lysolecithin intake on brain function
Scientific Title
Effects of lysolecithin intake on brain function and blood choline concentration: A randomized, double-blinded, placebo-controlled trial in healthy middle-aged and elderly volunteers
Scientific Title:Acronym
Effects of lysolecithin intake on brain function: A randomized, double-blinded, placebo-controlled trial in healthy volunteers
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of lysolecithin intake on brain function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Memory scores assessed using the Wechsler Memory Scale-Revised
Key secondary outcomes
･Performance on a calculation task
･Mental functions assessed using a visual analog scale
･Blood concentrations of choline and lysophosphatidylcholine
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
Intake of placebo capsules for 8 weeks
Interventions/Control_2
Intake of lysolecithin capsules for 8 weeks
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Provided written informed consent to participate in the study
2. Healthy adults aged 40-74 years at the time of the consent
Key exclusion criteria
1. A self-reported history of brain, nerve, or mental disorders, which the Clinical Investigator believes confounds the interpretation of the study results
2. Having a sleep problem
3. Having a digestive problem or a history of digestive disorders, which the Clinical Investigator believes affects the absorption of the test supplement
4. Taking medicines or supplements that could affect brain, nerve, or mental function or sleep within 1 week of study commencement
5. Having a blood pressure or pulse rate that extremely deviates from the normal range
6. Having soy allergy
7. Not meeting certain criteria related to visual acuity
8. Other conditions judged by the Clinical Investigator to be inappropriate for the study
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Hamada |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho, Kanzaki-gun, Saga, Japan
TEL
+81-952-52-1522
hamadako@otsuka.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Tanaka-Kanegae |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho, Kanzaki-gun, Saga, Japan
TEL
+81-952-52-1522
Homepage URL
Tanaka.Ryohei@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., 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
Hakata Clinic Institutional Review Board
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka 812-0025, Japan
Tel
+81-92-283-7701
miyako-koga@lta-med.com
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
医療法人相生会ピーエスクリニック
SOUSEIKAI PS Clinic
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 22 | 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
46
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The analysis has not been completed.
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
| 2017 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 16 | 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 | 22 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060435
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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