UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026779 |
|---|---|
| Receipt number | R000030743 |
| Scientific Title | Effect of soy peptide supplementation on cognitive function -A paralleled, randomized, double-blind, placebo-controlled dose response study- |
| Date of disclosure of the study information | 2017/03/30 |
| Last modified on | 2018/07/13 15:59:56 |
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Basic information
Public title
Effect of soy peptide supplementation on cognitive function
-A paralleled, randomized, double-blind, placebo-controlled dose response study-
Acronym
Effect of soy peptide on cognitive function
Scientific Title
Effect of soy peptide supplementation on cognitive function
-A paralleled, randomized, double-blind, placebo-controlled dose response study-
Scientific Title:Acronym
Effect of soy peptide on cognitive function
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of soy peptide on cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of correct answers on neuropsychological tests
Subjective mood states
Key secondary outcomes
Salivary parameter
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Low dose soy peptide containing powder 10g, 2 weeks
Interventions/Control_2
Middle dose soy peptide containing powder 10g, 2 weeks
Interventions/Control_3
Dextrin containing powder (Placebo) 10g, 2 weeks
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
| 60 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
1)More than 60 years and less than 70 years old.
2)Right-handed healthy Japanese.
Key exclusion criteria
1)Patient with Alzhheimer's desease
2)Patient with food, drug, and/or specifically soy allergy
3)Patient who had treatment, hospitalization, and/or surgery due to Stroke, Subarachnoid hemorrhage, Cerebral infarction, Cerebral hemorrhage, Brain contusion, and/or Head trauma
4)Patient who ingested in excessive alcohol
5)Patient with chronic or acute infection
6)Patient who has current disease or history of hepatitis
7)Patient with dementia
8)Patient who are attending a hospital by following diseases or has medical history of Attack, Seizures, Diabetes, Thyroid dysfunction, Blood dialysis, Uremia, Anuria, Inner ear disease (Meniere's disease and so on), and/or Asthma
9)Patient with medical history of serious disorder (Liver disease, Kidney disease, Hypertension, Ischemic heart disease, Impaired glucose tolerance and so on)
10)Patient who has received the neuropsychological tests in hospital
11)Patient with movement disorders, visual impairment, hearing impairment
12)Patient who has experience to feel sick by watching shiny light
13)Patient on a diet
14)Patient with excessive smoking habit
15)Patient who has habitual intake of pharmaceuticals and foods (general food, dietary supplement, functional food, health food, food for health claims, beverage, confectionary and so on) which may affect test results
16)Patient participating in other clinical trials at the start of the present study
17)Patient who the investigator deems inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal Medicine
Zip code
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-6135-5200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Terashima |
Organization
Oneness support Co., Ltd.
Division name
Clinical trial Division
Zip code
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, 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
Fuji Oil Holdings Inc.
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
Address
Tel
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
医療法人花音会みうらクリニック（大阪府） Miura Clinic, Medical Corporation Kanonkai（Osaka）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 30 | 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
| 2017 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 30 | Day |
Last modified on
| 2018 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030743
