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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026779
Receipt No. 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

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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
Email 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
Email mterashima@oneness-sup.co.jp

Sponsor
Institute Miura Clinic, Medical Corporation Kanonkai
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030743

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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