UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of soy peptide supplementation on cognitive function -A paralleled, randomized, double-blind, placebo-controlled dose response study-
Title of the study (Brief title)	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	Naoki Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal Medicine
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	Makoto Terashima
Organization	Oneness support Co., Ltd.
Division name	Clinical trial Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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