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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033910
Receipt No. R000038631
Scientific Title Investigation of the effect of ingestion of test foods on cognitive function
Date of disclosure of the study information 2018/08/27
Last modified on 2019/01/17

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Basic information
Public title Investigation of the effect of ingestion of test foods on cognitive function
Acronym Investigation of the effect of ingestion of test foods on cognitive function
Scientific Title Investigation of the effect of ingestion of test foods on cognitive function
Scientific Title:Acronym Investigation of the effect of ingestion of test foods on cognitive function
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate the effects of continued consumption of test foods on cognitive function in healthy Japanese men and women aged 40 to 65 years.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitrax
Key secondary outcomes MMSE,Subjective symptom questionnaire,IGF-1

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 4-week intake of the test food
Interventions/Control_2 4-week 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
40 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Japanese males and females aged 40 to 65 years at the time of informed consent
2)Persons who are aware of cognitive decline
3)Patients who can consume the test food continuously every day for 4 weeks.
4)Persons with MMSE scores of 24 or higher
5)A person who has received sufficient explanation on the purpose and content of the research, who has the ability to give consent, who voluntarily volunteers to participate in the research with a good understanding, and who has given written consent to participate in the research.
Key exclusion criteria 1)A person who is currently receiving any drug treatment or ambulatory treatment.
2)A person who is currently engaged in exercise or diet therapy under the supervision of a physician.
3)Persons with a history or present disease or complication of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic diseases
4)Persons with a history of drug or food allergy
5)Persons who wish to do so during pregnancy, lactation, or the study period
6)Persons with serious brain disease or a history
7)Persons who have received blood donations or vaccinations within the last 3 months or who may receive them during the study period.
8)Persons who routinely consume health foods, supplements, and pharmaceuticals that affect cognitive function
9)Persons with psychiatric disorder (depression, etc.) or sleep disorder, etc. who have visited the hospital or have previously visited the psychiatric department.
10)Alcohol-dependent, drug-dependent, or drug-abused persons who are being treated or have a history of such treatment
11)Persons who work on a shift basis, such as those who work at night
12)Those who eat extremely biased meals
13)Persons with extremely irregular lifestyle habits such as diet and sleep
14)Individuals who have participated in other clinical trials (studies) within 3 months from the date of informed consent, or who plan to participate in other clinical trials (studies) during the course of this study
15)Persons with difficulties in observing records on various questionnaires
16)Other persons who are judged by the investigator to be inappropriate for the study.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamatsu Atsushi
Organization Pharma Foods International Co., Ltd.
Division name Development Department
Zip code
Address 1-49 Goryo-Ohara, Nishikyo-ku, Kyoto 615-8245, Japan
TEL 075-394-8605
Email jim@medipharma.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Homepage URL
Email ochitani@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Pharma Foods International Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 27 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
2018 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 09 Day
Last follow-up date
2018 Year 11 Month 12 Day
Date of closure to data entry
2018 Year 11 Month 16 Day
Date trial data considered complete
2018 Year 12 Month 06 Day
Date analysis concluded
2019 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 27 Day
Last modified on
2019 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038631

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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