UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the effect of ingestion of test foods on cognitive function
Title of the study (Brief title)	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	Yamatsu Atsushi
Organization	Pharma Foods International Co., Ltd.
Division name	Development Department
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	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 10 Day
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

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Publication of results	Unpublished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