UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033910
Receipt number 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 09:33:53

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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 or person

Institute

HUMA R&D CORP

Institute

Department

Personal name



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

Value
https://center6.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