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
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
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
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
