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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048084
Receipt No. R000054792
Scientific Title Effects of test foods on cognitive function
Date of disclosure of the study information 2022/06/17
Last modified on 2022/06/17

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Basic information
Public title Effects of test foods on cognitive function
Acronym Effects of test foods on cognitive function
Scientific Title Effects of test foods on cognitive function
Scientific Title:Acronym Effects 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 To examine the effects of 12 weeks of continuous intake of test foods on cognitive function in a randomized, double-blind, placebo-controlled, parallel-group study. At the same time, we will confirm the safety of the test food.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BDNF,Cognitrax
Key secondary outcomes (Secondary outcomes)
Brain Health Check (expanded version), Pittsburgh Sleep Questionnaire
(Safety evaluation)
Vital signs, physical measurements (weight, BMI), blood biochemistry, hematology, urinalysis, adverse events

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 Prevention
Type of intervention
Food
Interventions/Control_1 Continuous intake of test foods 1 for 12 weeks
Interventions/Control_2 Continuous intake of test foods 2 for 12 weeks
Interventions/Control_3 Continuous intake of control foods for 12 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
50 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Japanese men and women aged between 50and 75 years old at the time of obtaining written consent.
2. Subject who is aware of cognitive decline.
3. Subject who has a MMSE-J score of 22 points or more.
4.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Key exclusion criteria 1.Subject who has been diagnosed with dementia by a physician.
2.Subject who is taking medication or under medical treatment due to serious illness.
3.Subject who is under exercise therapy or dietetic therapy.
4.Subject who is at risk of showing allergic symptoms to 28 food allergens (7 allergens (egg, milk, wheat, peanut, shrimp, buckwheat, crab) obligated and 21 allergens (kiwifruit, walnut, soybean, banana, yam, cashew nut, peach, sesame, mackerel, salmon, squid, chicken, apple, matsutake mushroom, orange, beef, gelatin, pork, abalone, salmon roe, almond) recommended for labeling)
5.Subject who has or had a history of either medicine or alcohol dependence syndrome.
6.Subject who are currently attends a hospital or has a history of mental disorder (depression, etc.) or sleep disorder (insomnia, sleep apnea syndrome, etc.)
7.Subject whose working hours are irregular due to night shifts, etc.
8.Subject who has extremely irregular lifestyle habits such as eating and sleeping.
9.Subject who has an extremely unbalanced diet.
10.Smoking more than 21 cigarettes/day or heavy alcohol drinkers (average net alcohol intake of about 60 g/day or more)
11.Subject with a serious current or previous illness such as brain disease, malignant tumor, immunological disease, diabetes, liver disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, or other metabolic disease.
12.Subject who takes supplements, health foods, etc. (including food for specified health uses and food with functional claims) or medicines that affect cognitive functions for 4 days or more per week.
13.Subjects who has a habit of taking products containing ingredients of test foods.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hidemasa
Middle name
Last name Toya
Organization HUMA R&D CORP
Division name Clinical Development Department
Zip code 108-0014
Address Round Cross Tamachi 9F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 03-3431-1260
Email toya@huma-rd.co.jp

Public contact
Name of contact person
1st name Hidemasa
Middle name
Last name Toya
Organization HUMA R&D CORP
Division name Clinical Development Department
Zip code 108-0014
Address Round Cross Tamachi 9F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 03-3431-1260
Homepage URL
Email toya@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Meiji Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committees of Yoga Allergy Clinic
Address 4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel 03-5491-4478
Email jim@medipharma.co.jp

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
2022 Year 06 Month 17 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 Preinitiation
Date of protocol fixation
2022 Year 06 Month 07 Day
Date of IRB
2022 Year 06 Month 10 Day
Anticipated trial start date
2022 Year 07 Month 19 Day
Last follow-up date
2022 Year 12 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (Exclusion criteria continued)
14.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
15.Subject who has blood collection or donation more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition.
16.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
17.Subject who has difficulty observing records on various survey forms.
18.Subject who is judged as an inappropriate candidate according to the screening data.
19.Subject who is considered as an inappropriate candidate by the doctor in charge.
20.Subject who is unable to cooperate with the countermeasures against SARS-CoV-2 infection and PCR testing as stipulated by the government and local authorities according to the status of SARS-CoV-2 infection.

Management information
Registered date
2022 Year 06 Month 17 Day
Last modified on
2022 Year 06 Month 17 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054792

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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