UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052888 |
|---|---|
| Receipt number | R000060293 |
| Scientific Title | Functional food AHCC(R) helps support and regulate body functions |
| Date of disclosure of the study information | 2023/11/24 |
| Last modified on | 2023/11/24 12:32:20 |
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Basic information
Public title
Functional food AHCC(R) helps support and regulate body functions
Acronym
Functional food AHCC(R) helps support and regulate body functions
Scientific Title
Functional food AHCC(R) helps support and regulate body functions
Scientific Title:Acronym
Functional food AHCC(R) helps support and regulate body functions
Region
| Japan |
Condition
Condition
non-handicapped person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The term "pre-symptomatic" refers to the state of "fluctuation" between health and disease. Japan's "Strategy for Health and Medical Care" defines "pre-symptomatic state. "1 As Japan enters a super-aged society, preventive medicine must be established from the two main perspectives of extending healthy life expectancy and reducing medical and nursing care costs in order to realize healthy lives for people, and the need for measures to combat pre-symptomatic states is being called for. The establishment of preventive medicine is required from the two main perspectives of extending healthy life expectancy and reducing medical and nursing care costs. At the same time, however, challenges remain. In some cases, pre-symptomatic diseases have no subjective symptoms, and therefore, people often overlook their own ailments. Since no clear criteria or specific interventions have yet been established for pre-symptomatic diseases, we will explore the possibility of functional foods contributing to the treatment of pre-symptomatic diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparative quantitative values of identified proteins resulting from proteome analysis
Key secondary outcomes
Saliva sIgA
LF/HF (autonomic nervous activity)
Questionnaires
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Study subjects who meet the selection criteria and agree to participate in this study will receive the test food (28-day supply) and continue to consume the prescribed dosage daily during the intake period.
A) Test food: Functional food AHCC(R) (savory aroma and a taste that is mainly sour with a mixture of sweet, salty and bitter tastes)
B) Dosage of intake: 3 g per day (1 g in the morning, 1 g at lunch and 1 g in the evening, for a total of 3 g per day)
C) Method of intake: Oral intake after meals.
In addition to intake with water or lukewarm water, it may be taken with other foods such as miso soup, soup, yogurt or ice cream.
D) Period of intake: 28 days
E) Method of delivery: 28-day supply at the time of registration.
Interventions/Control_2
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
| 50 | years-old | < |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
- Male applicants must be between 50 and 59 years of age at the time of consent.
- Persons in good health.
- Persons who have received a thorough explanation of the study and who have given written consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
-Persons with severe food allergies
-Persons with severe chronic kidney disease
-Persons suffering from autoimmune diseases
-Persons under medical treatment, medication, or lifestyle guidance for schizophrenia, depression, mania, neurological disorders, or sleep disorders.
-Persons with other serious illnesses.
-Persons who have been taking functional foods derived from mushrooms (edible) or basidiomycetes (excluding multivitamin supplements) for at least one -month prior to the start of the study.
-Persons who are allergic to functional foods derived from mushrooms (edible) or basidiomycetes.
-Persons who are allergic to functional foods derived from mushrooms (edible) or basidiomycetes.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Takanari |
Organization
Amino Up Co., Ltd.
Division name
Business Development Division Academic Affairs
Zip code
004-0839
Address
363-32 Shinei, Kiyota, Sapporo, Hokkaido, JAPAN
TEL
011-889-2555
takanari@aminoup.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Shio |
Organization
Amino Up Co., Ltd.
Division name
Business Development Division Academic Affairs
Zip code
004-0839
Address
363-32 Shinei, Kiyota, Sapporo, Hokkaido, JAPAN
TEL
011-889-2555
Homepage URL
shio@aminoup.jp
Sponsor or person
Institute
Amino Up Co., Ltd.
Institute
Department
Personal name
Takuma Shio
Funding Source
Organization
Noastech Foundation, Inc.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
MIRUWS Co.,Ltd.
Name of secondary funder(s)
Amino Up Co., Ltd.
IRB Contact (For public release)
Organization
NPO corporation Hokkaido activation center TACTICS Ethics Committee
Address
5F, Infas, Kita 2-jo Nishi 9-chome, Chuo-ku, Sapporo, Hokkaido 060-0002, Japan
Tel
011-662-8591
yuriko.iw@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2023173
Org. issuing International ID_1
NPO corporation Hokkaido activation center TACTICS Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 24 | 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
| 2024 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
50s male, healthy subject, unwell (with indeterminate complaints)
Participant flow
Day0
Explanation of the study and obtaining consent
Fill out questionnaires (1) Subject background questionnaire, (2) Questionnaire on physical and mental status (VAS)
Blood sampling and saliva collection
Pulse wave information acquisition by wearable device
Daily intake of the test food for 28 days thereafter
Day14
Blood sampling, saliva collection
Fill in the questionnaire: Questionnaire on physical and mental condition (VAS)
Day 28
Blood and saliva sampling
Filling out the questionnaire: Questionnaire on physical and mental condition (VAS)
Acquisition of pulse wave information by wearable device
Adverse events
In case of any problem, contact the person in charge and keep a record of the incident.
Outcome measures
- Subject background: gender, age, occupation, height, weight, medical history, disease status, smoking, alcohol consumption, supplement intake, and lifestyle.
- Genetic testing (saliva collection)
- Proteome analysis (blood collection: 5 mL of blood (3 times, total blood volume 15 mL))
- Saliva sIgA (saliva collection)
- Autonomic nerve activity (wearable device for 3 days)
- Questionnaire (VAS)
- Adverse events
- Adherence to AHCC(R) intake: check the status of intake based on the number of remaining
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060293
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