UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049706 |
|---|---|
| Receipt number | R000056618 |
| Scientific Title | Evaluation of the effects of intake of fungus-derived ingredients on immunity and physical condition |
| Date of disclosure of the study information | 2023/12/05 |
| Last modified on | 2022/12/06 17:40:11 |
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Basic information
Public title
Evaluation of the effects of intake of fungus-derived ingredients on immunity and physical condition
Acronym
Evaluation of the effects of intake of fungus-derived ingredients on immunity and physical condition
Scientific Title
Evaluation of the effects of intake of fungus-derived ingredients on immunity and physical condition
Scientific Title:Acronym
Evaluation of the effects of intake of fungus-derived ingredients on immunity and physical condition
Region
| Japan |
Condition
Condition
Healthy Japanese adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This aim of this study is to confirm effect on immune function and the physical condition of food test food effect continuous consumption of test food by comparison with control food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dendritic cells activity
Key secondary outcomes
s-IgA, IgA, NK cell activity, neutrophil phagocytosis, antibody titer, questionnaire, Conditioning questionnaire, Safety
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of test food once a day for 12 weeks
Interventions/Control_2
Consumption of placebo once a day for 12 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females aged 18 to 69 years old when consent acquisition.
2) Subjects who feel catch colds easily and have caught a cold in the past 3 years.
3) Subjects who have not been vaccinated since June 2022, and who do not plan to receive new vaccinations after consent is obtained until the end of the study.
4) Subjects who have understood the purpose and contents of the study and agree to participate by signing the written informed consent.
Key exclusion criteria
1) Subjects using medical products.
2) Subjects who under treatment or with history of erious diabetes, kidney damage, hepatopathy and heart disease, hyroid disease, adrenal disease and other metabolic diseases.
3) Subjects who have a history of gastrointestinal disease (excluding a history of cecum).
4) Subjects who routinely take supplements that enhance immune function (agaricus, cordyceps, ericaceus, reishi mushroom, sparassis crispa, fucoidan, propolis, and lactic acid bacteria that promote the effectiveness of immune dunction).
5) Subjects who have chronic diseases and regularly use medicines.
6) Subjects who may have allergic symptoms to test foods, and subjects who may have allergic symptoms to other foods and medicines.
7) Subjects who routinely take steroids that may affect test results.
8) Subjects donated 200mL of blood in the past month or more than 400mL within 3 months.
9) Subjects with serious anemia.
10) Subjects who have tested positive for infectious disease (Syphilis, hepatitis B).
11) Subjects who have a history of drug dependence or alcohol dependence, or those who have a history of current illness.
12) Subjects who with eating disorders.
13) Subjects who take an amount of alcohol over 60g/day.
14) Subjects with possible changes of life style during the clinical studies.
15) Subjects who intend to become pregnant or lactating.
16) Subjects who participated in other clinical studied in the past 3 month.
17) Subjects judged as unsuitable for the study by the investigator for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Matsui |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Research and development Dept. Central R&D Laboratory
Zip code
567-0057
Address
1-30-3, Toyokawa. Ibaraki, Osaka, Japan
TEL
072-640-0121
y.matsui@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Matsuda |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
Homepage URL
matsuda@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical 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
Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel
011-881-0111
matsuda@ughp-cpc.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
| 2023 | Year | 12 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 06 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056618
