Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059086) titled 'Evaluation of the Effects of Fungal-Derived Ingredients on Immune Function and Physical Condition' on Sept. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Medical Corporation Hokubukai Utsukushigaoka Hospital
Condition:
Condition - Healthy Japanese adult
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Consumption of test food once a day for 4 weeks
Interventions/Control_2 - Consumption of placebo once a day for 4 weeks
Eligibility:
Age-lower limit - 18
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 2025, and who do not plan to receive new vaccinations after consent is obtained until the end of the study.
4) Individuals who have not been infected with an infectious disease (influenza or novel coronavirus) in the past year
5) 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 Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 04 Day
Date of IRB - 2025 Year 09 Month 11 Day
Anticipated trial start date - 2025 Year 09 Month 15 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067580
Disclaimer: Curated by HT Syndication.
