Tokyo, Dec. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059993) titled 'A study for evaluating the effects of test food intake on immune function - single-arm open-label study-' on Dec. 5.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - APO PLUS STATION CO., LTD.
Condition:
Condition - Healthy volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate the impact of consuming the test food on immunological parameters over a 12 week period. In addition, the long-term safety of the test food will be assessed during the same timeframe.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Daily intake of test food over 12 weeks.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - (1) Healthy Japanese males and females aged 20 years or older but under 65 at the time of consent.
(2) Individuals who consider themselves prone to catching colds.
(3) Individuals who have had an acute upper respiratory tract infections within the past two years.
(4) Individuals who have health examination results from the past year and showing no findings that requiring treatment.
(5) Individuals who have received sufficient explanation about the study and signed the informed consent form prior to participation.
Key exclusion criteria - 1) Individuals with malignant tumors, heart failure, or myocardial infarction (current or past).
2) Individuals with current or past treatment for:
[1] Arrhythmia, liver dysfunction, renal impairment, cerebrovascular disease, thyroid disorders, gastrointestinal diseases, rheumatoid arthritis, diabetes, dyslipidemia, hypertension, or other chronic illnesses
[2] Bronchial asthma or chronic bronchitis
3) Individuals with drug or alcohol dependence (current or past).
4) Individuals with hay fever or allergic rhinitis.
5) Individuals with mental disorders, depressive symptoms, or under treatment for such conditions.
6) Individuals with food allergies or potential allergy to the test food.
7) Individuals regularly using prescription or quasi-drugs affecting study outcomes and unable to discontinue during the study.
8) Individuals regularly consuming health foods affecting study outcomes and unable to discontinue during the study.
9) Individuals consuming excessive alcohol.
10) Heavy smokers.
11) Individuals unable to abstain from alcohol and smoking from the day before each visit until the end of the examination.
12) Individuals unable to maintain usual lifestyle.
13) Individuals with extremely irregular habits (e.g., night shift workers).
14) Individuals scheduled for vaccination during the study.
15) Individuals planning overseas travel during the study.
16) Individuals who are pregnant, breastfeeding, or planning pregnancy during the study.
17) Individuals who participated in another clinical trial within 1 month prior to consent or plan to participate during the study.
18) Individuals deemed inappropriate by the principal investigator.
Target Size - 13
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 26 Day
Date of IRB - 2025 Year 12 Month 03 Day
Anticipated trial start date - 2025 Year 12 Month 07 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068559
Disclaimer: Curated by HT Syndication.
