Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062859) titled 'A Study on the Effects of Continuous Intake of the Test Food on Immune Function' on Sept. 9.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Macromill Carenet, Inc.
Condition:
Condition - Healthy participants
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of 12-week continuous intake of the test food on immune function in healthy individuals who subjectively feel susceptible to catching colds through a randomized, double-blind, placebo-controlled, parallel-group study.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Test food group: Tablets containing lactic acid bacteria (1 tablet daily for 12 weeks)
Interventions/Control_2 - Placebo group: Placebo tablets (1 tablet daily for 12 weeks)
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - (1) Healthy Japanese male and female subjects aged 20 to 64 years at the time of providing informed consent.
(2) Participants who subjectively feel that they easily catch colds in daily life.
(3) Participants with relatively low salivary sIgA levels at the visit screening test.
(4) Participants who have received a thorough explanation of the purpose and content of the trial, possess the capacity to consent, fully understand the content, and can provide personal consent via electronic informed consent.
Key exclusion criteria - (1) Participants receiving medical treatment/medication for autoimmune/immunodeficiency diseases or allergic diseases, or planning to during the study.
(2) Participants regularly using immunosuppressants, steroids, antiallergics, antihistamines, or intestinal regulators.
(3) Participants with chronic diseases (e.g., diabetes, dyslipidemia, hypertension) receiving treatment/medication.
(4) Participants with a history of serious cerebrovascular, cardiac, hepatic, renal, hematological, or endocrine diseases.
(5) Participants with a history of serious gastrointestinal diseases (e.g., gastrectomy, bowel resection; excluding appendectomy).
(6) Participants at risk of allergic reactions to the test foods.
(7) Participants with significant abnormalities in screening tests (vital signs, physical examinations, or blood tests).
(8) Participants who experienced feeling unwell during past blood sampling.
(9) Participants who donated 200 mL blood within 4 weeks or component blood within 2 weeks; females who donated 400 mL within 16 weeks; males who donated 400 mL within 12 weeks.
(10) Participants who may develop pollinosis during the study period (Dec-Mar).
(11) Participants vaccinated within 4 weeks prior to screening, or unable to agree not to receive vaccines during the study.
(12) Participants with oral diseases with bleeding tendency that may contaminate saliva.
(13) Participants unable to stop intake of FOSHU, Foods with Function Claims, or supplements.
(14) Current smokers.
(15) Regular alcohol drinkers (approx. 60 g/day or more).
(16) Participants with extremely irregular sleep or dietary habits.
(17) Participants whose living environment, dietary, or exercise habits may change significantly.
(18) Pregnant, lactating, or planning to become pregnant females.
(19) Participants who are participating, have participated within the past 4 weeks, or are planning to participate in other clinical trials.
(20) Participants judged ineligible by the principal investigator.
Target Size - 112
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 09 Day
Date of IRB - 2026 Year 09 Month 09 Day
Anticipated trial start date - 2026 Year 10 Month 23 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071693
Disclaimer: Curated by HT Syndication.
