Tokyo, Feb. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060752) titled 'Effects of Nostoc commune hot-water extract intake on salivary IgA in healthy adults' on Feb. 28.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Kitasato University
Condition:
Condition - Healthy adults (mucosal immunity assessment)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to evaluate the effects of hot-water extract of edible cyanobacteria Nostoc commune on salivary secretory immunoglobulin A (sIgA) levels in healthy adults using a randomized crossover design. This study aims to assess mucosal immune responses and explore the potential of Nostoc commune as a functional food material.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants ingest 100mL of a beverage made by extracting 1g of Nostoc with 100mL of hot water. After an overnight fast, salivary samples are collected repeatedly up to 120 minutes post-intake. A 6-day washout period is applied before crossover to the control condition.
Interventions/Control_2 - Participants ingest 100 mL of water as the control beverage under identical conditions. Saliva is collected repeatedly under the same protocol, followed by crossover after a 6-day washout period.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Healthy adults aged 18 years or older
Students or staff at Kitasato University Sagamihara campus
Provided written informed consent
Key exclusion criteria - Allergy to Nostoc commune components
Fever 37.5 C or higher
Regular medication use
Immunodeficiency anticoagulant therapy or significant underlying disease
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 20 Day
Date of IRB - 2026 Year 02 Month 25 Day
Anticipated trial start date - 2026 Year 03 Month 01 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069476
Disclaimer: Curated by HT Syndication.