Tokyo, Jan. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060364) titled 'Study on the anti-allergic effects of a test substance' on Jan. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Yaizu Suisankagaku Industry Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the anti-allergic effects of test compounds ingestion.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Ingestion 0mg of test compounds for 12 weeks.
Interventions/Control_2 - Ingestion 5mg of test compounds for 12 weeks.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1.Males and females aged 20 to 64 years old
2.Subjects who can make self-judgment and are voluntarily giving written informed consent
3.Subjects who are aware of allergic symptoms or have been diagnosed with an allergy
Key exclusion criteria - 1.Subjects who have shrimp and/or crab allergy
2.Subjects who are under treatment or have a history of disease such as serious cardiovascular disease and digestive system disease
3.Subjects who continuously use functional foods claimed the anti-allergic effects (e.g., methylated catechins, plant-derived lactic acid bacteria K-2, or Lactobacillus strain L-92).
4.Subjects who are judged as unsuitable for the study by the test administrator for other reasons
Target Size - 24
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 29 Day
Date of IRB - 2025 Year 11 Month 28 Day
Anticipated trial start date - 2026 Year 01 Month 05 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069044
Disclaimer: Curated by HT Syndication.
