Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060237) titled 'Investigation of the taste and sodium excretion effect of alginate-containing bread' on Dec. 30.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Toy Medical Co., Ltd.
Condition:
Condition - Healthy adults, prevention of lifestyle-related diseases (prevention of hypertension)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the usefulness of alginate-containing bread in terms of "taste acceptability" and "physiological effects." The first trial evaluates taste, and the second trial exploratorily evaluates the effect on urinary sodium excretion after 5 days of continuous intake.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Continuous intake of alginate-containing bread (one piece) once a day for 5 days.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Employees working at the collaborating institution or the institution providing the research field
2. Individuals who understood the purpose of the study and expressed consent to participate by signing
Key exclusion criteria - Individuals with allergies to ingredients (wheat, milk, egg, seaweed, etc.)
Individuals undergoing treatment for kidney disease or receiving potassium restriction guidance from a physician
Pregnant or breastfeeding individuals
Others judged inappropriate by the principal investigator
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 30 Day
Date of IRB - 2025 Year 12 Month 30 Day
Anticipated trial start date - 2026 Year 01 Month 19 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068896
Disclaimer: Curated by HT Syndication.