Tokyo, Jan. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060362) titled 'Monitoring test of salt offset jelly' on Jan. 15.
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
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluate the salt (sodium) absorption inhibitory effect (salt excretion effect) on adults aged 20 years or older by intake alginate-containing jelly for 2 weeks.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intake of alginate-containing jelly (containing 0.75 g of alginate) twice a day for 2 weeks.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2.Persons who are 20 years or older.
Key exclusion criteria - 1.Persons who have chronic illness, receiving medication, have a serious disease history.
2.Persons who are allergic to the test food.
3.Persons who usually take a large amount of test food.
4.Persons who usually take medicine and specified health food that may have effect to salt absorption or excretion.
5.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam.
6.Persons who were judged as inappropriate for study participants by the principal investigator.
7.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding.
Target Size - 150
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 14 Day
Date of IRB - 2026 Year 01 Month 14 Day
Anticipated trial start date - 2026 Year 01 Month 16 Day
Last follow-up date - 2026 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069056
Disclaimer: Curated by HT Syndication.