Tokyo, June 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061913) titled 'Evaluative study on nutritional status estimation and specific health guidance program using urine tests and questionnaires' on June 20.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Toyoda Gosei Co., Ltd.
Condition:
Condition - To evaluatively assess the validity of a nutrient dietary intake estimation logic combining instant urine test data and questionnaire responses, and to exploratorily evaluate the efficacy of an individualized dietary guidance program utilizing the logic.
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Efficacy, Feasibility
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - During the 3-month study period, a total of 3 urine tests using the Yuurea app, dietary photo/weight/waist circumference recording on the eat+ app, 3 questionnaire responses, and a total of 3 individualized dietary guidance sessions by registered dietitians will be conducted.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Individuals who understand the purpose of this study and voluntarily consent to participate.
2. Employees of the research sponsor (including those eligible for specific health guidance) or general public participants aged 20 and over.
Key exclusion criteria - 1. Individuals taking diabetes medications (GLP-1 receptor agonists, insulin preparations, SGLT2 inhibitors, etc.).
2. Individuals taking antihypertensive drugs (ACE inhibitors, ARBs, diuretics, etc.).
3. Individuals with renal dysfunction or serious illness who are under dietary restrictions by a physician.
4. Individuals who find it difficult to operate smartphones, or who are expected to have difficulty continuing due to long-term business trips, etc.
Target Size - 130
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 10 Day
Date of IRB - 2026 Year 06 Month 10 Day
Anticipated trial start date - 2026 Year 06 Month 20 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=R000070844
Disclaimer: Curated by HT Syndication.