Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062316) titled 'Study of Postprandial Physiological State Assessment Using a Smart Ring' on Aug. 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - National Institute of Advanced Industrial Science and Technology (AIST)

Condition: Condition - N/A Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to quantify autonomic nervous system responses to a postprandial challenge using photoplethysmography (PPG)-derived indices obtained from a wearable device and to evaluate their validity. Heart rate variability indices will be used as the primary outcome measures to assess changes from the preprandial resting state to the postprandial period. In addition, postprandial hemodynamic responses, including changes in blood pressure, and metabolic responses will be assessed as reference measures for the integrated interpretation of physiological responses. For this purpose, glucose measurements obtained by self-monitoring of capillary blood glucose and glucose dynamics measured by continuous glucose monitoring (CGM) will be collected to the minimum extent necessary, and their associations with wearable device-derived indices will be examined as secondary outcomes. The findings will clarify the extent to which information obtained from a smart ring reflects changes in physiological state and will contribute to the research and development of physiological state assessment technologies using wearable devices. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 180 g jelly beverage containing 45 g of carbohydrate Interventions/Control_2 - 180 g jelly beverage containing 22.5 g of carbohydrate

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Adults aged 18 to <65 years Provision of written informed consent Ability and willingness to perform self-monitoring of capillary blood glucose by finger-stick sampling Key exclusion criteria - Hypertension Diabetes mellitus Cardiovascular disease Neurological disease Pregnancy Current use of medications that may affect cardiovascular function Gastrointestinal disease History of gastrointestinal surgery Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 27 Day Date of IRB - 2026 Year 07 Month 21 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2027 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071314

Disclaimer: Curated by HT Syndication.