Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062691) titled 'Effects of Ingesting Electrolyte-Containing Food on Physiological Strain and Conditioning in the Heat: A Randomized, Double-Blind, Parallel-Group Trial' on Aug. 26.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Musashigaoka Junior College

Condition: Condition - Healthy volunteers under heat stress Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to investigate the effects of ingesting electrolyte-containing food in combination with fluid intake on core body temperature elevation, dehydration rate, and subjective conditioning during prolonged exercise in the heat. Through this randomized controlled trial, we evaluate effective nutritional supplementation strategies for reducing physiological strain and preventing heat-related disorders during physical activity under heat stress. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Ingestion of an electrolyte-containing food containing sodium, potassium, calcium, magnesium, and carbohydrates along with regular water intake at scheduled intervals during an exercise protocol under heat stress. Interventions/Control_2 - Ingestion of a placebo food (matched in appearance, flavor, and energy content to the active food, with electrolyte minerals replaced by carbohydrates) along with regular water intake at scheduled intervals during an exercise protocol under heat stress.

Eligibility: Age-lower limit - 18 years-old = Gender - Male Key inclusion criteria - Healthy adult males aged 18 years or older who have sufficient physical fitness and exercise experience to safely complete the specified exercise protocol in the heat, and who have provided voluntary informed consent after fully understanding the study protocol. Key exclusion criteria - Individuals with a history of cardiovascular, renal, or gastrointestinal diseases; a history of severe heat-related illness; known allergies to the test food ingredients; or those regularly taking medications that may affect metabolism, thermoregulation, or hydration status. Target Size - 24

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 03 Month 12 Day Date of IRB - 2026 Year 03 Month 19 Day Anticipated trial start date - 2026 Year 08 Month 27 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071777

Disclaimer: Curated by HT Syndication.