Clinical Trial: Acute effects of repeated caffeine nasal spray administration on cycling responses during simulated 10-km cycling, Stroop performance, and plasma caffeine concentrations (Japan)

Tokyo, Oct. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063196) titled 'Acute effects of repeated caffeine nasal spray administration on cycling responses during simulated 10-km cycling, Stroop performance, and plasma caffeine concentrations' on Oct. 6.

Study Type: Interventional

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

Primary Sponsor: Institute - Universiti Malaya

Condition: Condition - Healthy adult men, including physically active participants and moderately trained cyclists Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the acute effects of repeated caffeine nasal spray administration at 15 and 20 mg/mL, compared with placebo, on self-selected cadence and device-derived completion time during constant-power simulated 10-km cycling, Stroop performance, and plasma caffeine concentrations in healthy physically active men and trained cyclists. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Placebo condition: Participants received distilled water nasal spray during the second minute of the 80-W warm-up and at 25%, 50%, and 75% of the constant-power simulated 10-km cycling protocol. At each administration, two 0.2-mL actuations were delivered into each nostril, providing 0.8 mL per administration. The cumulative administered volume was 3.2 mL. This condition was completed once, with a 5-7-day washout period between trials. Interventions/Control_2 - 15 mg/mL caffeine nasal spray condition: Participants received caffeine nasal spray at 15 mg/mL during the second minute of the 80-W warm-up and at 25%, 50%, and 75% of the constant-power simulated 10-km cycling protocol. At each administration, two 0.2-mL actuations were delivered into each nostril, providing 12 mg of caffeine per administration and a cumulative dose of 48 mg. This condition was completed once, with a 5-7-day washout period between trials.

Eligibility: Age-lower limit - 18 years-old = Gender - Male Key inclusion criteria - Healthy men aged 18-35 years. Physically active participants or moderately trained cyclists. Habitually performed exercise in a fasted state. Able to complete the study procedures and provide written informed consent. Key exclusion criteria - Cardiometabolic disease. Nasal pathology. Current smoking. Recent musculoskeletal injury. Habitual caffeine intake greater than 300 mg/day. Use of supplements or medications likely to influence caffeine metabolism or the study outcomes. Target Size - 28

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 12 Month 19 Day Date of IRB - 2025 Year 02 Month 15 Day Anticipated trial start date - 2025 Year 02 Month 15 Day Last follow-up date - 2025 Year 09 Month 19 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072332

Disclaimer: Curated by HT Syndication.