Tokyo, Sept. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063042) titled 'Effects of Combined Caffeine Mouth Rinse and Nasal Spray on Simulated 10-km Cycling and Stroop Outcomes' on Sept. 24.

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, physically active adult men Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine cycling and cognitive responses and early changes in plasma caffeine concentration following combined caffeine mouth rinse and nasal spray administration compared with matched placebo in physically active men. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Combined caffeine condition: Participants received the combined caffeine intervention twice: during the second minute of the 80-W cycling warm-up and at 5 km of the simulated 10-km cycling test. At each administration, caffeine nasal spray (20 mg/mL) was delivered as two 0.2-mL actuations into each nostril, providing a total volume of 0.8 mL and approximately 16 mg of caffeine. Immediately afterwards, participants rinsed 25 mL of caffeine solution (20 mg/mL; 500 mg caffeine) around the mouth for 5 s, followed by a 5-s oral-clearing period, and expectorated the solution as completely as possible. The mouth-rinse quantity represents oral exposure rather than an ingested dose. Interventions/Control_2 - Combined placebo condition: Participants received the placebo intervention at the same two timepoints and using the same administration procedures. At each administration, placebo nasal spray consisting of distilled water was delivered as two 0.2-mL actuations into each nostril, providing a total volume of 0.8 mL. Participants then rinsed 25 mL of placebo solution containing distilled water and sugar-free orange beverage, without caffeine, around the mouth for 5 s, followed by a 5-s oral-clearing period, and expectorated the solution as completely as possible.

Eligibility: Age-lower limit - 18 years-old

Gender - Male Key inclusion criteria - Physically active males. Previous experience performing exercise in a fasted state. Provided written informed consent to participate. Key exclusion criteria - Chronic metabolic or cardiovascular disease. Nasal pathology. Current smoking. Recent musculoskeletal injury. Habitual caffeine intake greater than 300 mg/day. Use of supplements or medications that could influence exercise or cognitive function. Target Size - 16

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 10 Month 06 Day Last follow-up date - 2026 Year 01 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072167

Disclaimer: Curated by HT Syndication.