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临床试验/NCT07658820
NCT07658820尚未招募不适用

The Role of Carbohydrate Blends and Electrolytes on Physical and Mental Performance During Cycling in the Heat

Arizona State University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2026年6月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
14
试验地点
1

研究概览

简要总结

The aim of the present study is to evaluate the effectiveness of a milk permeate-based sports drink on hydration, carbohydrate oxidation, exercise performance, vigilance, and reaction time in the heat. We anticipate that the milk permeate, with 44 g per liter and high sodium and potassium, will lead to better hydration, energy delivery, and physical and cognitive performance.

详细描述

EXPERIMENTAL PROTOCOL Each subject will complete five trials (one familiarization and four experimental), consisting of computer-based vigilance and reaction time tests (VIG/RT) administered before and after approximately 2 hours of cycling in a warm environment (90°F, 25-35% relative humidity). Each trial will be identical, with the only difference being the type of drink consumed during each trial. The beverages are commercially available products and are not considered investigational products under FDA regulations.

The first trial will be a familiarization trial, during which participants will complete the VIG/RT tests and cycling protocol exactly as performed in the experimental trials, but no biological samples will be collected. The remaining trials will be completed in randomized order, and the drink consumed will be:

A) Placebo (flavored water) B) GoodSport® (milk-permeate, lactose-free sports drink) C) Gatorade® (traditional sports drink) D) Low-Carb GoodSport® During the experiments, core body temperature, heart rate, skin temperature, urine samples, and expiratory gases will be collected. Blood samples will be collected using an intravenous catheter placed in an antecubital vein (see protocol figure on the next page). During the familiarization trial, no samples will be collected.

INFORMED CONSENT AND BASELINE ASSESSMENT During the initial visit, subjects will read the consent form, discuss any concerns, and have questions addressed. After signing the consent form, participants will have 20 minutes to complete the medical health history, PAR-Q questionnaire, and Ingestible Core Body Temperature Sensor Contraindication Form in person on paper.

If the volunteer is deemed eligible, height, weight, and body composition will be assessed on site using a bioelectrical impedance analyzer, and the procedure will take approximately five minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy and injury free (muscle, skeletal) for greater than 2 months
  • Active cyclists who train at least 3 times per week
  • Body mass index (BMI) range of 18.5-30 kg/m2
  • VO₂max ≥ 51 mL/kg/min for male participants
  • VO₂max ≥ 45 mL/kg/min for female participants

排除标准

  • Taking medicine influences the cardiovascular system
  • non-steroidal anti-inflammatory drugs during the last week
  • Cancer Diagnosis during the last 5 years
  • Current Pregnancy
  • History of renal disease, hypertension, obstructive gastrointestinal tract disease, disorders or impairment of the gag reflex, previous gastrointestinal surgery
  • History of heat stroke
  • Use of testosterone therapy
  • Adults who are unable to consent (impaired decision-making capacity)
  • Adults having Felinization of the esophagus
  • Adults who will undergo Nuclear Magnetic Resonance (NMR) or MRI scanning within 3 days of swallowing a temperature sensitive pills

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stavros Kavouras

Professor

Arizona State University

研究点 (1)

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