NCT05569044招募中不适用
Effects of Oral Rehydration Solutions in Healthy Adult Athletes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Anaerobic Power
研究概览
简要总结
This is a prospective, randomized, controlled, crossover study to determine the benefits of adult athletes consuming an oral rehydration solution (ORS) with exercise.
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 30 years of age.
- •Body fat percentage ≤17% for males and ≤24% for females.
- •Male or non-pregnant, non-lactating female, at least 6 months postpartum prior to screening visit.
- •Cycling VO2max in range of 45-53 mL O2/kg/min for males or 36-43 mL O2/kg/min for females.
- •If female, participant has a regular menstrual cycle, >21 days and <35 days in length.
- •Willing to consume grape-flavored beverages during the study.
- •If on chronic medication such as lipid-lowering, thyroid medication or hormone therapy, the dosage must be constant for at least 2 months prior to screening and baseline visit.
- •Weight-stable for the two months prior to screening visit
- •Voluntarily signed and dated an informed consent form (ICF), approved by an IRB, and provided Health Insurance Portability and Accountability Act (HIPAA) or other applicable privacy regulation authorization prior to any participation in the study.
- •No known intolerance or allergy to ingredients in study products.
- •Willing to refrain from using saunas or hot tubs for the duration of the study.
- •Willing to follow study procedures and complete any forms or assessments needed during the study.
排除标准
- •Athlete in a weight-conscious sport such as but not limited to wrestling, powerlifting, boxing, rowing, gymnastics or any martial arts.
- •Currently, and for the past 4 weeks or longer: running >40 miles per week on average, cycling >80 miles per week on average or swimming >20,000 yards per week on average.
- •Participating in another study that has not been approved as a concomitant study.
- •Uses any form of tobacco or nicotine, or other controlled substance not prescribed by a physician.
- •Previous history with heat illness or injury that resulted in a visit to a medical center.
- •Experienced a serious musculoskeletal injury or surgery in the past 6 months that poses a risk during the trial, according to the study investigator.
- •Eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures.
- •Currently taking or has taken antibiotics within 6 weeks of enrollment.
- •Currently taking or has taken a diuretic within 1 week of enrollment.
- •Diagnosed with the following according to medical records, self-report or according to the clinician's judgment:
- •Acute or chronic infections including but not restricted to respiratory infections, diarrhea, Hepatitis B or C, HIV infection or tuberculosis
- •Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
- •Cardiovascular, metabolic [including diabetes], renal, hepatic, or respiratory disease
- •Active malignancy
- •Polycystic ovary disease
- •Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
结局指标
主要结局
Anaerobic Power
时间窗: Through Study completion, an average of 6 weeks
Change in cycling power
次要结局
- Body Mass(Through Study completion, an average of 6 weeks)
- Muscular Force(Through Study completion, an average of 6 weeks)
- Rating of Perceived Exertion (RPE)(Through Study completion, an average of 6 weeks)
- Power Output(Through Study completion, an average of 6 weeks)
- Leg Strength(Through Study completion, an average of 6 weeks)
研究者
研究点 (2)
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