NCT02255201已完成不适用
A Randomized, Double-Blind, Crossover Clinical Trial Comparing the Effects of Four Pre-Workout Beverages on Muscular Strength and Endurance and Cognitive Performance in Healthy Adult Males
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Muscular Strength and Endurance compared to Placebo
研究概览
简要总结
The purpose of this study is to determine the effects of four different pre-workout beverages as compared to placebo on muscular strength and endurance, perceived energy and cognitive performance in healthy adult males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males, aged 18 to 40 years
- •Subject has a waist circumference ≤ 97 cm.
- •Subject is a non-smoker.
- •Subject is in good health and appropriate for exercise as determined by physical examination, medical history and ECG.
- •Subject is weight training for the 6 months prior to starting the trial.
- •Subject agrees to not use any new vitamins and/or minerals until after study completion and to not take any vitamins and/or minerals 24 hours prior to the test visits.
- •Subject agrees to not use any dietary or herbal supplements until after study completion. A 7-day washout is allowed for study inclusion.
- •Subject is willing and able to comply with the protocol including:
- •Attending 5 visits each of which is approximately 4 hours long;
- •Refraining from caffeine, over-the-counter medications and alcohol for the 24 hours prior to the test visits;
- •Refraining from weight training for the 48 hours prior and refraining from any exercise other than weight training for 24 hours prior to the test visits;
- •Refraining from taking any dietary or herbal supplements throughout the study.
- •Subject is able to understand and sign the informed consent to participate in the study.
排除标准
- •Subject has any of the following medical conditions:
- •active heart disease
- •uncontrolled high blood pressure (≥ 140/90 mmHg)
- •renal or hepatic impairment/disease
- •Type I or II diabetes
- •bipolar disorder
- •pulmonary disease (including current asthma)
- •Parkinson's disease
- •Seizure disorder
- •unstable thyroid disease
- •immune disorder (such as HIV/AIDS)
- •active psychiatric disorders (including anxiety disorders)
- •bleeding disorders
- •gastrointestinal ulcer disease
- •any medical condition deemed exclusionary by the Principal Investigator (PI)
- •Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies) which make(s) resistance weight training contraindicated.
- •Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
- •No prescription or chronic medication use allowed without PI discretion.
- •Subject is currently taking and unwilling to refrain from taking any over-the-counter stimulant medications/supplements (see section 2.6.2); seven-day washout required for study inclusion.
- •Subject is currently taking and unwilling to refrain from taking any over-the-counter allergy or asthma medication containing pseudoephedrine or ephedrine (see section 2.6.2); seven-day washout required for study inclusion.
- •Subject has an allergy to milk and phenylalanine, or any of the ingredients in the test product (see section 3.2.1).
- •Subject reports sensitivity to caffeine and/or beta-alanine.
- •Subject reports being a regular caffeine consumer defined as consuming > 600 mg of caffeine per day.
- •Subject exhibits evidence of hepatic or renal dysfunction as evidenced by ALT, AST, AP being ≥ two times the upper limit of normal or serum creatinine value ≥ 2.0 mg/dl or other clinically significant abnormal clinical laboratory value per PI discretion.
- •Subject has a clinically relevant abnormality as defined by the PI or interpreting physician with respect to the ECG.
- •Subject has a QTcB interval > 450 msec.
- •Subject has a history of drug or alcohol abuse in the past 12 months.
- •Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
- •Subject has taken an investigational product within 30 days of the first exercise test visit (visit 2).
研究组 & 干预措施
Beverage A
Active Comparator
Single dose, Pre-Workout Master Performance Blend Dose 1
干预措施: Master Performance Blend Dose 1 (Dietary Supplement)
Beverage B
Active Comparator
Single dose, Pre-Workout Master Performance Blend Dose 2
干预措施: Master Performance Blend Dose 2 (Dietary Supplement)
Beverage C
Active Comparator
Single dose, Pre-Workout Performance Energy Blend
干预措施: Performance Energy Blend (Dietary Supplement)
Beverage D
Active Comparator
Single dose, Pre-Workout Energy Blend
干预措施: Energy Blend (Dietary Supplement)
Beverage E
Placebo Comparator
Single dose, Pre-Workout Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Muscular Strength and Endurance compared to Placebo
时间窗: One day
Muscular Strength and Endurance will be measured by Bench Press and Leg Press 1-RM and repetitions to exhaustion.
次要结局
- Change from Baseline in Cognitive Performance(Baseline to one-hour post dose and immediately post exercise)
研究者
研究点 (1)
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