Randomized, Double-blind, Placebo-controlled, Short Term Trial of DelivraTM Livsport Preworkout Cream With or Without Oral Creatine for Improved Power Output and Reduction of Muscle Fatigue During Resistant Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 6
- 主要终点
- Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
研究概览
简要总结
Creatine is a nutritional supplement that is often ingested to improve exercise performance. The advent of a new product that is applied to the skin overlying muscle offers potential benefit, if the creatine can be targeted to specific muscles. The investigators are testing a novel creatine cream to determine the effects on human muscular performance. The investigators are assessing whether 7 days of topical creatine application is additive to orally-ingested creatine for improving muscular power (determined by knee extension).
详细描述
Creatine monohydrate is a popular nutritional supplement with athletes involved in sports involving strength and power. When creatine is orally ingested it combines with inorganic phosphate to form phorylcreatine (PCr) in skeletal muscle . Adenosine Triphosphate (ATP) is the immediate source of energy in muscle - during exercise ATP is broken down to Adenosine Diphosphate (ADP) and inorganic phosphate. Duration of high-intensity exercise is limited to a few seconds based on limited ATP stores in muscle. PCr acts to re-phosphorylate ADP to form ATP so that muscle contraction can continue at high intensities. After creatine monohydrate is ingested, high-intensity exercise capacity is increased because of the increased PCr stores in muscle.
Traditionally, creatine is consumed orally as a supplement. Delivra Inc. has developed a topical cream containing creatine that is designed to penetrate the skin. The study purpose is to determine whether topically-applied creatine is additive with orally-ingested creatine for improving muscular strength and power.
The hypothesis is that topically-applied creatine is additive with orally-ingested creatine for improving muscular performance.
The study involves a double-blind placebo-controlled parallel group design. Participants (n=132) will be randomized to receive either oral creatine supplementation or placebo (21 g/d) for 7 days. One leg of each participant will be randomized to receive topical creatine (3.5 mL/d) and the opposite leg placebo for 7 days.
The baseline assessment involves measuring muscular power during 5 sets of 15 repetitions of knee extension on a dynamometer, with each set separated by 1 minute rest, with each leg tested separately. Additional measures include assessment of body composition and body water content. Participants will then receive either oral creatine (21 g/d) or placebo for 7 days. One leg of each participant will be randomized to receive topical creatine (3.5 mL/d) and the opposite leg placebo for 7 days. The same assessments as done at baseline will then be repeated after the 7 days of creatine supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physically active and able to pass Physical Activity Readiness Questionnaire
排除标准
- •Allergies to any ingredients in the cream
- •Answering "yes" to Physical Activity Readiness Questionnaire
- •Currently pregnant or breastfeeding,
- •Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (eg: cancer, immunosuppressed)
- •History of alcohol or drug abuse within the past year
- •Anyone using recreational drugs
- •Use of performance enhancing drugs or supplements within 2 months including caffeine and creatine in supplement form
- •Currently using other topical agents for treatment of pain or inflammation
研究组 & 干预措施
Oral creatine supplementation
21 g/d oral creatine for 7 days
干预措施: 3.5 mL/d topical creatine (Dietary Supplement)
Oral creatine supplementation
21 g/d oral creatine for 7 days
干预措施: 3.5 mL/d topical placebo (Dietary Supplement)
Oral creatine supplementation
21 g/d oral creatine for 7 days
干预措施: 21 g/d Oral creatine (Dietary Supplement)
Oral placebo supplementation
21 g/d oral placebo for 7 days
干预措施: 3.5 mL/d topical placebo (Dietary Supplement)
Oral placebo supplementation
21 g/d oral placebo for 7 days
干预措施: 21 g/d oral placebo (Dietary Supplement)
Oral placebo supplementation
21 g/d oral placebo for 7 days
干预措施: 3.5 mL/d topical creatine (Dietary Supplement)
结局指标
主要结局
Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
时间窗: Change from baseline to 7 days
次要结局
- Change in body composition (percent fat)(Change from baseline to 7 days)
- Change in body water content(Change from baseline to 7 days)
- Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer(Change from baseline to 7 days)
- Adverse events recorded on adverse event forms(Change from baseline to 7 days)
研究者
Phil Chilibeck
Professor
University of Saskatchewan