A Randomized, Double-blind, Placebo Controlled, Single-center Study to Determine the Effects of Pre-workout and Recovery Formulations on Soreness, Performance, Tolerance and Safety Outcomes in Healthy Adults Undergoing Training Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pharmanex
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Performance
研究概览
简要总结
The acute study will evaluate pre- and post-exercise ingestion of a multi-ingredient supplement in a randomized, double-blind, placebo-controlled, crossover design. Participants will complete one enrollment visit, in which they will sign a consent form and complete a health history questionnaire. Participants will complete two interventions, with three visits each (6 visits total), in which a treatment beverage (pre/post supplement, or non-caloric placebo) will be consumed within 30 minutes prior to exercise and within 15 minutes post-exercise, in random order. Total time from enrollment to completion will be at least 14 days. Testing visits will be separated by a minimum of 7 days of rest to allow for recovery and washout, based on a half-life of ≤8 hours for all ingredients present in the supplement.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is an adult between the ages of 25-50 years
- •Participant has a recorded BMI of 20-35 kg/m2
- •Participant exercises less than 3 hours per week for at least 8 weeks preceding the study
- •Participant has provided written and dated informed consent to participate in the study
- •Participant is willing to and able to comply with the protocol
- •Participant is apparently healthy and no reported metabolic disorders, heart disease, arrhythmias, thyroid disease, renal, hepatic, autoimmune or neurological diseases, as determined by a health history questionnaire
- •Participant agrees to maintain current diet and exercise routine during the study
- •Participant agrees to refrain from taking any anti-inflammatory supplement 48 hours prior to exercise (acute) or medications to prevent any further nutritional or drug related protection against exercise induced muscle damage
- •Participant has a resting (seated for 5 minutes) blood pressure of systolic pressure between 140-90 mmHg and a diastolic pressure between 90-50 mmHg
排除标准
- •Participant is currently enrolled in a separate clinical trial or weight loss program involving diet, exercise, physical activity, or the potential ingestion of an active drug or dietary supplement
- •Participant is using, or has consistently used one of the following dietary supplements within 12 weeks prior to enrollment: Beta-alanine, Creatine, HMB, Carnosine, Vitamin D
- •Participant has consistently consumed whey protein/plant protein and/or 1,000 mg of fish oil within the previous 4 weeks prior to enrollment
- •Participant has gained or lost ≥ 8 lbs in the previous month
- •Participant has a known allergy or sensitivity to the placebo or active ingredients
- •Participant has used tobacco more than three days per week (on average) in the previous 6 months, or refuses to abstain from all tobacco use for the duration of the study
- •Participant is pregnant or planning to become pregnant
- •Participant has any musculoskeletal condition prohibiting them from participation
结局指标
主要结局
Performance
时间窗: baseline, 24 hours, 48 hours
Change from baseline on performance by measuring countermovement vertical jump height using a jump mat and associated velocity using a linear transducer.
次要结局
- Muscle soreness(baseline, 24 hours, 48 hours)
- Creatine Kinase(baseline, 24 hours, 48 hours)
- Isoprostanes(baseline, 24 hours, 48 hours)