DGB-01 Effects on Endurance Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- The efficacy of DGB-01 in promoting exercise endurance will be measured by cycling performance on a standardized 40-km time trial course.
研究概览
简要总结
The purpose of this research is to evaluate the effects of DGB-01 on performance of a 40-km time trial in trained male cyclists. The investigators believe that DGB-01 will improve performance on the time trial as measured by a reduction in the amount of time required to complete the distance, using a computerized cycle ergometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males who are trained cyclists with a maximal oxygen uptake relative to body weight equal to or greater than 45 ml O2/kg/min.
- •Subjects must be in the competitive phase of their annual training cycle.
- •Between ages of 18-60
- •Availability- commitment of the subject/expected participation in the study for 97 days.
排除标准
- •Specific allergy to milk proteins (this is different from lactose intolerance)
- •Use of immunosuppressive medication in the case of organ transplants
- •Planned surgeries.
- •Kidney disorders
- •Use of antihypertensive medications
- •Cardiovascular disease
- •Abnormal BUN, creatinine, hemoglobin, or hematocrit
- •Body weight greater than 285 pounds
- •A protein-restricted diet
- •Subjects currently using dry whey protein supplements, N-acetylcysteine, or alpha-lipoic acid supplements. The wash-out period is 1 month for any of these supplements.
- •All medications that can interfere with muscle mass such as corticosteroids (e.g. prednisone), testosterone replacement or anabolic drugs such as Megace
研究组 & 干预措施
DGB-01
All subjects will receive DGB-01 during the study. Approximately one-half of the subjects during the first period and the other half during the second period.
干预措施: DGB-01 Supplementation (Dietary Supplement)
结局指标
主要结局
The efficacy of DGB-01 in promoting exercise endurance will be measured by cycling performance on a standardized 40-km time trial course.
时间窗: Individual participants will be followed for the duration of study enrollment, an expected average of 97 days. The study will remain open for up to 2 years or until subject number requirement is met.
Time to complete the 40km time trial for subjects with DGB-01 intervention in period 1 (minimum 4 weeks of supplementation) versus the time for time trial completion of these subjects with casein in period 2 (minimum of 4 weeks of supplementation); Between the two periods with supplementation, there will be a washout period of a minimum 4 weeks; Results of time trial for subjects with DGB-01 intervention in period 2 (minimum 4 weeks of supplementation) versus the time trial completion of these subjects with casein in period 1 (minimum 4 weeks supplementation).
次要结局
- Change in markers of plasma thiol status over the course of each time trial(Individual participants will be followed for the duration of study enrollment, an expected average of 97 days. The study will remain open for up to 2 years or until subject number requirement is met.)
- Outcome from specific questionnaires(Individual participants will be followed for the duration of study enrollment, an expected average of 97 days. The study will remain open for up to 2 years or until subject number requirement is met.)
研究者
William Black
Sponsor/Investigator
University of Kentucky