Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Anthropometric Measurements: Waist-Hip Ratio
研究概览
简要总结
This pilot investigation will conduct a randomized placebo-controlled, double-blind study in 150 volunteers (age: 18-74 years) over a period of 90 consecutive days. A statistician will be involved in this project. Body weight, body mass index (BMI), waist circumference, blood chemistry, blood pressure and heart rate, body and hand grip strength, speed and endurance studies including open circuit spirometry-based assessment of pulmonary function will be assessed. Other parameters to be evaluated include oxygen consumption, CO2 production and metabolic parameters, VO2 max, respiratory exchange ratio (RER), anaerobic threshold, ventilatory equivalents for oxygen (VE/V02) and exhaled carbon dioxide (VE/VC02)2,3. Subjects will participate in completed maximal graded exercise tests (GXT) on a treadmill or in set distance open-field sprints using open-circuit spirometry. Lower and Upper Body Strength will be evaluated. E-Diary will be provided to all participants. Survey Monkey program will be provided to all subjects and regularly updated by all study participants daily and endorsed by the co-Principal Investigator.
详细描述
A novel patented Prodovite® VMP35 Multi-Nutrient-Complex (MNC), a vitamin, mineral, and phytonutrient encapsulated liquid formulation, was prepared using a novel proprietary SK713 SLP multi-lamellar clustoidal non-GMO phospholipid Prodosome nutrient absorption/delivery technology in a state-of-the-art multistep cGMP and NSF-certified manufacturing facility. This developmental technology is biodegradable and biocompatible. Preliminary study in our laboratory demonstrated the efficacy of Prodovite® VMP35 in Sports Nutrition. We hypothesize that Prodovite® VMP35 supplement will enhance athletic performance, lean-body muscle mass, increase exercise tolerance, and improve anabolic parameters in healthy human subjects. The aim of this pilot study is to evaluate the effect of oral supplementation of Prodovite® VMP35 on exercise endurance, muscle strength, anabolic parameters and lean body mass in healthy human subjects. We hypothesize that Prodovite® VMP35 supplementation will enhance and increase exercise performance, tolerance, lean-body muscle mass, improve anabolic parameters and blood chemistry parameters in healthy human subjects. Accordingly, 150 healthy male and female subjects will be randomly assigned to receive either Prodovite® VMP35 or placebo in the form of single dose sealed containers for 90 consecutive days and muscle strength, endurance, speed, anabolic/catabolic parameters and muscle mass will be evaluated by dual energy X-ray absorptiometry (DEXA), hand-grip strength test, cycle ergometer test, spirometer assessment and assay of Blood chemistry and serum biomarkers will be evaluated before and after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Double-Blind Placebo-Controlled Study
入排标准
- 年龄范围
- 18 Years 至 74 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Anthropometric Measurements: Waist-Hip Ratio
时间窗: Over a Period of 90-Consecutive Days
Waist : Hip Ratio
Anthropometric Measurements: Body Weight
时间窗: Over a Period of 90-Consecutive Days
Body Weight (Kilograms)
Anthropometric Measurements: Blood Pressure (mmHg)
时间窗: Over a Period of 90-Consecutive Days
Blood Pressure (mmHg)
Body Composition and Bone Mineral Density: DEXA (GE)
时间窗: Over a Period of 90-Consecutive Days
DEXA and Bone Mineral Density
Ergometric Assessment: Treadmill
时间窗: Over a Period of 90-Consecutive Days
Ergometric measurements
Handgrip Dynamometer
时间窗: Over a Period of 90-Consecutive Days
Handgrip strength
Respiration Quality and Rate: Spirometer
时间窗: Over a Period of 90-Consecutive Days
Respiration Quality, VO2 and VCO2 assessments
Endurance Studies
时间窗: Over a Period of 90 Consecutive Days
Cycle Ergometer, Bench Press and Leg Press
Anthropometric Measurements: Waist Circumference
时间窗: Over a Period of 90-Consecutive Days
Waist Circumference (Meters)
Anthropometric Measurements: Height
时间窗: Over a Period of 90-Consecutive Days
Height (Meters)
次要结局
- Total Blood Chemistry(Over a Period of 90-Consecutive Days)
- Lipid Profile(Over a Period of 90-Consecutive Days)
