Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance
- Conditions
- Athletic Performance
- Interventions
- Dietary Supplement: Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 SupplementDietary Supplement: Broad Spectrum Safety
- Registration Number
- NCT04121481
- Lead Sponsor
- Victory Nutrition International, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement Approximately a total of 75 participants will be assigned in the Placebo Group (two divided doses will be given) Treatment Group Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement Approximately a total of 75 participants will be assigned in the Treatment Group (two divided doses will be given) Adverse Event Monitoring will be Strictly Enforced Treatment Group Broad Spectrum Safety Approximately a total of 75 participants will be assigned in the Treatment Group (two divided doses will be given) Adverse Event Monitoring will be Strictly Enforced Placebo Broad Spectrum Safety Approximately a total of 75 participants will be assigned in the Placebo Group (two divided doses will be given)
- Primary Outcome Measures
Name Time Method Anthropometric Measurements: Waist-Hip Ratio Over a Period of 90-Consecutive Days Waist : Hip Ratio
Anthropometric Measurements: Body Weight Over a Period of 90-Consecutive Days Body Weight (Kilograms)
Anthropometric Measurements: Blood Pressure (mmHg) Over a Period of 90-Consecutive Days Blood Pressure (mmHg)
Body Composition and Bone Mineral Density: DEXA (GE) Over a Period of 90-Consecutive Days DEXA and Bone Mineral Density
Ergometric Assessment: Treadmill Over a Period of 90-Consecutive Days Ergometric measurements
Handgrip Dynamometer Over a Period of 90-Consecutive Days Handgrip strength
Respiration Quality and Rate: Spirometer Over a Period of 90-Consecutive Days Respiration Quality, VO2 and VCO2 assessments
Endurance Studies Over a Period of 90 Consecutive Days Cycle Ergometer, Bench Press and Leg Press
Anthropometric Measurements: Height Over a Period of 90-Consecutive Days Height (Meters)
Anthropometric Measurements: Waist Circumference Over a Period of 90-Consecutive Days Waist Circumference (Meters)
- Secondary Outcome Measures
Name Time Method Lipid Profile Over a Period of 90-Consecutive Days Complete Lipid Profile
Total Blood Chemistry Over a Period of 90-Consecutive Days Blood Chemistry
Trial Locations
- Locations (1)
Champions Sports Performance & Hardcore Serious Fitness
🇺🇸Cornelius, North Carolina, United States