Efficacy Of Prodovite® In Athletic Performance

Study Overview
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Brief Summary
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A novel patent-pending Prodovite® VMP35 Multi-Nutrient-Complex (MNC), a vitamin, mineral, and phytonutrient encapsulated liquid formulation, was prepared using a novel proprietary SK713 SLP multi-lamellar non-GMO phospholipid 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. The investigators hypothesize that Prodovite® VMP35 supplement will enhance strength, endurance, and athletic performance; and improve energy output, lean-body muscle mass, increase exercise tolerance, recovery, and improve anabolic parameters in healthy human subjects. The aim of this randomized double-blind placebo-controlled study is to evaluate the effect of oral supplementation of Prodovite® VMP35 on the parameters. The investigators hypothesize that Prodovite® VMP35 supplementation will enhance all the athletic parameters and improve 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.

Detailed Description
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Higher level athletic performance induces greater demands on nutrient and oxygen utilization and hydration. Consistent performance-induced chronic resource depletion from demands of this level can induce an increasing anaerobic, hypoxic/acidic environment, promoting anaerobic metabolic events (i.e. anaerobic glycolysis). Disorders arising from this depletion include chronic inflammation, cramps, and pain, and induce a defensive expenditure of alkalinizing buffers in hemoglobin (i.e. histidine), to prevent a dangerous lowering of blood pH. The physical demands of higher levels of athletic performance deplete biological resources predisposing a greater incidence of chronic problems such as cramps, inflammation, muscle injury and pain. A Phase 1 Pilot Validation Study was conducted in three healthy young trained male athletes (Age: 32-39 years) over a period of 90 consecutive days, with a 2-week intermediate evaluation1. Subjects consumed 30 mL (1-ounce) of Prodovite® VMP35, a World Anti-Doping Association (WADA) compliant iron-free liquid Prodovite® VMP35 vitamin, mineral and phytonutrient complex (MNC) on an empty stomach before engaging in a rigorous exercise regimen in the morning. They consumed another ounce of the Prodovite® VMP35 again mid-afternoon of the same day. Total blood chemistry including free and bound testosterone levels, as well as changes in their exercise performance activities were closely monitored and recorded prior to consuming the Prodovite® VMP35, during the intermediate 2-week evaluation, and then again at the end of the study period. In the 2-week Phase 1 evaluation, 1 ounce of Prodovite® VMP35 taken within 30 minutes before engaging in a rigorous exercise regimen, induced dramatic improvements in athletic exercise performance. Following Prodovite® VMP35 supplementation, physiological health including physical strength, stamina, respiratory parameters, energy level, and sleep quality increased, and blood chemistry parameters were improved. Before Prodovite® VMP35 intake, one subject was struggling with 270 lbs. for 4 reps on the banded reverse Hack Squat, while after supplementation, subject achieved 270 lb.s for 10 reps; rested, then the very next set increased to 320 lbs. for 10 reps. The set after that (the 3rd and final set of that exercise), weight increased again to 360 lbs. for 8 reps. In another subject on the same equipment, pre-Prodovite® VMP35 supplementation, the squat result was 405 lbs. for 10 reps, while post-Prodovite® VMP35 supplementation, the squat increased significantly to 455 lbs. for 6 reps. Pre-Prodovite® VMP35 intake, one exercise in particular, the subject was able to perform the banded reverse hack squat with 160 lbs for one set of 8 reps. After Prodovite® VMP35 intake, the subject increased squat performance to 180 lbs. for 2 sets of 10 reps. On the Hammer Strength banded incline chest press, pre-Prodovite® VMP35, subject's working weight sets were 160 lbs. Post-Prodovite® VMP35 sets increased to 180 lbs. Another increase in strength was experienced in banded Hammer Strength incline press. Pre-VMP35, Subject was doing 180 lbs. for 10 reps, which was increased to 230 lbs. for 10 reps post Prodovite® VMP35. On side lateral dumbbell raises subject's working weight increased from 20 lbs. Pre-Prodovite® VMP35 to 25 lbs. Post- Prodovite® VMP35 supplementation, subjects were able to push a little harder and achieve extra reps with shorter rest periods. Overall, a significant increase in strength was noticed in all subjects and all subjects experienced shorter recovery time between sets and post-workout. Based on these encouraging data, investigators propose to conduct the following full-blown investigation. This pilot investigation inspired our team to conduct a randomized placebo-controlled, double-blind investigation 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). 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 Principal Investigator and Sub-Investigators.

Official Title
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Clinical Study On Prodovite® In Athletic Performance

Conditions
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SPORTS NUTRITION

Intervention / Treatment
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* Dietary Supplement: Prodovite® VMP35


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Agrees to written as well as audio-visual informed consent Ability to understand the risks/benefits of the study protocol Healthy male and female, human subjects 18-74 years of age Subjects experienced with at least six months of regular athletic performance training Exclusion criteria Uncooperative Subjects Subjects with chronic illness (diabetes, cardiovascular disease, cancer, arthritis, etc) or those on prescription medication excluded (except for birth control pills) Any conditions that prevent the subject from participating in physical activities.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blind placebo-controlled investigation to evaluate the efficacy of Prodovite® VMP35 in Boosting Athletic Performance in Athletes
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo will be provided orally to the Placebo Group. Placebo will be blinded and labeled either as A or B. | Dietary Supplement: Prodovite® VMP35<br>* Efficacy of Prodovite® VMP35 will be Assessed as Compared to Placebo<br>|
| Active Comparator: Prodovite® VMP35<br>Prodovite® VMP35 will be provided orally to the Treatment Group. Prodovite® VMP35 will be blinded and labeled either as A or B. | Dietary Supplement: Prodovite® VMP35<br>* Efficacy of Prodovite® VMP35 will be Assessed as Compared to Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight (Kg) | Body Weight (Kg) will be measured in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Height (m) | Height (m) will be measured in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Body Mass Index (kg/m^2) | Body Mass Index (kg/m^2) will be measured in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Body circumference (in cm) | Body Circumference [arm (cm)], [waist (cm)], [hip (cm)], and [calf (cm)] will be measured in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Waist Hip Ratio | Waist Hip Ratio will be measured in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Knee-Heel Length (cm) | Knee-Heel Length (cm) will be measured in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Blood Pressure (mm Hg) | Blood Pressure including Systolic (mm Hg) and Diastolic Blood pressure (mm Hg) will be measured in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Total Cholesterol (mg/dL) | Total Cholesterol (mg/dL) in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Total Testosterone (ng/dL) | Total Testosterone (ng/dL) in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Percent Body Fat (%) | Percent Body Fat (%) Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Bone Mineral Density (g/cm2) | Bone Mineral Density (g/cm2) Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Fat Free Mass [Body fat percent (%) x scale weight = fat mass] | Fat Free Mass [Body fat percent (%) x scale weight = fat mass] Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Lean Body Mass (lbs)[scale weight - fat mass = lean body mass] | Lean Body Mass (lbs)[scale weight - fat mass = lean body mass] Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| In-Body Electrical Impedance Value | Body Composition Analysis (In-Body Electrical Impedance) in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Hand-Grip Strength (lb) | Digital Hand Dynamometer will be used for assessing Hand-Grip Strength (lb) [Percent (%) Change] in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Strength Assessment (lb/reps) | Maximum Push-Up Test for Assessing Upper Body Strength (lb/reps) in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Maximum Power Output (W) (as part of Endurance Assessment) | A Cycle Ergometer will be used for measuring Maximum Power Output (W) in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| VO2 Max (L.Min-1) (as part of Endurance Assessment) | A Cycle Ergometer will be used for measuring VO2 Max (L.Min-1) in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 
| Respiratory Exchange Ratio (RER) (as part of Endurance Assessment) | A Cycle Ergometer will be used for measuring Respiratory Exchange Ratio (RER) in both placebo and Prodovite® groups | Over the period of 90 consecutive days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Compliance | Study Compliance including subject drop-outs and recording of supplement intake will be critically evaluated in Both Placebo- and Prodovite® Groups | Over the period of 90 consecutive days | 
| Adverse Events Monitoring | Adverse Events including headache, nausea, vomiting, diarrhea, rash, fever, muscle cramp and weight gain will be critically Monitored in Both Placebo- and Prodovite® Groups | Over the period of 90 consecutive days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prodovite® VMP35, 90-Day, 150 Subjects, Double-Blind, Placebo-Control Study, Endurance Athletic Performance, Adverse Events Monitoring