Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance

Conditions
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Athletic Performance

Intervention / Treatment
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* Dietary Supplement: Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement
* Dietary Supplement: Broad Spectrum Safety


Participation Criteria
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Eligibility Criteria
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Inclusion and Exclusion Criteria 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 AND 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Approximately a total of 75 participants will be assigned in the Placebo Group (two divided doses will be given) | Dietary Supplement: Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement<br>* Assess the Sports Nutrition efficacy of Prodovite VMP35 against the Placebo sample<br>* Other names: Physical Well Being, Health Status, Detailed Lipid Profile and Blood Chemistry Analysis; Adverse Event Monitoring; Compliance;Dietary Supplement: Broad Spectrum Safety<br>* Benefits in Sports Nutrition<br>* Other names: Sports Nutrition and Health Staus;|
| Active Comparator: Treatment Group<br>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 | Dietary Supplement: Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement<br>* Assess the Sports Nutrition efficacy of Prodovite VMP35 against the Placebo sample<br>* Other names: Physical Well Being, Health Status, Detailed Lipid Profile and Blood Chemistry Analysis; Adverse Event Monitoring; Compliance;Dietary Supplement: Broad Spectrum Safety<br>* Benefits in Sports Nutrition<br>* Other names: Sports Nutrition and Health Staus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric Measurements: Body Weight | Body Weight (Kilograms) | Over a Period of 90-Consecutive Days | 
| Anthropometric Measurements: Height | Height (Meters) | Over a Period of 90-Consecutive Days | 
| Anthropometric Measurements: Waist Circumference | Waist Circumference (Meters) | Over a Period of 90-Consecutive Days | 
| Anthropometric Measurements: Waist-Hip Ratio | Waist : Hip Ratio | Over a Period of 90-Consecutive Days | 
| Anthropometric Measurements: Blood Pressure (mmHg) | Blood Pressure (mmHg) | Over a Period of 90-Consecutive Days | 
| Body Composition and Bone Mineral Density: DEXA (GE) | DEXA and Bone Mineral Density | Over a Period of 90-Consecutive Days | 
| Ergometric Assessment: Treadmill | Ergometric measurements | Over a Period of 90-Consecutive Days | 
| Handgrip Dynamometer | Handgrip strength | Over a Period of 90-Consecutive Days | 
| Respiration Quality and Rate: Spirometer | Respiration Quality, VO2 and VCO2 assessments | Over a Period of 90-Consecutive Days | 
| Endurance Studies | Cycle Ergometer, Bench Press and Leg Press | Over a Period of 90 Consecutive Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Profile | Complete Lipid Profile | Over a Period of 90-Consecutive Days | 
| Total Blood Chemistry | Blood Chemistry | Over a 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; RCT; Athletic Performance