Athletic Performance
Conditions
Keywords
Prodovite VMP35; RCT; Athletic Performance
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.
Interventions
DIETARY_SUPPLEMENTClinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement
Assess the Sports Nutrition efficacy of Prodovite VMP35 against the Placebo sample
DIETARY_SUPPLEMENTBroad Spectrum Safety
Benefits in Sports Nutrition
Sponsors
Victory Nutrition International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Double-Blind Placebo-Controlled Study
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion and
Exclusion criteria
Inclusion criteria 1. Agrees to written as well as audio-visual informed consent 2. Ability to understand the risks/benefits of the study protocol 3. Healthy male and female, human subjects 18-74 years of age 4. Subjects experienced with at least six months of regular athletic performance training AND
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endurance Studies | Over a Period of 90 Consecutive Days | Cycle Ergometer, Bench Press and Leg Press |
| 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 |
| Anthropometric Measurements: Body Weight | Over a Period of 90-Consecutive Days | Body Weight (Kilograms) |
| 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) |
| Anthropometric Measurements: Waist-Hip Ratio | Over a Period of 90-Consecutive Days | Waist : Hip Ratio |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Blood Chemistry | Over a Period of 90-Consecutive Days | Blood Chemistry |
| Lipid Profile | Over a Period of 90-Consecutive Days | Complete Lipid Profile |
Countries
United States
Contacts
Primary ContactDEBASIS BAGCHI, PhD
Backup ContactBERNARD W DOWN, MS
Outcome results
None listed