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Clinical Trials/NCT04734834
NCT04734834UnknownNot Applicable

Clinical Study On "Prodovite®" In Athletic Performance

Victory Nutrition International, Inc.2 sites in 1 country150 target enrollmentStarted: October 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
150
Locations
2
Primary Endpoint
Total Cholesterol (mg/dL)

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

A double-blind placebo-controlled investigation in 150 subjects,

Eligibility Criteria

Ages
18 Years to 74 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Placebo

Placebo Comparator

Placebo will be provided orally to the Placebo Group. Placebo will be blinded and labeled either as "A" or "B".

Intervention: "Prodovite®" VMP35 (Dietary Supplement)

"Prodovite®" VMP35

Active Comparator

"Prodovite®" VMP35 will be provided orally to the Treatment Group. "Prodovite®" VMP35 will be blinded and labeled either as "A" or "B".

Intervention: "Prodovite®" VMP35 (Dietary Supplement)

Outcomes

Primary Outcomes

Total Cholesterol (mg/dL)

Time Frame: Over the period of 90 consecutive days

Total Cholesterol (mg/dL) in both placebo and "Prodovite®" groups

Height (m)

Time Frame: Over the period of 90 consecutive days

Height (m) will be measured in both placebo and "Prodovite®" groups

Blood Pressure (mm Hg)

Time Frame: Over the period of 90 consecutive days

Blood Pressure including Systolic (mm Hg) and Diastolic Blood pressure (mm Hg) will be measured in both placebo and "Prodovite®" groups

Hand-Grip Strength (lb)

Time Frame: Over the period of 90 consecutive days

Digital Hand Dynamometer will be used for assessing Hand-Grip Strength (lb) \[Percent (%) Change\] in both placebo and "Prodovite®" groups

Strength Assessment (lb/reps)

Time Frame: Over the period of 90 consecutive days

Maximum Push-Up Test for Assessing Upper Body Strength (lb/reps) in both placebo and "Prodovite®" groups

Body Weight (Kg)

Time Frame: Over the period of 90 consecutive days

Body Weight (Kg) will be measured in both placebo and "Prodovite®" groups

Body Mass Index (kg/m^2)

Time Frame: Over the period of 90 consecutive days

Body Mass Index (kg/m\^2) will be measured in both placebo and "Prodovite®" groups

Maximum Power Output (W) (as part of Endurance Assessment)

Time Frame: Over the period of 90 consecutive days

A Cycle Ergometer will be used for measuring Maximum Power Output (W) in both placebo and "Prodovite®" groups

In-Body Electrical Impedance Value

Time Frame: Over the period of 90 consecutive days

Body Composition Analysis (In-Body Electrical Impedance) in both placebo and "Prodovite®" groups

Body circumference (in cm)

Time Frame: Over the period of 90 consecutive days

Body Circumference \[arm (cm)\], \[waist (cm)\], \[hip (cm)\], and \[calf (cm)\] will be measured in both placebo and "Prodovite®" groups

Waist Hip Ratio

Time Frame: Over the period of 90 consecutive days

Waist Hip Ratio will be measured in both placebo and "Prodovite®" groups

Knee-Heel Length (cm)

Time Frame: Over the period of 90 consecutive days

Knee-Heel Length (cm) will be measured in both placebo and "Prodovite®" groups

Fat Free Mass [Body fat percent (%) x scale weight = fat mass]

Time Frame: Over the period of 90 consecutive days

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

Lean Body Mass (lbs)[scale weight - fat mass = lean body mass]

Time Frame: Over the period of 90 consecutive days

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

VO2 Max (L.Min-1) (as part of Endurance Assessment)

Time Frame: Over the period of 90 consecutive days

A Cycle Ergometer will be used for measuring VO2 Max (L.Min-1) in both placebo and "Prodovite®" groups

Respiratory Exchange Ratio (RER) (as part of Endurance Assessment)

Time Frame: Over the period of 90 consecutive days

A Cycle Ergometer will be used for measuring Respiratory Exchange Ratio (RER) in both placebo and "Prodovite®" groups

Total Testosterone (ng/dL)

Time Frame: Over the period of 90 consecutive days

Total Testosterone (ng/dL) in both placebo and "Prodovite®" groups

Percent Body Fat (%)

Time Frame: Over the period of 90 consecutive days

Percent Body Fat (%) Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and "Prodovite®" groups

Bone Mineral Density (g/cm2)

Time Frame: Over the period of 90 consecutive days

Bone Mineral Density (g/cm2) Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and "Prodovite®" groups

Secondary Outcomes

  • Adverse Events Monitoring(Over the period of 90 consecutive days)
  • Study Compliance(Over the period of 90 consecutive days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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