Efficacy Of "Prodovite®" In Athletic Performance (VMP35SPORT)

Clinical Study On "Prodovite®" In Athletic Performance

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.

Study Overview

• Status: Recruiting
• Conditions: SPORTS NUTRITION
• Intervention / Treatment: Dietary supplement: "Prodovite®" VMP35

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BRUCE S MORRISON, DO; Phone Number: (215)947-9131; Email: drmorrisonfm@gmail.com
• Study Contact Backup: Name: Berrnard W Downs; Phone Number: 2155639339; Email: billd@vni.life

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28269
      • Recruiting
      • Vitality Medical Wellness Institute, 9350 Benfield Road, Suite #110
      • Contact: Jeffrey M Galvin, MD; Phone Number: 704-765-9817; Email: drgalvin@vitalitymwi.com
    • Huntersville, North Carolina, United States, 28078
      • Recruiting
      • Hardcore Serious Fitness, 13730 Statesville Road
      • Contact: Terrance Shane (Bear) Robinson, MS; Phone Number: 704-301-5932; Email: hardcoreseriousfitness@gmail.com
      • Sub-Investigator: Jeffrey M Galvin, MD
      • Sub-Investigator: Terrance Shane (Bear) Robinson, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion criteria

1. Uncooperative Subjects
2. Subjects with chronic illness (diabetes, cardiovascular disease, cancer, arthritis, etc) or those on prescription medication excluded (except for birth control pills)
3. Any conditions that prevent the subject from participating in physical activities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo will be provided orally to the Placebo Group. Placebo will be blinded and labeled either as "A" or "B".	Dietary supplement: "Prodovite®" VMP35; Efficacy of "Prodovite®" VMP35 will be Assessed as Compared to Placebo
Active Comparator: "Prodovite®" VMP35; "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; Efficacy of "Prodovite®" VMP35 will be Assessed as Compared to Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Victory Nutrition International, Inc.
• Investigators: Principal Investigator: BRUCE S MORRISON, DO, Medical Director, SPORTS MEDICINE & FAMILY PHYSICIAN, HUNTINGDON VALLEY, PA 19006; Study Director: Jeffrey M Galvin, MD, Medical Director, Vitality Medical Wellness Institute, Charlotte, NC; Study Director: Terrance Shane (Bear) Robinson, MS, Director, Hardcore Serious Fitness. Huntersville, NC

Publications and helpful links

General Publications

• Corbier JR, Downs BW, Kushner S, Aloisio T, Bagchi D, Bagchi M. VMP35 MNC, a novel iron-free supplement, enhances cytoprotection against anemia in human subjects: a novel hypothesis. Food Nutr Res. 2019 May 9;63. doi: 10.29219/fnr.v63.3410. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: "Prodovite®" VMP35; 90-Day; 150 Subjects; Double-Blind, Placebo-Control Study; Endurance Athletic Performance; Adverse Events Monitoring
• Other Study ID Numbers: VNI-VMP35SPORTS-OCT2019 2020R1; VMP35 (Registry Identifier: VNI Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This is a double-blind placebo-controlled study. Confidentiality will be strictly Maintained. No Participant's name will be disclosed. All Data will be Kept with the Principal Investigator Under Lock & Key

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No