Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance (VMP35Sport)

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.

Study Overview

• Status: Recruiting
• Conditions: Athletic Performance
• Intervention / Treatment: Dietary supplement: Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement; Dietary supplement: Broad Spectrum Safety

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.

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

Contacts and Locations

• Study Contact: Name: DEBASIS BAGCHI, PhD; Phone Number: (925)948-6951; Email: debasisbagchi@gmail.com; debasis@vni.life
• Study Contact Backup: Name: BERNARD W DOWN, MS; Phone Number: (215)513-4136; Email: billd@vni.life

Study Locations

• United States
  • North Carolina
    • Cornelius, North Carolina, United States, 28031
      • Recruiting
      • Champions Sports Performance & Hardcore Serious Fitness
      • Contact: Greg O'Connor, MS; Phone Number: 704-439-1111; Email: greg@championssportsperformance.com
      • Contact: Bear Robinson, MS; Phone Number: (704)301-5932; Email: hardcoreseriousfitness@gmail.com
      • Sub-Investigator: GREG O'CONNOR, MS
      • Sub-Investigator: BEAR ROBINSON, MS
      • Sub-Investigator: KEN NAZEMETZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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; Assess the Sports Nutrition efficacy of Prodovite VMP35 against the Placebo sample; Other Names: Physical Well Being, Health Status, Detailed Lipid Profile and Blood Chemistry Analysis; Adverse Event Monitoring; Compliance; Dietary supplement: Broad Spectrum Safety; Benefits in Sports Nutrition; Other Names: Sports Nutrition and Health Staus
Active Comparator: Treatment Group; 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; Assess the Sports Nutrition efficacy of Prodovite VMP35 against the Placebo sample; Other Names: Physical Well Being, Health Status, Detailed Lipid Profile and Blood Chemistry Analysis; Adverse Event Monitoring; Compliance; Dietary supplement: Broad Spectrum Safety; Benefits in Sports Nutrition; Other Names: Sports Nutrition and Health Staus

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Victory Nutrition International, Inc.
• Investigators: Principal Investigator: BRUCE S MORRISON, DO, SPORTS NUTRITION & FAMILY MEDICINE

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 (Anticipated): May 15, 2021
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Prodovite VMP35; RCT; Athletic Performance
• Other Study ID Numbers: VNI-VMP35-SPORTS-OCT 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IT IS A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY

Drug and device information, study documents

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