Recruiting

Prodovite

Sponsor:

Victory Nutrition International, Inc.

Code:

NCT04734834

Conditions

SPORTS NUTRITION

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

"Prodovite®" VMP35

Study Details

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.

Conditions

SPORTS NUTRITION

Study ID

NCT04734834

Start date

Oct 1, 2020

Status verified date

Jan, 2021

Completion date

Oct 30, 2022

Anticipated

Primary completion date

Oct 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

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

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".

Interventions

"Prodovite®" VMP35

Efficacy of "Prodovite®" VMP35 will be Assessed as Compared to Placebo

Primary outcome measure

  • Body Weight (Kg) [ Time Frame: Over the period of 90 consecutive days ]
  • Height (m) [ Time Frame: Over the period of 90 consecutive days ]
  • Body Mass Index (kg/m^2) [ Time Frame: Over the period of 90 consecutive days ]
  • Body circumference (in cm) [ Time Frame: Over the period of 90 consecutive days ]
  • Waist Hip Ratio [ Time Frame: Over the period of 90 consecutive days ]
  • Knee-Heel Length (cm) [ Time Frame: Over the period of 90 consecutive days ]
  • Blood Pressure (mm Hg) [ Time Frame: Over the period of 90 consecutive days ]
  • Total Cholesterol (mg/dL) [ Time Frame: Over the period of 90 consecutive days ]
  • Total Testosterone (ng/dL) [ Time Frame: Over the period of 90 consecutive days ]
  • Percent Body Fat (%) [ Time Frame: Over the period of 90 consecutive days ]
  • Bone Mineral Density (g/cm2) [ Time Frame: Over the period of 90 consecutive days ]
  • Fat Free Mass [Body fat percent (%) x scale weight = fat mass] [ Time Frame: Over the period of 90 consecutive days ]
  • Lean Body Mass (lbs)[scale weight - fat mass = lean body mass] [ Time Frame: Over the period of 90 consecutive days ]
  • In-Body Electrical Impedance Value [ Time Frame: Over the period of 90 consecutive days ]
  • Hand-Grip Strength (lb) [ Time Frame: Over the period of 90 consecutive days ]
  • Strength Assessment (lb/reps) [ Time Frame: Over the period of 90 consecutive days ]
  • Maximum Power Output (W) (as part of Endurance Assessment) [ Time Frame: Over the period of 90 consecutive days ]
  • VO2 Max (L.Min-1) (as part of Endurance Assessment) [ Time Frame: Over the period of 90 consecutive days ]
  • Respiratory Exchange Ratio (RER) (as part of Endurance Assessment) [ Time Frame: Over the period of 90 consecutive days ]

Central Contacts and Locations

Central contacts

BRUCE S MORRISON, DO

(215)947-9131drmorrisonfm@gmail.com

Berrnard W Downs

2155639339billd@vni.life

Locations

Vitality Medical Wellness Institute, 9350 Benfield Road, Suite #110

Recruiting

Charlotte, North Carolina, United States, 28269

Contacts

Jeffrey M Galvin, MD

704-765-9817drgalvin@vitalitymwi.com

Hardcore Serious Fitness, 13730 Statesville Road

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

Terrance Shane (Bear) Robinson, MS

704-301-5932hardcoreseriousfitness@gmail.com

More Information

Sponsor

Victory Nutrition International, Inc.

Last update posted

Feb 4, 2021

Last verified

Jan, 2021

Keywords

  • "Prodovite®" VMP35
  • 90-Day
  • 150 Subjects
  • Double-Blind, Placebo-Control Study
  • Endurance Athletic Performance
  • Adverse Events Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Victory Nutrition International, Inc. on 2021-02-04.