NCT04734834

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

February 4, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

October 10, 2020

Last Update Submit

February 1, 2021

Conditions

SPORTS NUTRITION

Keywords

"Prodovite®" VMP3590-Day150 SubjectsDouble-Blind, Placebo-Control StudyEndurance Athletic PerformanceAdverse Events Monitoring

Outcome Measures

Primary Outcomes (19)

  • 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 Outcomes (2)

  • Study Compliance

    Over the period of 90 consecutive days

  • Adverse Events Monitoring

    Over the period of 90 consecutive days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: "Prodovite®" VMP35

"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".

Dietary Supplement: "Prodovite®" VMP35

Interventions

"Prodovite®" VMP35DIETARY_SUPPLEMENT

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

"Prodovite®" VMP35Placebo

Eligibility Criteria

Age18 Years - 74 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsA Total of 150 Healthy Male and Female Subjects (50:50) will be recruited after rigorous Evaluation
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Charlotte, North Carolina, 28269, United States

RECRUITING

Hardcore Serious Fitness, 13730 Statesville Road

Huntersville, North Carolina, 28078, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31105509RESULT

Study Officials

  • BRUCE S MORRISON, DO

    Medical Director, SPORTS MEDICINE & FAMILY PHYSICIAN, HUNTINGDON VALLEY, PA 19006

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Central Study Contacts

BRUCE S MORRISON, DO

CONTACT

(215)947-9131drmorrisonfm@gmail.com

Berrnard W Downs

CONTACT

2155639339billd@vni.life

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A double-blind placebo-controlled investigation in 150 subjects,
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A double-blind placebo-controlled investigation to evaluate the efficacy of "Prodovite®" VMP35 in Boosting Athletic Performance in Athletes
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2020

First Posted

February 2, 2021

Study Start

October 1, 2020

Primary Completion

October 30, 2021

Study Completion

October 30, 2022

Last Updated

February 4, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

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

Locations

US(2)