Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance

Athletic Performance Clinical Trial

— VMP35Sport  

Official title:

Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04121481
• Other study ID #: VNI-VMP35-SPORTS-OCT 2019
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2021
• Source: Victory Nutrition International, Inc.
• Contact: DEBASIS BAGCHI, PhD
• Phone: (925)948-6951
• Email: debasisbagchi[@]gmail.com; debasis[@]vni.life
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Athletic Performance

Intervention

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
• Broad Spectrum Safety
Benefits in Sports Nutrition

Locations

Country	Name	City	State
United States	Champions Sports Performance & Hardcore Serious Fitness	Cornelius	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Victory Nutrition International, Inc.

Country where clinical trial is conducted

United States, 

References & 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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometric Measurements: Body Weight	Body Weight (Kilograms)	Over a Period of 90-Consecutive Days
Primary	Anthropometric Measurements: Height	Height (Meters)	Over a Period of 90-Consecutive Days
Primary	Anthropometric Measurements: Waist Circumference	Waist Circumference (Meters)	Over a Period of 90-Consecutive Days
Primary	Anthropometric Measurements: Waist-Hip Ratio	Waist : Hip Ratio	Over a Period of 90-Consecutive Days
Primary	Anthropometric Measurements: Blood Pressure (mmHg)	Blood Pressure (mmHg)	Over a Period of 90-Consecutive Days
Primary	Body Composition and Bone Mineral Density: DEXA (GE)	DEXA and Bone Mineral Density	Over a Period of 90-Consecutive Days
Primary	Ergometric Assessment: Treadmill	Ergometric measurements	Over a Period of 90-Consecutive Days
Primary	Handgrip Dynamometer	Handgrip strength	Over a Period of 90-Consecutive Days
Primary	Respiration Quality and Rate: Spirometer	Respiration Quality, VO2 and VCO2 assessments	Over a Period of 90-Consecutive Days
Primary	Endurance Studies	Cycle Ergometer, Bench Press and Leg Press	Over a Period of 90 Consecutive Days
Secondary	Lipid Profile	Complete Lipid Profile	Over a Period of 90-Consecutive Days
Secondary	Total Blood Chemistry	Blood Chemistry	Over a Period of 90-Consecutive Days