Clinical trial NCT04121481: Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance
Official title: Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Athletic Performance
Keywords: Prodovite VMP35; RCT; Athletic Performance
Lead sponsor: Victory Nutrition International, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anthropometric Measurements: Body Weight
timeFrame: Over a Period of 90-Consecutive Days
measure: Anthropometric Measurements: Height
timeFrame: Over a Period of 90-Consecutive Days
measure: Anthropometric Measurements: Waist Circumference
timeFrame: Over a Period of 90-Consecutive Days
measure: Anthropometric Measurements: Waist-Hip Ratio
timeFrame: Over a Period of 90-Consecutive Days
measure: Anthropometric Measurements: Blood Pressure (mmHg)
timeFrame: Over a Period of 90-Consecutive Days
measure: Body Composition and Bone Mineral Density: DEXA (GE)
timeFrame: Over a Period of 90-Consecutive Days
measure: Ergometric Assessment: Treadmill
timeFrame: Over a Period of 90-Consecutive Days
measure: Handgrip Dynamometer
timeFrame: Over a Period of 90-Consecutive Days
measure: Respiration Quality and Rate: Spirometer
timeFrame: Over a Period of 90-Consecutive Days
measure: Endurance Studies
timeFrame: Over a Period of 90 Consecutive Days
Secondary outcomes:
measure: Lipid Profile
timeFrame: Over a Period of 90-Consecutive Days
measure: Total Blood Chemistry
timeFrame: Over a Period of 90-Consecutive Days
Other outcomes:
Locations:
city: Cornelius
country: United States
facility: Champions Sports Performance & Hardcore Serious Fitness
state: North Carolina
Study officials:
affiliation: SPORTS NUTRITION & FAMILY MEDICINE
name: BRUCE S MORRISON, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.