Efficacy Of "Prodovite®" In Athletic Performance
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: SPORTS NUTRITION
In brief
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.
Key facts
- Study ID
- NCT04734834
- Run by
- Victory Nutrition International, Inc.
- People needed
- 150
- Starts
- 2020-10-01
- Expected to finish
- 2022-10-30
- Last updated by the study team
- 2021-02-04
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Vitality Medical Wellness Institute, 9350 Benfield Road, Suite #110 — Charlotte, North Carolina, United States (enrolling)
- Hardcore Serious Fitness, 13730 Statesville Road — Huntersville, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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