Recruiting

Prodovite®

Sponsor:

Victory Nutrition International, Inc.

Code:

NCT04121481

Conditions

Athletic Performance

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement

Broad Spectrum Safety

Study Details

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.

Conditions

Athletic Performance

Study ID

NCT04121481

Start date

May 15, 2021

Status verified date

May, 2021

Completion date

Sep 30, 2022

Anticipated

Primary completion date

Jan 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Approximately a total of 75 participants will be assigned in the Placebo Group (two divided doses will be given)

active comparator: Treatment Group

Approximately a total of 75 participants will be assigned in the Treatment Group (two divided doses will be given) Adverse Event Monitoring will be Strictly Enforced

Interventions

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

Primary outcome measure

  • Anthropometric Measurements: Body Weight [ Time Frame: Over a Period of 90-Consecutive Days ]
  • Anthropometric Measurements: Height [ Time Frame: Over a Period of 90-Consecutive Days ]
  • Anthropometric Measurements: Waist Circumference [ Time Frame: Over a Period of 90-Consecutive Days ]
  • Anthropometric Measurements: Waist-Hip Ratio [ Time Frame: Over a Period of 90-Consecutive Days ]
  • Anthropometric Measurements: Blood Pressure (mmHg) [ Time Frame: Over a Period of 90-Consecutive Days ]
  • Body Composition and Bone Mineral Density: DEXA (GE) [ Time Frame: Over a Period of 90-Consecutive Days ]
  • Ergometric Assessment: Treadmill [ Time Frame: Over a Period of 90-Consecutive Days ]
  • Handgrip Dynamometer [ Time Frame: Over a Period of 90-Consecutive Days ]
  • Respiration Quality and Rate: Spirometer [ Time Frame: Over a Period of 90-Consecutive Days ]
  • Endurance Studies [ Time Frame: Over a Period of 90 Consecutive Days ]

Central Contacts and Locations

Locations

Champions Sports Performance & Hardcore Serious Fitness

Recruiting

Cornelius, North Carolina, United States, 28031

Contacts

More Information

Sponsor

Victory Nutrition International, Inc.

Last update posted

May 7, 2021

Last verified

May, 2021

Keywords

  • Prodovite VMP35; RCT; Athletic Performance

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 2021-05-07.