Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance
VMP35Sport
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
1 active site
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
First Submitted
Initial submission to the registry
October 3, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Start
First participant enrolled
May 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedMay 7, 2021
May 1, 2021
9 months
October 3, 2019
May 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Anthropometric Measurements: Body Weight
Body Weight (Kilograms)
Over a Period of 90-Consecutive Days
Anthropometric Measurements: Height
Height (Meters)
Over a Period of 90-Consecutive Days
Anthropometric Measurements: Waist Circumference
Waist Circumference (Meters)
Over a Period of 90-Consecutive Days
Anthropometric Measurements: Waist-Hip Ratio
Waist : Hip Ratio
Over a Period of 90-Consecutive Days
Anthropometric Measurements: Blood Pressure (mmHg)
Blood Pressure (mmHg)
Over a Period of 90-Consecutive Days
Body Composition and Bone Mineral Density: DEXA (GE)
DEXA and Bone Mineral Density
Over a Period of 90-Consecutive Days
Ergometric Assessment: Treadmill
Ergometric measurements
Over a Period of 90-Consecutive Days
Handgrip Dynamometer
Handgrip strength
Over a Period of 90-Consecutive Days
Respiration Quality and Rate: Spirometer
Respiration Quality, VO2 and VCO2 assessments
Over a Period of 90-Consecutive Days
Endurance Studies
Cycle Ergometer, Bench Press and Leg Press
Over a Period of 90 Consecutive Days
Secondary Outcomes (2)
Lipid Profile
Over a Period of 90-Consecutive Days
Total Blood Chemistry
Over a Period of 90-Consecutive Days
Study Arms (2)
Placebo
PLACEBO COMPARATORApproximately a total of 75 participants will be assigned in the Placebo Group (two divided doses will be given)
Treatment Group
ACTIVE COMPARATORApproximately 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
Assess the Sports Nutrition efficacy of Prodovite VMP35 against the Placebo sample
Benefits in Sports Nutrition
Eligibility Criteria
You may not 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
- AND
- 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 (1)
Champions Sports Performance & Hardcore Serious Fitness
Cornelius, North Carolina, 28031, United States
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BRUCE S MORRISON, DO
SPORTS NUTRITION & FAMILY MEDICINE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Double-Blind Placebo-Controlled Study
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2019
First Posted
October 10, 2019
Study Start
May 15, 2021
Primary Completion
January 31, 2022
Study Completion
September 30, 2022
Last Updated
May 7, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
IT IS A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY