SPORTS NUTRITIONVMP35SPORTNCT04734834
Efficacy Of "Prodovite®" In Athletic Performance
A study testing "Prodovite®" VMP35 in people with SPORTS NUTRITION, run by Victory Nutrition International, Inc. at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- SPORTS NUTRITION
- What is being tested?
- "Prodovite®" VMP35
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2020to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Vitality Medical Wellness Institute, 9350 Benfield Road, Suite #110
Charlotte, North Carolina, 28269
Jeffrey M Galvin, MD, 704-765-9817, drgalvin@vitalitymwi.com
- Recruiting
Hardcore Serious Fitness, 13730 Statesville Road
Huntersville, North Carolina, 28078
Terrance Shane (Bear) Robinson, MS, 704-301-5932, hardcoreseriousfitness@gmail.com
Jeffrey M Galvin, MD
About this study
Official title: Clinical Study On "Prodovite®" In Athletic Performance
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.
Read the detailed description
Higher level athletic performance induces greater demands on nutrient and oxygen utilization and hydration. Consistent performance-induced chronic resource depletion from demands of this level can induce an increasing anaerobic, hypoxic/acidic environment, promoting anaerobic metabolic events (i.e. anaerobic glycolysis). Disorders arising from this depletion include chronic inflammation, cramps, and pain, and induce a defensive expenditure of alkalinizing buffers in hemoglobin (i.e. histidine), to prevent a dangerous lowering of blood pH. The physical demands of higher levels of athletic performance deplete biological resources predisposing a greater incidence of chronic problems such as cramps, inflammation, muscle injury and pain. A Phase 1 Pilot Validation Study was conducted in three healthy young trained male athletes (Age: 32-39 years) over a period of 90 consecutive days, with a 2-week intermediate evaluation1. Subjects consumed 30 mL (1-ounce) of "Prodovite®" VMP35, a World Anti-Doping Association (WADA) compliant iron-free liquid "Prodovite®" VMP35 vitamin, mineral and phytonutrient complex (MNC) on an empty stomach before engaging in a rigorous exercise regimen in the morning. They consumed another ounce of the "Prodovite®" VMP35 again mid-afternoon of the same day. Total blood chemistry including free and bound testosterone levels, as well as changes in their exercise performance activities were closely monitored and recorded prior to consuming the "Prodovite®" VMP35, during the intermediate 2-week evaluation, and then again at the end of the study period. In the 2-week Phase 1 evaluation, 1 ounce of "Prodovite®" VMP35 taken within 30 minutes before engaging in a rigorous exercise regimen, induced dramatic improvements in athletic exercise performance. Following "Prodovite®" VMP35 supplementation, physiological health including physical strength, stamina, respiratory parameters, energy level, and sleep quality increased, and blood chemistry parameters were improved. Before "Prodovite®" VMP35 intake, one subject was struggling with 270 lbs. for 4 reps on the banded reverse Hack Squat, while after supplementation, subject achieved 270 lb.s for 10 reps; rested, then the very next set increased to 320 lbs. for 10 reps. The set after that (the 3rd and final set of that exercise), weight increased again to 360 lbs. for 8 reps. In another subject on the same equipment, pre-"Prodovite®" VMP35 supplementation, the squat result was 405 lbs. for 10 reps, while post-"Prodovite®" VMP35 supplementation, the squat increased significantly to 455 lbs. for 6 reps. Pre-"Prodovite®" VMP35 intake, one exercise in particular, the subject was able to perform the banded reverse hack squat with 160 lbs for one set of 8 reps. After "Prodovite®" VMP35 intake, the subject increased squat performance to 180 lbs. for 2 sets of 10 reps. On the Hammer Strength banded incline chest press, pre-"Prodovite®" VMP35, subject's working weight sets were 160 lbs. Post-"Prodovite®" VMP35 sets increased to 180 lbs. Another increase in strength was experienced in banded Hammer Strength incline press. Pre-VMP35, Subject was doing 180 lbs. for 10 reps, which was increased to 230 lbs. for 10 reps post "Prodovite®" VMP35. On side lateral dumbbell raises subject's working weight increased from 20 lbs. Pre-"Prodovite®" VMP35 to 25 lbs. Post- Prodovite® VMP35 supplementation, subjects were able to push a little harder and achieve extra reps with shorter rest periods. Overall, a significant increase in strength was noticed in all subjects and all subjects experienced shorter recovery time between sets and post-workout. Based on these encouraging data, investigators propose to conduct the following full-blown investigation. This pilot investigation inspired our team to conduct a randomized placebo-controlled, double-blind investigation 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). 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 Principal Investigator and Sub-Investigators.
- Conditions
- SPORTS NUTRITION
- Being tested
- "Prodovite®" VMP35
- Keywords
- "Prodovite®" VMP35, 90-Day, 150 Subjects, Double-Blind, Placebo-Control Study, Endurance Athletic Performance, Adverse Events Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Prodovite®" VMP35Dietary supplement
Efficacy of "Prodovite®" VMP35 will be Assessed as Compared to Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo will be provided orally to the Placebo Group. Placebo will be blinded and labeled either as "A" or "B". Receives: Dietary Supplement: "Prodovite®" VMP35 |
| "Prodovite®" VMP35 | Active comparator | "Prodovite®" VMP35 will be provided orally to the Treatment Group. "Prodovite®" VMP35 will be blinded and labeled either as "A" or "B". Receives: Dietary Supplement: "Prodovite®" VMP35 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight (Kg)
Body Weight (Kg) will be measured in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Height (m)
Height (m) will be measured in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Body Mass Index (kg/m^2)
Body Mass Index (kg/m^2) will be measured in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Body circumference (in cm)
Body Circumference [arm (cm)], [waist (cm)], [hip (cm)], and [calf (cm)] will be measured in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Waist Hip Ratio
Waist Hip Ratio will be measured in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Knee-Heel Length (cm)
Knee-Heel Length (cm) will be measured in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Blood Pressure (mm Hg)
Blood Pressure including Systolic (mm Hg) and Diastolic Blood pressure (mm Hg) will be measured in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Total Cholesterol (mg/dL)
Total Cholesterol (mg/dL) in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Total Testosterone (ng/dL)
Total Testosterone (ng/dL) in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Percent Body Fat (%)
Percent Body Fat (%) Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Bone Mineral Density (g/cm2)
Bone Mineral Density (g/cm2) Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Fat Free Mass [Body fat percent (%) x scale weight = fat mass]
Fat Free Mass [Body fat percent (%) x scale weight = fat mass] Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Lean Body Mass (lbs)[scale weight - fat mass = lean body mass]
Lean Body Mass (lbs)[scale weight - fat mass = lean body mass] Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
In-Body Electrical Impedance Value
Body Composition Analysis (In-Body Electrical Impedance) in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Hand-Grip Strength (lb)
Digital Hand Dynamometer will be used for assessing Hand-Grip Strength (lb) [Percent (%) Change] in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Strength Assessment (lb/reps)
Maximum Push-Up Test for Assessing Upper Body Strength (lb/reps) in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Maximum Power Output (W) (as part of Endurance Assessment)
A Cycle Ergometer will be used for measuring Maximum Power Output (W) in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
VO2 Max (L.Min-1) (as part of Endurance Assessment)
A Cycle Ergometer will be used for measuring VO2 Max (L.Min-1) in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Respiratory Exchange Ratio (RER) (as part of Endurance Assessment)
A Cycle Ergometer will be used for measuring Respiratory Exchange Ratio (RER) in both placebo and "Prodovite®" groups
Measured: Over the period of 90 consecutive days
Secondary outcomes (2)
Study Compliance
Study Compliance including subject drop-outs and recording of supplement intake will be critically evaluated in Both Placebo- and "Prodovite®" Groups
Measured: Over the period of 90 consecutive days
Adverse Events Monitoring
Adverse Events including headache, nausea, vomiting, diarrhea, rash, fever, muscle cramp and weight gain will be critically Monitored in Both Placebo- and "Prodovite®" Groups
Measured: Over the period of 90 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Oct 2020
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SPORTS NUTRITIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind placebo-controlled investigation to evaluate the efficacy of "Prodovite®" VMP35 in Boosting Athletic Performance in Athletes
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Victory Nutrition International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BRUCE S MORRISON, DO, Principal investigator, Medical Director, SPORTS MEDICINE & FAMILY PHYSICIAN, HUNTINGDON VALLEY, PA 19006Jeffrey M Galvin, MD, Study director, Medical Director, Vitality Medical Wellness Institute, Charlotte, NCTerrance Shane (Bear) Robinson, MS, Study director, Director, Hardcore Serious Fitness. Huntersville, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734834
- Sponsor's protocol ID
- VNI-VMP35SPORTS-OCT2019 2020R1
- Other IDs
- VMP35
- Acronym
- VMP35SPORT
- Status last verified
- Jan 2021
- First submitted
- 10 Oct 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a double-blind placebo-controlled study. Confidentiality will be strictly Maintained. No Participant's name will be disclosed. All Data will be Kept with the Principal Investigator Under Lock \& Key
Publications
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.
PubMed 31105509
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study On "Prodovite®" In Athletic Performance
- ClinicalTrials.gov ID
- NCT04734834
- Acronym / sponsor ID
- VMP35SPORT / VNI-VMP35SPORTS-OCT2019 2020R1
- Conditions
- SPORTS NUTRITION
- Keywords
- "Prodovite®" VMP35, 90-Day, 150 Subjects, Double-Blind, Placebo-Control Study, Endurance Athletic Performance, Adverse Events Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Victory Nutrition International, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Higher level athletic performance induces greater demands on nutrient and oxygen utilization and hydration. Consistent performance-induced chronic resource depletion from demands of this level can induce an increasing anaerobic, hypoxic/acidic environment, promoting anaerobic metabolic events (i.e. anaerobic glycolysis). Disorders arising from this depletion include chronic inflammation, cramps, and pain, and induce a defensive expenditure of alkalinizing buffers in hemoglobin (i.e. histidine), to prevent a dangerous lowering of blood pH. The physical demands of higher levels of athletic performance deplete biological resources predisposing a greater incidence of chronic problems such as cramps, inflammation, muscle injury and pain. A Phase 1 Pilot Validation Study was conducted in three healthy young trained male athletes (Age: 32-39 years) over a period of 90 consecutive days, with a 2-week intermediate evaluation1. Subjects consumed 30 mL (1-ounce) of "Prodovite®" VMP35, a World Anti-Doping Association (WADA) compliant iron-free liquid "Prodovite®" VMP35 vitamin, mineral and phytonutrient complex (MNC) on an empty stomach before engaging in a rigorous exercise regimen in the morning. They consumed another ounce of the "Prodovite®" VMP35 again mid-afternoon of the same day. Total blood chemistry including free and bound testosterone levels, as well as changes in their exercise performance activities were closely monitored and recorded prior to consuming the "Prodovite®" VMP35, during the intermediate 2-week evaluation, and then again at the end of the study period. In the 2-week Phase 1 evaluation, 1 ounce of "Prodovite®" VMP35 taken within 30 minutes before engaging in a rigorous exercise regimen, induced dramatic improvements in athletic exercise performance. Following "Prodovite®" VMP35 supplementation, physiological health including physical strength, stamina, respiratory parameters, energy level, and sleep quality increased, and blood chemistry parameters were improved. Before "Prodovite®" VMP35 intake, one subject was struggling with 270 lbs. for 4 reps on the banded reverse Hack Squat, while after supplementation, subject achieved 270 lb.s for 10 reps; rested, then the very next set increased to 320 lbs. for 10 reps. The set after that (the 3rd and final set of that exercise), weight increased again to 360 lbs. for 8 reps. In another subject on the same equipment, pre-"Prodovite®" VMP35 supplementation, the squat result was 405 lbs. for 10 reps, while post-"Prodovite®" VMP35 supplementation, the squat increased significantly to 455 lbs. for 6 reps. Pre-"Prodovite®" VMP35 intake, one exercise in particular, the subject was able to perform the banded reverse hack squat with 160 lbs for one set of 8 reps. After "Prodovite®" VMP35 intake, the subject increased squat performance to 180 lbs. for 2 sets of 10 reps. On the Hammer Strength banded incline chest press, pre-"Prodovite®" VMP35, subject's working weight sets were 160 lbs. Post-"Prodovite®" VMP35 sets increased to 180 lbs. Another increase in strength was experienced in banded Hammer Strength incline press. Pre-VMP35, Subject was doing 180 lbs. for 10 reps, which was increased to 230 lbs. for 10 reps post "Prodovite®" VMP35. On side lateral dumbbell raises subject's working weight increased from 20 lbs. Pre-"Prodovite®" VMP35 to 25 lbs. Post- Prodovite® VMP35 supplementation, subjects were able to push a little harder and achieve extra reps with shorter rest periods. Overall, a significant increase in strength was noticed in all subjects and all subjects experienced shorter recovery time between sets and post-workout. Based on these encouraging data, investigators propose to conduct the following full-blown investigation. This pilot investigation inspired our team to conduct a randomized placebo-controlled, double-blind investigation 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). 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 Principal Investigator and Sub-Investigators.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind placebo-controlled investigation to evaluate the efficacy of "Prodovite®" VMP35 in Boosting Athletic Performance in Athletes
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: "Prodovite®" VMP35Placebo will be provided orally to the Placebo Group. Placebo will be blinded and labeled either as "A" or "B". |
| "Prodovite®" VMP35 | Active comparator | Dietary Supplement: "Prodovite®" VMP35"Prodovite®" VMP35 will be provided orally to the Treatment Group. "Prodovite®" VMP35 will be blinded and labeled either as "A" or "B". |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Prodovite®" VMP35Efficacy of "Prodovite®" VMP35 will be Assessed as Compared to Placebo | Dietary supplement | "Prodovite®" VMP35, Placebo |
Primary outcome
Body Weight (Kg)
Time frame: Over the period of 90 consecutive days
Body Weight (Kg) will be measured in both placebo and "Prodovite®" groups
Height (m)
Time frame: Over the period of 90 consecutive days
Height (m) will be measured in both placebo and "Prodovite®" groups
Body Mass Index (kg/m^2)
Time frame: Over the period of 90 consecutive days
Body Mass Index (kg/m^2) will be measured in both placebo and "Prodovite®" groups
Body circumference (in cm)
Time frame: Over the period of 90 consecutive days
Body Circumference [arm (cm)], [waist (cm)], [hip (cm)], and [calf (cm)] will be measured in both placebo and "Prodovite®" groups
Waist Hip Ratio
Time frame: Over the period of 90 consecutive days
Waist Hip Ratio will be measured in both placebo and "Prodovite®" groups
Knee-Heel Length (cm)
Time frame: Over the period of 90 consecutive days
Knee-Heel Length (cm) will be measured in both placebo and "Prodovite®" groups
Blood Pressure (mm Hg)
Time frame: Over the period of 90 consecutive days
Blood Pressure including Systolic (mm Hg) and Diastolic Blood pressure (mm Hg) will be measured in both placebo and "Prodovite®" groups
Total Cholesterol (mg/dL)
Time frame: Over the period of 90 consecutive days
Total Cholesterol (mg/dL) in both placebo and "Prodovite®" groups
Total Testosterone (ng/dL)
Time frame: Over the period of 90 consecutive days
Total Testosterone (ng/dL) in both placebo and "Prodovite®" groups
Percent Body Fat (%)
Time frame: Over the period of 90 consecutive days
Percent Body Fat (%) Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and "Prodovite®" groups
Bone Mineral Density (g/cm2)
Time frame: Over the period of 90 consecutive days
Bone Mineral Density (g/cm2) Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and "Prodovite®" groups
Fat Free Mass [Body fat percent (%) x scale weight = fat mass]
Time frame: Over the period of 90 consecutive days
Fat Free Mass [Body fat percent (%) x scale weight = fat mass] Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and "Prodovite®" groups
Lean Body Mass (lbs)[scale weight - fat mass = lean body mass]
Time frame: Over the period of 90 consecutive days
Lean Body Mass (lbs)[scale weight - fat mass = lean body mass] Measurement by Dual Energy X-Ray Absorptiometry (DEXA) in both placebo and "Prodovite®" groups
In-Body Electrical Impedance Value
Time frame: Over the period of 90 consecutive days
Body Composition Analysis (In-Body Electrical Impedance) in both placebo and "Prodovite®" groups
Hand-Grip Strength (lb)
Time frame: Over the period of 90 consecutive days
Digital Hand Dynamometer will be used for assessing Hand-Grip Strength (lb) [Percent (%) Change] in both placebo and "Prodovite®" groups
Strength Assessment (lb/reps)
Time frame: Over the period of 90 consecutive days
Maximum Push-Up Test for Assessing Upper Body Strength (lb/reps) in both placebo and "Prodovite®" groups
Maximum Power Output (W) (as part of Endurance Assessment)
Time frame: Over the period of 90 consecutive days
A Cycle Ergometer will be used for measuring Maximum Power Output (W) in both placebo and "Prodovite®" groups
VO2 Max (L.Min-1) (as part of Endurance Assessment)
Time frame: Over the period of 90 consecutive days
A Cycle Ergometer will be used for measuring VO2 Max (L.Min-1) in both placebo and "Prodovite®" groups
Respiratory Exchange Ratio (RER) (as part of Endurance Assessment)
Time frame: Over the period of 90 consecutive days
A Cycle Ergometer will be used for measuring Respiratory Exchange Ratio (RER) in both placebo and "Prodovite®" groups
2 secondary outcomes
Study Compliance
Time frame: Over the period of 90 consecutive days
Adverse Events Monitoring
Time frame: Over the period of 90 consecutive days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Results publication: PubMed 31105509Corbier 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.
- Individual participant dataSharing planned: No. This is a double-blind placebo-controlled study. Confidentiality will be strictly Maintained. No Participant's name will be disclosed. All Data will be Kept with the Principal Investigator Under Lock \& Key
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Athletic Performance, Exercise
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BRUCE S MORRISON, DO principal investigator
Medical Director, SPORTS MEDICINE & FAMILY PHYSICIAN, HUNTINGDON VALLEY, PA 19006
Jeffrey M Galvin, MD study director
Medical Director, Vitality Medical Wellness Institute, Charlotte, NC
Terrance Shane (Bear) Robinson, MS study director
Director, Hardcore Serious Fitness. Huntersville, NC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Prodovite®" VMP35 in people with SPORTS NUTRITION, run by Victory Nutrition International, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BRUCE S MORRISON, DO ((215)947-9131, drmorrisonfm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (Kg) (time frame: Over the period of 90 consecutive days). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04734834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.