Efficacy Of "Prodovite®" In Athletic Performance (VMP35SPORT)
Clinical Study On "Prodovite®" In Athletic Performance
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: BRUCE S MORRISON, DO
- Phone Number: (215)947-9131
- Email: drmorrisonfm@gmail.com
Study Contact Backup
- Name: Berrnard W Downs
- Phone Number: 2155639339
- Email: billd@vni.life
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28269
- Recruiting
- Vitality Medical Wellness Institute, 9350 Benfield Road, Suite #110
-
Contact:
- Jeffrey M Galvin, MD
- Phone Number: 704-765-9817
- Email: drgalvin@vitalitymwi.com
-
Huntersville, North Carolina, United States, 28078
- Recruiting
- Hardcore Serious Fitness, 13730 Statesville Road
-
Contact:
- Terrance Shane (Bear) Robinson, MS
- Phone Number: 704-301-5932
- Email: hardcoreseriousfitness@gmail.com
-
Sub-Investigator:
- Jeffrey M Galvin, MD
-
Sub-Investigator:
- Terrance Shane (Bear) Robinson, MS
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- 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
Exclusion criteria
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Placebo will be provided orally to the Placebo Group.
Placebo will be blinded and labeled either as "A" or "B".
|
Efficacy of "Prodovite®" VMP35 will be Assessed as Compared to Placebo
|
|
Active Comparator: "Prodovite®" VMP35
"Prodovite®" VMP35 will be provided orally to the Treatment Group.
"Prodovite®" VMP35 will be blinded and labeled either as "A" or "B".
|
Efficacy of "Prodovite®" VMP35 will be Assessed as Compared to Placebo
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Weight (Kg)
Time Frame: Over the period of 90 consecutive days
|
Body Weight (Kg) will be measured in both placebo and "Prodovite®" groups
|
Over the period of 90 consecutive days
|
|
Height (m)
Time Frame: Over the period of 90 consecutive days
|
Height (m) will be measured in both placebo and "Prodovite®" groups
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
Waist Hip Ratio
Time Frame: Over the period of 90 consecutive days
|
Waist Hip Ratio will be measured in both placebo and "Prodovite®" groups
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
Total Cholesterol (mg/dL)
Time Frame: Over the period of 90 consecutive days
|
Total Cholesterol (mg/dL) in both placebo and "Prodovite®" groups
|
Over the period of 90 consecutive days
|
|
Total Testosterone (ng/dL)
Time Frame: Over the period of 90 consecutive days
|
Total Testosterone (ng/dL) in both placebo and "Prodovite®" groups
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
|
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
|
Over the period of 90 consecutive days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Study Compliance
Time Frame: Over the period of 90 consecutive days
|
Study Compliance including subject drop-outs and recording of supplement intake will be critically evaluated in Both Placebo- and "Prodovite®" Groups
|
Over the period of 90 consecutive days
|
|
Adverse Events Monitoring
Time Frame: Over the period of 90 consecutive days
|
Adverse Events including headache, nausea, vomiting, diarrhea, rash, fever, muscle cramp and weight gain will be critically Monitored in Both Placebo- and "Prodovite®" Groups
|
Over the period of 90 consecutive days
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: BRUCE S MORRISON, DO, Medical Director, SPORTS MEDICINE & FAMILY PHYSICIAN, HUNTINGDON VALLEY, PA 19006
- Study Director: Jeffrey M Galvin, MD, Medical Director, Vitality Medical Wellness Institute, Charlotte, NC
- Study Director: Terrance Shane (Bear) Robinson, MS, Director, Hardcore Serious Fitness. Huntersville, NC
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- VNI-VMP35SPORTS-OCT2019 2020R1
- VMP35 (Registry Identifier: VNI Inc)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on SPORTS NUTRITION
-
NCT05658133Completed
-
NCT06444698CompletedSports Nutrition
-
NCT05726435CompletedMicrobiota | Sports | Dietary Fiber | Nutrition Surveys | Sports Nutrition
-
NCT07114341CompletedSports Nutritional Sciences | Ergogenic Support | Sports Performance in Children | Ergogenic Athletic Performance | Sport Nutrition
-
NCT05489666Not yet recruitingNutrition Status | Sports Nutritional Sciences | Nutritional Requirements
-
NCT04549610RecruitingSupplementation | Recovery | Muscle Damage | Sport | Sports Nutrition
-
NCT05516212RecruitingSupplementation | Sports Nutrition | Ergogenic Support | Discipline-specific Performance
-
NCT05444959CompletedSupplementation | Sport | Sports Nutrition | Sports Dietetics | Protein Kinases | Aerobic Capacity | Fat Free Mass
-
NCT07252778RecruitingSupplementation | Biochemical Markers | Exercise Performance | Sports Nutrition | Aerobic Capacity
-
NCT07343518Not yet recruitingNutrition | Sports
Clinical Trials on "Prodovite®" VMP35
-
NCT04121481RecruitingAthletic Performance
-
NCT02589392CompletedAtopic Dermatitis
-
NCT01817465CompletedFunctional Dyspepsia
-
NCT00255047CompletedPertussis | Diphtheria | Polio
-
NCT02162316Unknown
-
NCT06179277CompletedPeriodontal Inflammation | Crown Lengthening
-
NCT02596009CompletedPulmonary Disease, Chronic Obstructive (COPD)
-
NCT02034708Completed