Athletic PerformanceVMP35SportNCT04121481
Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance
A study testing Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement and Broad Spectrum Safety in people with Athletic Performance, run by Victory Nutrition International, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance
- What is being tested?
- Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement and Broad Spectrum Safety
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 30 Sep 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
- AND
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
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Champions Sports Performance & Hardcore Serious Fitness
Cornelius, North Carolina, 28031
Greg O'Connor, MS, 704-439-1111, greg@championssportsperformance.com
Bear Robinson, MS, (704)301-5932, hardcoreseriousfitness@gmail.com
About this study
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.
Read the detailed description
A novel patented Prodovite® VMP35 Multi-Nutrient-Complex (MNC), a vitamin, mineral, and phytonutrient encapsulated liquid formulation, was prepared using a novel proprietary SK713 SLP multi-lamellar clustoidal non-GMO phospholipid Prodosome 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. We hypothesize that Prodovite® VMP35 supplement will enhance athletic performance, lean-body muscle mass, increase exercise tolerance, and improve anabolic parameters in healthy human subjects. The aim of this pilot study is to evaluate the effect of oral supplementation of Prodovite® VMP35 on exercise endurance, muscle strength, anabolic parameters and lean body mass in healthy human subjects. We hypothesize that Prodovite® VMP35 supplementation will enhance and increase exercise performance, tolerance, lean-body muscle mass, improve anabolic parameters and 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.
- Conditions
- Athletic Performance
- Being tested
- Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement, Broad Spectrum Safety
- Keywords
- Prodovite VMP35; RCT; Athletic Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 SupplementDietary supplement
Also called Physical Well Being, Health Status, Detailed Lipid Profile and Blood Chemistry Analysis; Adverse Event Monitoring; Compliance
Assess the Sports Nutrition efficacy of Prodovite VMP35 against the Placebo sample
Broad Spectrum SafetyDietary supplement
Also called Sports Nutrition and Health Staus
Benefits in Sports Nutrition
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Approximately a total of 75 participants will be assigned in the Placebo Group (two divided doses will be given) Receives: Dietary Supplement: Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement; Dietary Supplement: Broad Spectrum Safety |
| Treatment Group | Active comparator | 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 Receives: Dietary Supplement: Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement; Dietary Supplement: Broad Spectrum Safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric Measurements: Body Weight
Body Weight (Kilograms)
Measured: Over a Period of 90-Consecutive Days
Anthropometric Measurements: Height
Height (Meters)
Measured: Over a Period of 90-Consecutive Days
Anthropometric Measurements: Waist Circumference
Waist Circumference (Meters)
Measured: Over a Period of 90-Consecutive Days
Anthropometric Measurements: Waist-Hip Ratio
Waist : Hip Ratio
Measured: Over a Period of 90-Consecutive Days
Anthropometric Measurements: Blood Pressure (mmHg)
Blood Pressure (mmHg)
Measured: Over a Period of 90-Consecutive Days
Body Composition and Bone Mineral Density: DEXA (GE)
DEXA and Bone Mineral Density
Measured: Over a Period of 90-Consecutive Days
Ergometric Assessment: Treadmill
Ergometric measurements
Measured: Over a Period of 90-Consecutive Days
Handgrip Dynamometer
Handgrip strength
Measured: Over a Period of 90-Consecutive Days
Respiration Quality and Rate: Spirometer
Respiration Quality, VO2 and VCO2 assessments
Measured: Over a Period of 90-Consecutive Days
Endurance Studies
Cycle Ergometer, Bench Press and Leg Press
Measured: Over a Period of 90 Consecutive Days
Secondary outcomes (2)
Lipid Profile
Complete Lipid Profile
Measured: Over a Period of 90-Consecutive Days
Total Blood Chemistry
Blood Chemistry
Measured: Over a 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 posted10 Oct 2019
- Study start15 May 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion30 Sep 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 Athletic PerformanceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The aim of this pilot study is to evaluate the effect of oral supplementation of Prodovite® VMP35 on exercise endurance, muscle strength, anabolic parameters and lean body mass in healthy human subjects. We hypothesize that Prodovite® VMP35 supplementation will enhance and increase exercise performance, tolerance, lean-body muscle mass, improve anabolic parameters and 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.
- Masking
- Single blind
- Who is masked
- Participant
- 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, SPORTS NUTRITION & FAMILY MEDICINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121481
- Sponsor's protocol ID
- VNI-VMP35-SPORTS-OCT 2019
- Acronym
- VMP35Sport
- Status last verified
- May 2021
- First submitted
- 3 Oct 2019
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IT IS A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY
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 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance
- ClinicalTrials.gov ID
- NCT04121481
- Acronym / sponsor ID
- VMP35Sport / VNI-VMP35-SPORTS-OCT 2019
- Conditions
- Athletic Performance
- Keywords
- Prodovite VMP35; RCT; Athletic Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Victory Nutrition International, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 May 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 10 Oct 2019 (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.
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.
Detailed description
A novel patented Prodovite® VMP35 Multi-Nutrient-Complex (MNC), a vitamin, mineral, and phytonutrient encapsulated liquid formulation, was prepared using a novel proprietary SK713 SLP multi-lamellar clustoidal non-GMO phospholipid Prodosome 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. We hypothesize that Prodovite® VMP35 supplement will enhance athletic performance, lean-body muscle mass, increase exercise tolerance, and improve anabolic parameters in healthy human subjects. The aim of this pilot study is to evaluate the effect of oral supplementation of Prodovite® VMP35 on exercise endurance, muscle strength, anabolic parameters and lean body mass in healthy human subjects. We hypothesize that Prodovite® VMP35 supplementation will enhance and increase exercise performance, tolerance, lean-body muscle mass, improve anabolic parameters and 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The aim of this pilot study is to evaluate the effect of oral supplementation of Prodovite® VMP35 on exercise endurance, muscle strength, anabolic parameters and lean body mass in healthy human subjects. We hypothesize that Prodovite® VMP35 supplementation will enhance and increase exercise performance, tolerance, lean-body muscle mass, improve anabolic parameters and 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement, Dietary Supplement: Broad Spectrum SafetyApproximately a total of 75 participants will be assigned in the Placebo Group (two divided doses will be given) |
| Treatment Group | Active comparator | Dietary Supplement: Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement, Dietary Supplement: Broad Spectrum SafetyApproximately 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 |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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
- AND
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 |
|---|---|---|
| Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 SupplementAlso: Physical Well Being, Health Status, Detailed Lipid Profile and Blood Chemistry Analysis; Adverse Event Monitoring; ComplianceAssess the Sports Nutrition efficacy of Prodovite VMP35 against the Placebo sample | Dietary supplement | Placebo, Treatment Group |
| Broad Spectrum SafetyAlso: Sports Nutrition and Health StausBenefits in Sports Nutrition | Dietary supplement | Placebo, Treatment Group |
Primary outcome
Anthropometric Measurements: Body Weight
Time frame: Over a Period of 90-Consecutive Days
Body Weight (Kilograms)
Anthropometric Measurements: Height
Time frame: Over a Period of 90-Consecutive Days
Height (Meters)
Anthropometric Measurements: Waist Circumference
Time frame: Over a Period of 90-Consecutive Days
Waist Circumference (Meters)
Anthropometric Measurements: Waist-Hip Ratio
Time frame: Over a Period of 90-Consecutive Days
Waist : Hip Ratio
Anthropometric Measurements: Blood Pressure (mmHg)
Time frame: Over a Period of 90-Consecutive Days
Blood Pressure (mmHg)
Body Composition and Bone Mineral Density: DEXA (GE)
Time frame: Over a Period of 90-Consecutive Days
DEXA and Bone Mineral Density
Ergometric Assessment: Treadmill
Time frame: Over a Period of 90-Consecutive Days
Ergometric measurements
Handgrip Dynamometer
Time frame: Over a Period of 90-Consecutive Days
Handgrip strength
Respiration Quality and Rate: Spirometer
Time frame: Over a Period of 90-Consecutive Days
Respiration Quality, VO2 and VCO2 assessments
Endurance Studies
Time frame: Over a Period of 90 Consecutive Days
Cycle Ergometer, Bench Press and Leg Press
2 secondary outcomes
Lipid Profile
Time frame: Over a Period of 90-Consecutive Days
Total Blood Chemistry
Time frame: Over a 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 7 May 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. IT IS A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY
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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
SPORTS NUTRITION & FAMILY MEDICINE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement and Broad Spectrum Safety in people with Athletic Performance, run by Victory Nutrition International, Inc. at 1 site 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 5 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 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 DEBASIS BAGCHI, PhD ((925)948-6951, debasisbagchi@gmail.com; debasis@vni.life), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric Measurements: Body Weight (time frame: Over a Period of 90-Consecutive Days). The study lists 10 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 NCT04121481, 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 7 May 2021.