Clinical Studies
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We are building out a variety of clinical studies to evaluate the combination of health-promoting phytonutrients as found in Red Grape Cells, currently targeting the promotion of skin, eye, liver, and brain health. Too many people are taking multiple synthetic pharmaceuticals daily that are not only ineffective for their health issues, but that also cause a range of unwelcome side effects. We need to go back to medicine’s roots, literally, and study safe, effective, and affordable phytonutrients derived from plants that can combine with a sensible diet and exercise to collectively support overall health and wellness.
— Dr Brian Cornblatt, BioHarvest Chief Medical Officer
BHSC TRIALS AND STRATEGY OVERVIEW
BHSC Clinical Trials Program
1st
In vitro studies
- Determine initial biomarkers of efficacy
- Develop and support structure/function claims
- Develop scientific backing for intellectual property
2nd
Pilot Study
- Assess safety
- Confirm serving size/dosing
- Uncover in vivo biomarker changes
- Support (and possibly develop additional) structure/function claims
3rd
Publish Results in
Scientific Journal
- Use to secure additional funding:
NIH, NCI, DOD, private foundations - Differentiator – only a select few companies carry out and publish studies
- Critical for Marketing and Dr engagement
4th
Engage Pharma for partnership in larger scale trial(s)
- Engage with Pharma Companies for Funding based on Royalty Model
- Commence Pharma or grant funded larger phase 1+ randomized, placebo controlled studies
Real People Real Results Real Science
BioHarvest Sciences has created a patented platform that can isolate and elicit nature’s most powerful active ingredients, at concentrations and consistencies that open up nutraceutical and pharmaceutical possibilities.
Clinical trials are an imperative mechanism to answer efficacy and safety questions for both Health Professionals and consumers alike.
Does this product have any proof of its mechanisms of action?
Have different dosages been tested?
Is it safe?
BioHarvest has conducted multiple clinical trials for VINIA, including two human trials.
Clinical trials initiatives and pipeline
| INDICATIONS |
Preclinical Planning |
Pilot/Clinical | published / presented |
|---|---|---|---|
|
Cardiovascular |
-> |
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Type 2 Diabetes |
-> |
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Skin Health |
-> |
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Optic Neuritis (MS) |
-> |
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Glioblastoma |
-> |
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NAFLD |
-> |
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BHSC TRIALS AND STRATEGY OVERVIEW
Clinical Trial Pilot Study Milestones
Journey starts here
Initial Planning/
Market Testing
- In Market Testing (when applicable)
- Development of protocoloutline
- Initial regulatory discussions
Phase 2
Planning
- Protocol Draft
- Assembly of Items for FDA
- Onboarding research teams re: genomics and biomarkers
Phase 3
Planning
- IRB Approval
- Production & Testing of
- Study Product
- Educating & Training Research Team(s)
Study Launch
Official Accrual Begins
Study
Completion
Celebration
Pre Clinical and Clinical Trial Pipeline
For BioHarvest, we are eliciting known active ingredients and developing compositions that increase the concentrations of compounds such as Piceid resveratrol. There are many researchers studying resveratrol for its positive circulatory and anti ageing effects. We are now partnering with the global research community and are initiating a robust pipeline of Clinical Studies to test our unique red grape cell composition against specific indications, such as Multiple Sclerosis-related Optic Neuritis.
Daily consumption of red grape cell powder in a dietary dose improves cardiovascular parameters- a double-blind, placebo-controlled, randomized study
Consumption of polyphenol-rich food and food ingredient such as grape and grape products improved various cardiovascular parameters. In this study, we investigate the effect of dietary daily consumption of red grape cell powder (RGC) on blood pressure…
A novel red grape cells complex: health effects and bioavailability of natural resveratrol – PubMed
In this study, we present a novel product consisted of red grape cells (RGC) grown in culture and evaluated its effect on human LDL oxidation (in vitro) and inflammatory stress (in an in vivo rat model). We analyzed RGC for its polyphenols content and characterized RGC-derived resveratrol (RES) and …
Effect of Red Grape Cells, a High Resveratrol Polyphenols Complex, on Glycemic Control, HbA1c, and Clock Gene mRNA Expression in Type 2 Diabetes
Disrupted clock genes (CG) mRNA expression in white blood cells (WBC) is associated with T2D. Resveratrol, a natural polyphenol, exerts potent modulatory effects…
the power of piceid
Impressive solubility
Our clinical trial shows that VINIA increases the dilation of arteries by at least 70% for each person who took VINIA daily for three months.
DEEP DIVE INTO BIOAVAILABILITY
VINIA’s Piceid Resveratrol begins entering the bloodstream on average only 20 minutes after ingestion and its initial bioavailability reaches a peak blood plasma level after approximately one hour. VINIA reaches a second peak at about five hours, remaining bioactive in your blood plasma for 12 hours, which greatly enhances its beneficial effects. In comparison, poorly soluble regular Resveratrol has a single peak at 1-2 hours followed by a rapid clearing from the blood plasma.
WE TALK A BIG GAME.
WE HAVE THE DATA TO BACK IT UP.
Our test results demonstrate that VINIA® is 82% soluble compared to regular Resveratrol at 1%.
VINIA® enters the bloodstream in
20 minutes and last for 12 hours.
VINIA® has 3 peer-reviewed studies,
8 scientific studies, 14 patents.
Our test results demonstrate that 4.92mg of the 6mg of Piceid Resveratrol in each 400mg capsule is easily absorbed into the intestinal tract.
Our clinical trial demonstrates that VINIA® increases the dilation of arteries by at least 70% after 12 weeks.
Our Clinical Trial shows that VINIA increases the dilation of arteries by at least 70% for each person who took vinia daily for three months.
OUR CLINICAL TRIAL SHOWS THAT VINIA SUPPORTS BLOOD PRESSURE ALREADY WITHING NORMAL RANGE
Diastolic Blood Pressure (mm/hg)
Our Clinical Trials show that VINIA inhibits Lipid Oxidation
Inhibition of Lipid Oxidation
VINIA'S REDUCTION OF ET-1 AND INCREASE OF NITRIC OXIDE RESULTS IN AN INCREASE IN THE DILATION OF ARTERIES
Effect of VINIA on the level of endothelin-1 (ET-1) secreted by human umbilical vein endothelial cells (HUVECs)
Effect of VINIA on the expression level and activity of endothelial NO synthase (eNOS) in HUVECs
OUR CLINICAL TRIAL SHOWED THAT AFTER CONSUMING 1 GRAM OF VINIA PER DAY FOR 90 DAYS, HAB1C WAS REDUCED, AND INSULIN SENTIVITY INCREASED
HbA1c Level in Subgroup HbA1c 7.5-10.1 vs Control
Biofarmed RGC Improves Insulin Sensitivity Index Compared to Control
Clinical Trial Initiatives & API
SKIN HEALTH
(Eczema/Atopic Dermatitis, Psoriasis)
Eczema/atopic derm. – 49.4 mil.
Psoriasis – 7.5 mil.
16.8% population
MULTIPLE SCLEROSIS RELATED OPTIC NEURITIS
Cases 1,000,000
with eye health issues 700,000
.3% population
Glioblastoma
annually 10,560
Orphan Drug
.003% population
NAFLD/
Fatty Liver
cases 90,000,000 mil.
26% population
“This is a great product with a wonderful sustainability story as well. The Piceid Resveratrol combined with the full bouquet of polyphenols from grape powder, derived through this novel bio-farming process, is far superior to the normal trans-Resveratrol supplements which are solvent-derived from Polygonum. This makes VINIA simply not comparable to a standard Resveratrol supplement. As an experienced functional and integrative physician and nutritionist seeing patients with complex chronic problems, I have found VINIA to be very effective and valuable”.
Dr. David Brady
Board Certified in Functional Medicine & Clinical Nutrition
Fellow, American College of Nutrition
Member of BioHarvest Sciences Inc Scientific
Advisory Board
“Vinia’s combination of Piceid Resveratrol and other polyphenols from the red grape is scientifically proven to have optimal absorption and bioavailability resulting in vasodilatation of blood vessels. This has the effect of enhancing blood flow to tissues and organs in the body and the potential to help millions of people.”.
DENNIS GOODMAN MD
Professor of Cardiology
Board Certified Cardiologist
FACP FACC FCCP ABIHM
Member of BioHarvest Sciences Inc Scientific
Advisory BoardBoard