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Clinical Results
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Clinical information and what it means



Completed

We recently announced the positive results from the anti-ageing study using our Phytofare™ Catechin Complex in a Pheroid® formulation which will be sold under the ph²™ brand.
The results proved that the ph²™ catechin complex statistically and significantly reduced the signs of ageing in the three of the four areas tested:

  • Skin hydration – 15.2% increase as compared to the baseline
  • Skin roughness – 14.6% decrease as compared to the baseline
  • Skin scaliness – 20.4% reduction as compared to the baseline

The results for Skin elasticity were not statistically significant.  In the case of collagen production, this can take three months or longer before this remodelled tissue reaches the surface and becomes visible.  It is therefore not surprising that the study’s results were not statistically significant. Given time (3+ months) we believe that a similar statistical difference, as per the other tested parameters, would be apparent.

To put these results into context we did a comparative review of our Phytofare™ Catechin Complex against a previous green tea study sponsored by NuSkin.

A study published in 2005 in volume 31 of Dermatologic Surgery and sponsored by Nu Skin International addressed the positive histological and clinical effects that green tea in a topical formulation has on characteristics of photoaging.  The study focused on fine wrinkling, tactile roughness, visual dryness, and skin laxity/tone.  The eight-week study concluded that histologic grading found improvement; however, clinically significant changes could not be visually observed, suggesting that visible improvements in the skin may take longer supplementation to achieve. What this means in simple terms is that while structural improvements were noted, these changes were not visibly apparent on the surface of the skin.
When you compare our results to this study what you find is that we not only validate what the NuSkin study proved, histologically, but we go a step further and prove statistically and significantly that Plandaí’s Phytofare™ Catechin Complex also delivers visible anti-aging benefits in only six weeks.
What we have done is demonstrate that Phytofare™, which is a highly bioavailable version of green tea catechins, has superior anti-oxidant absorption.  This means that we can generate both noticeable and histologic results, yielding immediate and long-term anti-aging benefits.

Current clinical trial

  • Human bioavailability study utilizing Phytofare™ Catechin Complex

This study will test the level of absorption of Phytofare™ when taken orally and then compare these results against a standard green tea extract.  We expect to show that our formulation, in both Pheroid® and non-Pheroid® versions has significantly higher bioavailability, which will open the door to a host of potential pharmaceutical and nutriceutical applications for Phytofare™.

Green tea, along with many other plants, has tremendous medical potential, but this potential remains largely untapped as catechins (the active chemicals in green tea) have very poor bioavailability (absorption).  By increasing the bioavailability, we hope to create a product that can replicate in humans the results obtained in laboratory studies.  Our extraction process, combined with Pheroid® entrapment, is designed to make plant nutrients biocompatible with human tissue. We should be able to deliver high dosages of plant nutrients at a fraction of the cost, allowing us for the first time to look at natural ingredients as a potential solution to various health and wellness targets. 

This bioavailability study is the final step in validating our technology—not only for green tea, but also for the other natural ingredients science has identified and potentially beneficial.

Pipeline
Once we have the bioavailability results in hand, we plan to immediately commence a series of human clinical trials designed to test for specific conditions.  First on the list are the two studies which feature our initial flagship product offerings:

  • Human weight-loss study utilizing Phytofare™ Catechin Complex
  • Cold and flu study utilizing Phytofare™ Citrus Bioflavonoid Complex

Green tea has been long known to be effective in promoting weight loss by inducing thermogenesis. Unfortunately, with poor bioavailability, the level of consumption needed (800mg) to generate significant results can also lead to side effects including nausea.  Phytofare™ Catechin Complex entrapped in Pheroid® (Ph2™) should allow us to deliver a high dose of green tea catechins without the side effects.  Initial anecdotal indications are very favourable, but a full-scale clinical trial should validate the product as a highly effective weight loss supplement.

Our Phytofare™ Citrus Bioflavonoid Complex is made from lemons and incorporates the entire chemical bioflavonoid profile.  Third party studies have shown that a high-dose citrus complex is effective in treating cold and flu symptoms, so Plandai intends to test its product in a full-scale human clinical trial that should get underway this winter season.  If successful, we will immediately begin full-scale production of our Phytofare™ Citrus Bioflavonoid Complex and also commence further studies testing the product’s anti-inflammatory properties for sports injuries and exercise recovery—both areas that have responded favourably in earlier citrus trials. 

As you can see from this brief overview, Plandai is committed to further research as we look for ways to improve health and wellness through all-natural products.  Nature has given us everything we need—we just need to unlock the secrets.

 

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