Latest Research Developments

08/24/10: Health Benefits from Tea: Perception vs. Reality

WellGen’s own Dr. Shiming Li presented research about the analytical method for measuring polyphenols and the polyphenol content in ready-to-drink tea beverages at the American Chemical Society (ACS) meeting that began August 22 [...]

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Clinical Studies

The final stage in the WellGen research process is to conduct human studies to confirm whether the bioactive substance favorably impacts the health condition toward which it is directed. Human studies are designed to incorporate endpoints appropriate for future labeling, marketing and regulatory needs. In the clinical development process, WellGen uses biomarkers, validated and predictive biological indicators, to aid in the evaluation of the actions of promising products in humans. The use of biomarkers to measure physiological effects has been recommended by the U.S. Food and Drug Administration (FDA). Human studies are designed to measure effects of test substances on select, validated biomarkers.

External experts advise on study design to insure acceptance of the scientific value of the study and conformation with data needed to support regulatory and customer needs.  In addition, sensory/perceptual outcome measures with direct relevance to subsequent product positioning and claims are included, such as ‘delayed onset muscle soreness’. This approach helps direct application of study results to business development strategies.

Given the strong scientific foundation, and the rigorous clinical development approach, we believe that WellGen products will be far more effective than most natural products on the market today which have not been subjected to the same level of in vitro, in vivo and clinical study as WellGen’s products.

Clinical support for WellGen® theaflavin- rich black tea concentrate:

Human Clinical Study 1:

Systemic Inflammation Study LPS (lipopolysaccharide)- mediated challenge exposes the inflammation cascade and is a fundamental pharmaceutical inflammation probe.

Key findings

  • Reduces expression of pro-inflammatory mRNA and cytokines/chemokines proteins
  • Inflammatory biomarker levels ranging between two-to-four fold less than the placebo group
  • Elevation of immuno-modulatory cytokine IL-10

Human Clinical Study 2:

Exercise-induced Inflammation - Test the effects in high-intensity anaerobic exercise on:

  • Delayed onset muscle soreness (DOMS)
  • Oxidative stress
  • Cortisol response
  • Inflammatory biomarkers

Key findings

  • Reduces damage and inflammation due to exercise related stress
  • Promotes rapid post-exercise recovery
  • Improves capacity to exercise
  • Reduces oxidative stress markers
  • Relieves delayed onset muscle soreness due

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