Safety and Antioxidant Activity of a Pomegranate Ellagitannin-Enriched Polyphenol Dietary Supplement in Overweight Individuals with Increased Waist Size

Abstract

The consumption of pomegranate juice (PJ), a rich source of antioxidant polyphenols, has grown tremendously due to its reported health benefits. Pomegranate extracts, which incorporate the major antioxidants found in pomegranates, namely, ellagitannins, have been developed as botanical dietary supplements to provide an alternative convenient form for consuming the bioactive polyphenols found in PJ. Despite the commercial availability of pomegranate extract dietary supplements, there have been no studies evaluating their safety in human subjects. A pomegranate ellagitannin-enriched polyphenol extract (POMx) was prepared for dietary supplement use and evaluated in two pilot clinical studies. Study 1 was designed for safety assessment in 64 overweight individuals with increased waist size. The subjects consumed either one or two POMx capsules per day providing 710 mg (435 mg of gallic acid equivalents, GAEs) or 1420 mg (870 mg of GAEs) of extracts, respectively, and placebo (0 mg of GAEs). Safety laboratory determinations, including complete blood count (CBC), chemistry, and urinalysis, were made at each of three visits. Study 2 was designed for antioxidant activity assessment in 22 overweight subjects by administration of two POMx capsules per day providing 1000 mg (610 mg of GAEs) of extract versus baseline measurements. Measurement of antioxidant activity as evidenced by thiobarbituric acid reactive substances (TBARS) in plasma were measured before and after POMx supplementation. There was evidence of antioxidant activity through a significant reduction in TBARS linked with cardiovascular disease risk. There were no serious adverse events in any subject studied at either site. These studies demonstrate the safety of a pomegranate ellagitannin-enriched polyphenol dietary supplement in humans and provide evidence of antioxidant activity in humans.

Pomegranate ellagitannins stimulate growth of gut bacteria in vitro: Implications for prebiotic and metabolic effects

“…Previous studies by our group have demonstrated that pomegranate extract is well-tolerated and without significant gastrointestinal or systemic toxicity after ingesting two 1000 mg capsules per day [15]. We also showed no difference in pharmacokinetics of plasma ellagic acid metabolites between pomegranate juice and extract [28].…”

“…The total phenolics content of the POMx and POM juice was determined using the Folin-Ciocalteau colorimetric method [14] and reported as gallic acid equivalent (GAE). The polyphenol composition of the POMx solution and POM juice was determined by HPLC as previously described [15,16].…”

Sensory Neurons and Schwann Cells Respond to Oxidative Stress by Increasing Antioxidant Defense Mechanisms

“…However, a more robust protection may result from exploiting the endogenous antioxidant response. Botanical compounds that activate Nrf2 are actively being tested for their therapeutic efficacy in other diseases involving oxidative damage, including cancer and cardiovascular disease (2,14,28,40,49,69). We recently identified a panel of compounds that prevent glucose-induced mitochondrial oxidative stress and injury in DRG neurons (78), but their effects on Nrf2 are not known.…”

Influence of oak wood polyphenols on cysteine, homocysteine and glutathione total levels and PON1 activities in human adult volunteers – a pilot study

“…Only Kannan and Quine (2011) found that pretreatment with the basic component of ellagitannins, ellagic acid, prevents isoproterenol-induced oxidative stress and decreased HCy level in myocardial infarction in rats. In a number of other human studies some positive effects were found on markers of oxidative stress (increased activity of PON1, reduced TBARP in serum, reduced 8-oxo-dG level) or on lipid profile (Aviram et al 2000;Cerdá et al 2004;Pantuck et al 2006;Heber et al 2007;Rock et al 2008;Fuhrman et al 2010;Larrosa et al 2010;López-Uriarte et al 2010). Positive effects were not observed after ellagic acid or ellagitanins supplementation on inflammatory markers (IL-6 and CRP) (Trombold et al 2010) and on cholesterol level in subjects with metabolic syndrome (Casas-Agustench et al 2010).…”