This study investigated the in vitro and in vivo antioxidant and anti-inflammatory properties of a juice blend (JB), MonaVie Active, containing a mixture of fruits and berries with known antioxidant activity, including açai, a palm fruit, as the predominant ingredient. The phytochemical antioxidants in the JB are primarily in the form of anthocyanins, predominantly cyanidin 3-rutoside, cyanidin 3-diglycoside, and cyanidin 3-glucoside. The cell-based antioxidant protection of erythrocytes (CAP-e) assay demonstrated that antioxidants in the JB penetrated and protected cells from oxidative damage (p < 0.001), whereas polymorphonuclear cells showed reduced formation of reactive oxygen species (p < 0.003) and reduced migration toward three different pro-inflammatory chemoattractants: fmlp (p < 0.001), leukotriene B4 (p < 0.05), and IL-8 (p < 0.03). A randomized, double-blinded, placebo-controlled, crossover trial with 12 healthy subjects examined the JB's antioxidant activity in vivo. Blood samples at baseline, 1 h, and 2 h following consumption of the JB or placebo were tested for antioxidant capacity using several antioxidant assays and the TBARS assay, a measure of lipid peroxidation. A within subject comparison showed an increase in serum antioxidants at 1 h (p < 0.03) and 2 h (p < 0.015), as well as inhibition of lipid peroxidation at 2 h (p < 0.01) postconsumption.

The objective of this study was to compare three tests frequently used for evaluation of antioxidant potential in natural products: (1) oxygen radical absorbance assay (ORAC), (2) cell-based antioxidant protection in an erythrocyte model (CAP-e), and (3) reactive oxygen species formation in polymorphonuclear cells (ROS PMN). The methods were applied to four natural products, all containing antioxidants capable of entering and protecting cells in the CAP-e assay. The magnitude of this effect was not directly correlated to the ORAC value of each product. Furthermore, the products showed different effects in the ROS PMN assay. Açai provided strong inhibition of ROS formation, indicating anti-inflammatory properties. In contrast, Immunel and EpiCor mildly enhanced ROS formation, suggesting activation of the innate immune response. HA Joint Formula showed a complex, nonlinear dose-response in the ROS PMN assay. This illustrates that complex natural products may have similar antioxidant properties but different effects on human cells. Cell-based antioxidant protection is addressed best in the CAP-e assay, since some natural products contain compounds that may provoke cellular signaling in other cell types. The PMN cell type is a useful model for assessment of overall anti-inflammatory versus immune supportive properties of a product. The sequential use of the three methods serves to bridge analytical and biological testing methods.

A battery of toxicological studies was conducted on a supercritical CO2 extract of the aerial parts of the Cannabis sativa plant, containing approximately 25% cannabinoids. No evidence of genotoxicity was found in a bacterial reverse mutation test (Ames), in an in vitro mammalian chromosomal aberration test, or in an in vivo mouse micronucleus study. A 14-day repeated oral dose-range finding study conducted in Wistar rats at 1000, 2000, and 4000 mg/kg bw/day resulted in effects where a NOAEL could not be concluded. Based on those results, a 90-day repeated dose oral toxicity study was performed in rats using doses of 100, 360, and 720 mg/kg bw/day, followed by a 28-day recovery period for two satellite groups. Significant decreases in body weight, body weight gain, and differences in various organ weights compared to controls were observed. At the end of the recovery period, many of the findings were trending toward normal; thus, the changes appeared to be reversible. The NOAEL for the hemp extract in Hsd.Han Wistar rats was considered to be 100 mg/kg bw/day for males and 360 mg/kg bw/day for females.

It has been demonstrated that some strains of Bacillus coagulans can survive extremes of heat, acidity of the stomach, and bile acids, to which commonly consumed probiotics are susceptible. A toxicological safety assessment was performed on a proprietary preparation of B. coagulans – GanedenBC30™ – a novel probiotic. Seven toxicologic studies were conducted and included: in vitro bacterial reverse mutation assay; in vitro chromosomal aberration assay; micronucleus assay in mice; acute and 90 day subchronic repeated oral toxicity studies were conducted in Wistar Crl:(WI) BR rats; acute eye and skin irritation studies were conducted in rabbits.The results of this toxicological safety assessment indicate that GanedenBC30™B. coagulans does not demonstrate mutagenic, clastogenic, or genotoxic effects. Furthermore, the results of the acute and 90-day subchronic oral toxicity studies in rats resulted in the conclusion of a NOAEL greater than 1000 mg/kg per day. Since the concentration of the cell mass used in the 90-day study was 1.36 × 1011 CFUs/g, this corresponds to 95.2 × 1011 CFUs for a 70 kg human and since the suggested human dose is in the range of 100 × 106 to 3 × 109 CFUs, this gives a safety factor ranging from 3173 to 95,200 times. Based upon scientific procedures and supported by history of use, GanedenBC30™ is considered safe for chronic human consumption.