Safety and Efficacy of two dietary supplements, Immuno-Viva™ and Immune Lift™ used as Free Radical Scavengers in Healthy Subjects.

Abstract

Chronic vascular disease among other things is linked to systemic stress, production of free radicals, and a reduced antioxidant defense that may ultimately lead to tissue damage and related cardiovascular complications. Administration of dietary supplements with antioxidant properties have shown to be beneficial in protecting against free radical effects. Immuno-Viva™, a blend of cold pressed pure, black raspberry and black cumin seed oils meeting FDA DSHEA Regulations, has shown significant free radical scavenging properties in preliminary animal studies; however, supportive evidence using controlled clinical trials are not yet available. Immune Lift™, a powder product from the cold press procedure containing black raspberry and black cumin, has not been studied extensively. The components of the two products are generally accepted as safe food ingredients or have been evaluated in animal models; however, no safety data on the final product formulations are available. The primary aim of this study is to examine product safety in respect to maintained normal liver and kidney functions in healthy participants. Levels of ALT, AST and creatinine were measured. Secondary aims included evaluating possible effects of these oils on free radical levels immune response mechanisms. Total blood counts and lymphocyte fractions as well as malondialdehyde in urine were measured. The study involved 30 participants consuming 3 teaspoons (15 g) of Immuno-Viva™ daily for one month, and an additional 2 tablets of Immune Lift™ for one additional month. Measurements and blood sampling was conducted on days 0, 30 and 60. The design is pre and post oil effects. The hypothesis is that Immuno-Viva™ and Immune Lift™ will have no adverse effects on normal liver and kidney functions and support the immune response mechanisms to control free radical effects.