Safety evaluation of an açai-fortified fruit and berry functional juice beverage (MonaVie Active®)

Alexander G. Schauss, Amy Clewell, Lajos Balogh, Ilona Pasics Szakonyi, Istvan Financsek, János Horváth, Julianna Thuroczy, Erzsébet Béres, Adél Vértesi, Gabor Hirka

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21 Citations (Scopus)

Abstract

The safety of an açai (Euterpe oleracea Mart.) pulp enriched fruit and berry juice, MonaVie Active®, fortified with the functional ingredient, glucosamine, was studied. The beverage was found not to be mutagenic, clastogenic, cytotoxic, or genotoxic, as determined by the bacterial reverse mutation assay, chromosomal aberration assay, mouse micronucleus assay, and mammalian cell gene mutation (L5178Y) assay. The single dose LD50 based on a 14-day acute oral toxicity study is greater than 20,000mg/kgbw, the highest dose tested. In a repeat dose 90-day oral subchronic toxicity study by gavage, 220 animals were randomly assigned to a control group, an untreated group, or one of three experimental groups (10, 20 and 40g/kgbw). No treatment-related significant changes in body weight, food and water consumption, ophthalmology, organ weights, urinanalysis, hematological and clinical chemistry, or gross pathology, were observed in surviving animals compared to the control groups. Three animals died midway through the observation period (male, 20g/kgbw/day; male 40g/kgbw/day; and, female, 10g/kgbw/day). These animals died without preceding clinical symptoms, histopathological lesions, or evidence of injury to tissue or organs except for signs of suffocation/aspiration congestion, which was concluded to be due to problems with the gavage administration of the fluid test article, and not due to the test article itself. The NOEAL was determined to be 40g/kgbw/day for male and female rats, which was the highest dose tested. Phylloquinone (vitamin K1) content averaged 21.7μg/100g, comparable to amounts found in iceberg lettuce. In conclusion, the results provide additional experimental evidence that MonaVie Active® juice is non-toxic.

Original languageEnglish
Pages (from-to)46-54
Number of pages9
JournalToxicology
Volume278
Issue number1
DOIs
Publication statusPublished - Nov 28 2010

Keywords

  • Acute toxicity
  • Açai
  • Euterpe oleracea
  • Functional food
  • Genotoxicity studies
  • Phylloquinone (vitamin K1)
  • Subchronic toxicity

ASJC Scopus subject areas

  • Toxicology

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  • Cite this

    Schauss, A. G., Clewell, A., Balogh, L., Szakonyi, I. P., Financsek, I., Horváth, J., Thuroczy, J., Béres, E., Vértesi, A., & Hirka, G. (2010). Safety evaluation of an açai-fortified fruit and berry functional juice beverage (MonaVie Active®). Toxicology, 278(1), 46-54. https://doi.org/10.1016/j.tox.2010.04.017