Subchronic 90-day oral (Gavage) toxicity study of a Luo Han Guo mogroside extract in dogs

Department of Pharmacology, Pharmaceutical Institute of Guilin Medical College, Guilin, Guangxi, People's Republic of China.
Food and Chemical Toxicology (Impact Factor: 2.9). 01/2007; 44(12):2106-9. DOI: 10.1016/j.fct.2006.07.023
Source: PubMed


A combined 28-day and 90-day oral (Gavage) study was conducted in male and female dogs to investigate the safety of PureLo, a non-caloric sweetener derived from the Chinese fruit Luo Han Guo, which achieves its sweetness from the presence of triterpene glycosides known as mogrosides. Three dogs of each sex were administered 10 mL/kg bw/day of either an aqueous solution providing 3000 mg/kg bw/day of PureLo or distilled water for either 28 days or 90 days. Measurements included clinical observations, body weight, food consumption, hematology, blood chemistry, urinalysis, gross necropsy, organ weight, and histopathology. There were no significant adverse effects on any of these measures. Based on the lack of toxicological effects in the study, the NOAEL for PureLo is 3000 mg/kg bw/day when administered to dogs by Gavage for 90 consecutive days.

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    • "The primary active components of Luohanguo are the mogrosides, a group of terpene glycosides that are estimated to be about 300 times as sweet as sucrose (Kasai et al., 1989). The mogrosides produce a sweet taste in Chinese herbal Kombucha prepared using Luohango extracts and have been approved for use as dietary supplements in Japan, the United States, New Zealand and Australia (Qin et al., 2006). Chrysanthemum and green tea contain effective antiviral compounds such as chlorogenic acid and various polyphenolics, which can inhibit the reproduction of HIV, HBV, and the influenza virus, among others (Imanishi et al., 2002;Nakayama et al., 1993;Xu et al., 2008). "
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    ABSTRACT: The foot and mouth disease virus (FMDV) is sensitive to acids and can be inactivated by exposure to low pH conditions. Spraying animals at risk of infection with suspensions of acid-forming microorganisms has been identified as a potential strategy for preventing FMD. Kombucha is one of the most strongly acid-forming symbiotic probiotics and could thus be an effective agent with which to implement this strategy. Moreover, certain Chinese herbal extracts are known to have broad-spectrum antiviral effects. Chinese herbal kombucha can be prepared by fermenting Chinese herbal extracts with a kombucha culture. Previous studies demonstrated that Chinese herbal kombucha prepared in this way efficiently inhibits FMDV replication in vitro. To assess the inhibitory effects of Chinese herbal kombucha against FMDV in vitro, swine challenged by intramuscular injection with 1000 SID50 of swine FMDV serotype O strain O/China/99 after treatment with Chinese herbal kombucha were partially protected against infection, as demonstrated by a lack of clinical symptoms and qRT-PCR analysis. In a large scale field trial, spraying cattle in an FMD outbreak zone with kombucha protected against infection. Chinese herbal kombucha may be a useful probiotic agent for managing FMD outbreaks.
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    • "Its non-caloric properties and effects on the cancer chemopreventive and antioxidant, being used as sweetening are being used as sweetening agents for the patients with diabetes mellitus, adiposis, hypertension, heart disease and so on. Luohanguo products have been approved as dietary supplements in Japan, the United States, New Zealand and Australia [4]. With the rapid rise in market demand, Luohanguo extracts have increased rapidly from two tons in 2002 to 60┬átons in 2007, becoming one of the fastest growing traditional Chinese medicine extracts. "
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    ABSTRACT: A 28-day dietary study was conducted in Hsd:SD rats to evaluate the safety of PureLo, a non-caloric powdered concentrate of the Chinese fruit Luo Han Guo, which derives its sweetening properties from triterpene glycosides called mogrosides. Groups of 20 rats (10/sex/group) were fed diets containing 0, 10,000, 30,000, or 100,000 ppm PureLo for 28 days (OECD, Redbook 2000). PureLo was well tolerated and produced no significant adverse effects. Reduced body weight and body weight gain in high-dose animals of both sexes were related to sporadic reductions in food consumption; there were no overall differences in feed efficiency. Statistically significant changes in clinical chemistry (decreased bilirubin, increased total protein) and relative organ weights of liver, adrenals, ovaries and/or testes, and epididymides were not correlated with any histopathological findings and were not considered adverse. Although a few clinical and pathological findings suggest possible treatment-related effects, particularly in the high-dose group, these findings were transient, not dose-dependent, non-adverse, inconsistent, occurred only in one sex, and/or not supported by histopathological findings. Under the conditions of this study and based on the toxicological endpoints evaluated, the NOAEL for PureLo was 100,000 ppm in the diet, the highest level tested, equivalent to 7.07 and 7.48 g/kg bw/day for male and female rats, respectively.
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