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Table 6 Safety of Immunomodulatory Polysaccharide Products Following Oral Intake

From: Immunomodulatory dietary polysaccharides: a systematic review of the literature

Category Source Test group Test Design Results Equivalent human dose* Reference
Arabino-galactans Argemone mexicana (arabinogalactan protein) Pregnant rats Develop-mental toxicity 250, 500, or 1,00 mg/kg, gestational days 5-19 No developmental toxicity: NOAEL = 1 g/kg 68 g [151]
   ♀ and ♂ rats Fertility 250, 500, or 1,00 mg/kg, 1 month No effects on reproduction: NOAEL = 1 g/kg   
Fucoidans Undaria pinnatifida Rats Subchronic toxicity 1.35 g/kg, 1 month No evidence of toxicity 91.8 g [152]
Galacto-mannans Cyamopsis tetragonolobus Adolescent and adult ♂ rats Subchronic and chronic toxicity 8% of diet, 6-67 weeks No evidence of toxicity 8% of diet [153]
   Rats Acute toxicity One 7.06 g/kg dose: observed 2 weeks LD50 = 7.06 g/kg 480 g [96]
    Subchronic and chronic toxicity 1, 2, 4, 7.5 or 15% of diet, 3 months All doses ↓ ♀ BW; 7.5-15% ↓ ♂ BW; 15% ↓ bone marrow cellularity; ↓ kidney and liver weights 1-15% of diet  
   19 adults with hypercholesterol-emia   18 g/day, 1 year Short-term gastric bloating/loose stools, in 8 subjects, resolved in 7-10 days; 2 withdrew because of diarrhea. No toxicity for 13 subjects completing study 18 g [154]
   16 Type II diabetics   26.4-39.6 g/day, 6 months No effects on hematologic, hepatic, or renal function 39.9 g [155]
   18 Type II diabetics   30 g/day, 4 months   30 g  
  Cyamopsis tetragonolobus (partially hydrolyzed guar gum) Mice & rats Acute toxicity One 6 g/kg dose; observed
2 weeks
LD50 > 6 g/kg >408 g [156]
   Rats Subchronic toxicity 0.2, 1.0 or 5% of diet, 13 weeks No evidence of toxicity 5% of diet  
     0.5 or 2.5 g/kg, 1 month NOAEL > 2.5 g/kg >170 g [157]
   S. typhimurium Mutagenicity Ames test Not mutagenic NA  
Glucans Agaricus subrufescens (aqueous extract) Rats Subchronic toxicity 0.63, 1.25, 2.5 or 5% of diet, 3 months NOAEL = 5% of diet 5% of diet [158]
   3 women with advanced cancers Case reports Specific identity of products, doses, and durations of intake unknown Severe hepatotoxicity; two patients died NA [97]
  Agaricus subrufescens (freeze dried powder) 24 normal adults and 24 adults with liver problems Subchronic toxicity 3 g, 4 months No evidence of toxicity 3 g [159]
  Ganoderma lucidum
(supplement)
Elderly woman Case report 1 year G. lucidum (and another unidentified product, initiated one month previous) Elevated liver enzymes and liver tissue damage NA [98]
  Grifola frondosa (powder) Rats Acute toxicity One 2 g/kg dose No evidence of toxicity 136 g [160]
  Lentinula edodes (powder) 10 adults Safety 4 g/day for 10 weeks; repeated
3-6 months later
50% of subjects experienced blood eosinophilia, ↑ eosinophil granule proteins in serum and stool, ↑GI symptoms 4 g [99]
  Lentinula edodes
(SME)
Nude mice Safety 10% of diet days 1-18, 33-50 No adverse events 10% of diet [80]
   61 men with prostate cancer   0.1 g/kg, 6 months No adverse events 6.8 g  
  Lentinus lepideus (PG101) Female mice Subchronic toxicity 0.5 g/kg, 24 days No evidence of toxicity 34 g [92]
  Phellinus linteus
(crude extract)
Rats Acute toxicity One 5 g/kg dose; observed
2 weeks
LD50 > 5 g/kg 349 g [161]
  Pleurotus ostreatus (aqueous extract) Mice Acute toxicity One 3 g/kg dose; observed
1 day
LD50 > 3 g/kg >204.g [100]
    Subacute toxicity 319 mg/kg, 1 month Hemorrhages in intestine, liver, lung, kidney; inflammation and microabscesses in liver 21.7 g  
  Saccharomyces cerevisiae (particulate glucan [WGP]) Rats Acute toxicity One 2 g/kg, observed 2 weeks LD50 > 2 g/kg >136 g [144]
    Subchronic toxicity 2, 33.3 or 100 mg/kg, 3 months NOAEL = 100 mg/kg 6.80 g  
Heteroglycans Trametes versicolor
(PSP)
Rats Subchronic toxicity 1.5, 3.0 or 6.0 mg/kg, 2 months No evidence of toxicity 408 mg [162]
   Rats & monkeys Subchronic and chronic toxicity 100-200X equivalent human dose, 6 months No evidence of toxicity NA  
  Trametes versicolor
(PSK)
Humans with colon cancer Safety 3 g/day, up to 7 years No significant adverse events 3 g [57]
   Humans with colorectal cancer   3 g/day, 2 years   3 g [58]
Mannans Aloe vera gel Dogs Acute toxicity Fed one 32 g/kg; observed 2 weeks LD50 > 32 g/kg >2,176 g Bill Pine, personal communi-cation
   Rats   One 21.5 g/kg; observed 2 weeks LD50 > 10 g/kg >680 g  
  1. *150 lb adult