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 |