Effects of active hexose correlated compound on frequency of CD4+ and CD8+ T cells producing interferon-γ and/or tumor necrosis factor-α in healthy adults.

Active hexose correlated compound (AHCC) is a natural compound with the potential to be used as an immunoenhancer in cases in which the immune system is compromised. The purpose of this study was to evaluate the effects of this compound on the immune function of healthy adults aged 50 years or more. The production of interferon (IFN)-γ and tumor necrosis factor (TNF)-α by CD4(+) and CD8(+) T cells was measured by flow cytometry in peripheral blood obtained from subjects at different time points after AHCC intake. The frequency of CD4(+) and CD8(+) T cells producing IFN-γ alone, TNF-α alone, or both increased during AHCC intake compared with baseline values. Furthermore, the frequency of such cells remained high even 30 days after discontinuing AHCC. Overall, these findings suggest that AHCC enhances CD4(+) and CD8(+) T cell immune responses in healthy elderly persons taking at least 30 days to obtain such effect, which remained up to 30 days after discontinuing treatment with this compound.

A Phase I study of the safety of the nutritional supplement, active hexose correlated compound, AHCC, in healthy volunteers.

Active Hexose Correlated Compound (AHCC) is an extract of Lentinula edodes of the basidiomycete family of fungi rich in alpha glucans. AHCC has been used for many years as a dietary supplement to enhance the immune system and in clinical trials as an adjunctive treatment in Hepatocellular cancer. This multiple dose, Phase I trial, using FDA guidelines, directly investigates the clinical safety and tolerability of AHCC in healthy subjects. Its safety has been based previously on anecdotal reports and its use in clinical practice. Twenty-six healthy male or female subjects between the ages of 18 and 61 were recruited from the community and gave their consent to participate in the trial. The subjects were given 9 g of AHCC (150 mL of the currently available liquid AHCC) PO daily for 14 d. Laboratory data was obtained at baseline and after 14 d of exposure to AHCC and adverse events were monitored by a non-directed review of systems questionnaire three times during the trial. At each visit the vital signs and adverse events were recorded. Two subjects (7%) dropped out because of nausea and intolerance of the liquid. Adverse effects of nausea, diarrhea, bloating, headache, fatigue, and foot cramps occurred in a total of 6 subjects (20%) but were mild and transient. There were no laboratory abnormalities. When used in high dose in healthy subjects, AHCC causes no significant abnormality in laboratory parameters. The adverse effects of 9 g of liquid AHCC per day, a higher dose than used in routine clinical applications, are minimal and the dose was tolerated by 85% of the subjects.