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

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vitaminology." href="AL_get(this,%20'jour',%20'J%20Nutr%20Sci%20Vitaminol%20(Tokyo).');">J Nutr Sci Vitaminol (Tokyo).
2007 Dec;53(6):536-9.
A
Phase I study of the safety of the nutritional supplement, active
hexose correlated compound, AHCC, in healthy volunteers.

Spierings
EL
, Fujii
H
, Sun
B
, Walshe
T
.
Medvadis Research Corporation, Wellesley
Hills, Massachusetts, USA.

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.