Safety of a Novel Calcium/Potassium Salt of Hydroxycitric Acid (HCA-SX): I. Two-Generation Reproduction Toxicity Study

ABSTRACT

(-)-Hydroxycitric acid (HCA), a natural plant extract from the dried fruit rind of Garcinia cambogia, has been reported to inhibit fat synthesis and reduce food intake. The objective of this study was to evaluate the effects of a novel calcium/potassium salt of (-)-hydroxycitric acid (HCA-SX) on the reproductive systems of male and female rats, the postnatal maturation and reproductive capacity of their offspring, and possible cumulative effects through multiple generations. Sprague-Dawley rats (30/sex/group) were maintained on feed containing HCA-SX at dose levels of 0, 1000, 3000, or 10,000 ppm for 10 weeks prior to mating, during mating, and, for females, through gestation and lactation, across two generations. During the period of study, animals were examined daily for signs of clinical toxicity and their body weight and feed consumption were recorded twice a week. For the parents (F₀ and F₁) and the offspring (F₁ and F_2a), reproductive parameters such as fertility and mating, gestation, parturition, litters, lactation, sexual maturity, and development of offspring were assessed. At termination, necropsy and histopathological examinations were performed on all animals. Dietary exposure of HCA-SX to parental male and female rats of both (F₀ and F₁) the generations during the premating and mating periods, for both sexes, and during gestation and lactation in case of female rats, did not reveal any remarkable incidence of mortality or abnormal clinical signs. Compared to respective controls, HCA-SX exposure did not affect feed consumption or body weight at any of the exposure levels. HCA-SX exposure did not affect reproductive performance as evaluated by sexual maturity, fertility and mating, gestation, parturition, litter properties, lactation, and development of the offspring. Based on the results of this study, the parental as well as the offspring no-observed-adverse-effect level for HCA-SX was determined to be greater than 10,000 ppm in diet or equivalent to 1018 and 1524 mg/kg body weight/day in male and female rats, respectively.

KEYWORDS :

• Hydroxycitric Acid
• Garcinia cambogia Extract
• Fertility
• Gestation
• Lactation
• Reproductive Toxicity
• Safety

ABBREVIATIONS
FDA	=	Food and Drug Administration;
HCA	=	(-)-Hydroxycitric acid;
NOAEL	=	no-observed-adverse-effect level;
NOEL	=	no-observed-effect level;
ADI	=	Acceptable Daily Intake;
OECD	=	Organization for Economic Co-operation and Development;
DSHEA	=	Dietary Supplement Health and Education Act.

ABBREVIATIONS
FDA	=	Food and Drug Administration;
HCA	=	(-)-Hydroxycitric acid;
NOAEL	=	no-observed-adverse-effect level;
NOEL	=	no-observed-effect level;
ADI	=	Acceptable Daily Intake;
OECD	=	Organization for Economic Co-operation and Development;
DSHEA	=	Dietary Supplement Health and Education Act.