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Safety
Super CitriMax® Safety Overview
Super CitriMax®, a novel calcium/potassium (–)-hydroxycitric acid (HCA) extract, has previously been reported to help control appetite and body weight in animals and humans.
While the mechanisms of action are not fully defined, HCA has been shown to competitively inhibit the enzyme ATP citrate lyase necessary for fat synthesis, while Super CitriMax® has been shown to promote fat oxidation (the burning of fat) and raise levels of brain serotonin, a neurotransmitter involved in appetite suppression.
This paper highlights experiments conducted to assess acute and longer-term safety of Super CitriMax®. In acute oral and dermal (skin), as well as dermal and eye irritation tests, Super CitriMax®Max® demonstrated a wide margin of safety.
Super CitriMax® did not induce mutagenic effects in bacterial strains, nor in the cell gene mutation test using mouse lymphoma cells.
The effects of Super CitriMax® on body weight and safety parameters were evaluated in Sprague-Dawley rats fed varying concentrations (0.2, 2.0, and 5.0%) of HCA in standard chow over a 90-day period. The lowest concentration (0.2%) corresponds to the daily dose of Super CitriMax®Max® (2,772 mg HCA) used in human trials.
Compared to controls, an expected significant decrease in body weight was observed in Super CitriMax®-fed animals.
No significant differences between the two groups were seen when selected organ weights were measured individually or as a % of body or brain weight. The results of DNA fragmentation and lipid peroxidation measurements in the liver and testis indicate that Super CitriMax® did not damage genetic material or lipids (fats) in these tissues.
In summary, feeding Super CitriMax® at concentrations equivalent to the recommended human dose (0.2%) and 10-25 fold higher than the recommended dose (2 and 5%) resulted in lower body weight, but did not cause any changes in major organs, blood or clinical chemistry or histopathology.
Taken together, these results support the safe use of Super CitriMax® as a dietary supplement for weight management.
Super CitriMax® Demonstrates Safety at Levels Used in Clinical Trials
The dried fruit rind of Garcinia cambogia is a unique source of (–)-hydroxycitric acid (HCA) that has been safely consumed for centuries in Southeast Asia to make meals more “filling.”
Super CitriMax® is a highly bioavailable extract of Garcinia that has previously been shown to help control appetite and body weight in animals and humans.
The results of earlier acute oral and dermal (skin) toxicity studies demonstrate the safety of Super CitriMax®.
To assess the longer-term safety of HCA at levels that reflect or exceed an established dose for humans, a battery of standard animal tests was conducted.
The dried fruit rind of Garcinia cambogia is a unique source of (–)-hydroxycitric acid (HCA) that has been safely consumed for centuries in Southeast Asia to make meals more “filling.” Super CitriMax® is a highly bioavailable extract of Garcinia that has previously been shown to help control appetite and body weight in animals and humans.
The results of earlier acute oral and dermal (skin) toxicity studies demonstrate the safety of Super CitriMax®.
To assess the longer-term safety of HCA at levels that reflect or exceed an established dose for humans, a battery of standard animal tests was conducted. Sprague-Dawley rats were fed Super CitriMax® at varying concentrations of their food intake (0.2, 2.0 and 5.0%) over a 90 day periods. The lowest concentration, 0.2%, corresponds to the daily dose of Super CitriMax®Max® (2,772 mg HCA) used in human trials evaluating its effect on weight reduction. The higher concentrations (2.0 and 5.0%) represent doses 10 and 25 times greater.
A significantly greater reduction in body weight was seen in the Super CitriMax® supplemented animals compared to controls, while no significant differences in organ weights or histopathological (microscopic) changes in vital organs were observed at any of the HCA levels fed.
Similarly, no differences were noted in blood and clinical chemistries between the groups.
The results of DNA fragmentation and lipid peroxidation measurements in the liver and testis indicate that Super CitriMax® does not damage genetic material or cellular lipids (fats) in these tissues. The safety parameters assessed in this and prior studies support the use of supplemental Super CitriMax®Max® as a safe dietary aid forweight management at a clinically effective doses.
ChromeMate® Found Safe in a Broad Range of Toxicity Tests
ChromeMate® is a niacin-bound form of chromium that promotes normal insulin function.
To determine the safety of ChromeMate®, a wide range of standard toxicity studies were conducted.
In acute oral testing, the LD50 of ChromeMate® in male and female rats was found to be greater than 5,000 milligrams per kilogram (mg/kg) of body weight.
The acute dermal LD50, determined by exposing the test animal’s skin to ChromeMate®, was higher than 2,000 mg/kg.
Both acute oral and skin LD50 values are relatively high, indicating that the ability of ChromeMate® to cause harm when exposed to a single high dose is relatively low.
Additionally, ChromeMate® was only slightly irritating to the skin and practically non-irritating to the eye. ChromeMate® did not cause any genetic changes when tested for mutagenic effects in five bacterial strains and in mouse lymphoma cells.
Blood, clinical chemistry and microscopic tissue evaluations did not show any adverse effects in organs after a 90 day sub-chronic toxicity study of ChromeMate® administered in increasing doses.
ChromeMate® did not damage lipids in the liver or cause fragmentation of DNA over the course of the sub-acute study.
These results from a wide array of toxicity testing, demonstrate and support the broad spectrum safety of ChromeMate®.
Super CitriMax® Safety Affirmed in Research Review
Super CitriMax®, a novel calcium/potassium (–)-hydroxycitric acid (HCA) extract, has been shown to inhibit body fat production and reduce food intake in laboratory studies, and to help control weight in human studies.
The present paper offers a comprehensive review of the published literature related to the safety of HCA and Super CitriMax®.
The dried fruit rind of Garcinia cambogia is a rich source of HCA, and has been used for centuries as a spice, flavor-enhancer, preservative and digestive aid throughout Southeast Asia.
Thus, it has a long history of consumption in countries where the plant is native. Structurally, HCA is similar to the common food additive citric acid, which also occurs naturally in citrus fruits such as oranges and lemons. The high bioavailability of HCA from Super CitriMax® (60% HCA) has been demonstrated in humans.
A primary mode of HCA action appears to be its ability to inhibit ATP-citrate lyase, an enzyme that helps to form the building blocks of fatty acids and cholesterol.
Acute toxicity studies of CitriMax® (50% HCA) in animals demonstrate that it is virtually non-toxic.
In a sub-chronic animal study, daily doses up to 2,500 mg per kg body weight (equivalent to 150,000 mg for a 132 lb. person) for 3 months reduced body weight and feed consumption without any adverse effects.
Toxicity studies, as well as the structure of HCA, its mechanism of action and its historical use, indicate that Super CitriMax® is unlikely to cause reproductive developmental effects or genetic mutations.
No treatment-related adverse effects were reported from 14 controlled trials administering up to 2,800 mg HCA daily to volunteers for up to 90 days.
The reviewers conclude that the quantity and quality of scientific evidence is sufficient to support the safe, supplemental use of HCA at levels up to 2,800 mg daily (4,667 mg of Super CitriMax®).
Super CitriMax® Demonstrates Long-Term Safety and Weight Reduction in Animals
Super CitriMax®, an extract of Garcinia cambogia containing 60% (–)hydroxycitric acid, has been previously shown to effectively aid weight management in human subjects.
The historical use of this dried fruit rind as a condiment in Southeastern Asia, as well as the results of acute, short-term toxicity studies, indicate the safety of Super CitriMax®.
To assess its long-term safety, a variety of standard tests were conducted in Sprague-Dawley rats.
The animals were fed Super CitriMax® at varying concentrations of their food intake (0.2, 2.0 and 5.0%) over 1, 2 and 3 month periods.
Compared to control animals, both male and female rats supplemented with Super CitriMax® experienced a greater reduction in body weight over the 3 month period. No histopathological (microscopic) changes were observed in vital organs.
Neither fragmentation of DNA nor lipid peroxidation in liver and testis differed between Super CitriMax®-fed animals and controls, showing that Super CitriMax®Max® does not damage genetic material or cellular lipids in these tissues.
Taken together, these and previously reported results suggest that Super CitriMax® is a safe and effective dietary supplement for weight control.
This white paper study, presented at a 2004 Society of Toxicology annual meeting, documented that a key Diab-X® ingredient “did not cause any changes in major organs, blood or clinical chemistry or histopathology…support (ing) the safe use… as a dietary supplement for weight management.”