Short-term safety evaluation of processed calcium montmorillonite clay (NovaSil) in humans

Abstract

NovaSil clay (NS) provides significant protection from the adverse effects of aflatoxins (AFs) in multiple animal species by decreasing bioavailability from the gastrointestinal tract. It is postulated that NS clay can be safely added to human diets to diminish exposure and health risks from AF contaminated food. To determine the safety and tolerance of NS in humans and establish dosimetry protocols for long-term efficacy studies, a randomized and double-blinded phase I clinical trial was conducted. Volunteers (20-45 yr in age), were clinically screened for confirmation of their health status. Fifty subjects (23 males and 27 females) were randomly divided into two groups: The low-dose group received nine capsules containing 1.5 g/day, and the high-dose group received nine capsules containing 3.0 g/day for a period of 2?wk. NS capsules were manufactured in the same color and size and were distributed to each participant three times a day at designated sites where follow-up was taken to record any side effects and complaints. Blood and urine samples were collected before and after the study for laboratory analysis. All participants completed the trial and compliance was 99.1%. Mild GI effects were reported in some participants. Symptoms included abdominal pain (6%, 3/50), bloating (4%, 2/50), constipation (2%, 1/50), diarrhea (2%, 1/50), and flatulence (8%, 4/50). No statistical significance was found between the two groups for these adverse effects (p > 0.25). No significant differences were shown in hematology, liver and kidney function, electrolytes, vitamins A and E, and minerals in either group. These results demonstrate the relative safety of NS clay in human subjects and will serve as a basis for long-term human trials in populations at high risk for aflatoxicosis.

Protective Interventions to Prevent Aflatoxin-Induced Carcinogenesis in Developing Countries

“…Compliance was outstanding, and by the end of the study there were no statistically significant differences between the two groups for adverse health complaints nor were there dif-NS: NovaSil ferences in any of the clinical chemistries or any other health parameter measured. Thus these findings provide an initial step for the translation of NS from use in the protection of animals from the adverse health effects of aflatoxins to a potential application for use in human populations at high risk for aflatoxicosis (76).…”

Short-Term Safety and Efficacy of Calcium Montmorillonite Clay (UPSN) in Children

“…36,[46][47][48] Results of NS clay phase I and II clinical trials suggest that ingestion of up to 3 g/ day in adults is safe for a 3-month period. [49][50][51] Based on detailed studies conducted in animals and humans, it was determined that ingestion of UPSN at levels efficacious for reducing AFB 1 biomarkers would be reasonably safe in children.…”

Efficacy of Organo-Modified Nano Montmorillonite to Protect against the Cumulative Health Risk of Aflatoxin B<sub>1</sub> and Ochratoxin A in Rats

“…In previous works, the dietary inclusion of clay minerals at a level of 0.5% (w/w) did not show any toxic effect regarding biochemical, haematological and immunological parameters in laboratory animals [43]. Furthermore, the addition of calcium montmorillonite did not show any toxic effects in the equilibrium of vitamins and gain minerals in the human blood [44].…”