Clinical Trial: Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100"

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: "Phase II, Reduction of Dietary Mycotoxin Exposure in Persons in Bexar County, Texas by Ingestion of ACCS100 Capsules Compared to Placebo."

Brief Summary:

The primary purpose of the study is to evaluate the effectiveness of a naturally occurring clay substance (ACCS100) in reducing harmful effects of aflatoxin exposure (a carcinogen) and fumonisin (a cancer promoter). This clay substance contains of a variety of minerals including calcium, sodium, potassium, and magnesium. UPSN and similar aluminosilicate minerals have been regularly used as dietary supplements by humans and animals, and the safety of this naturally occurring clay substance has been tested in clinical trials. The FDA treats such minerals or nutritional supplements as a drug when tested for potential of lessening the likelihood of disease (i.e., potential for mitigating disease).

This study involves the use of an investigational drug called Hydrated Sodium Calcium Aluminosilicate (ACCS100). "Investigational" means that the "drug" has not yet been approved by the U.S. Food & Drug Administration (FDA) for reducing harmful effects mycotoxin exposure in humans.


Detailed Summary:

This planned clinical trial is a comparative study to determine the safety and effectiveness of ACCS100 capsules, the investigational product, vs. placebo in participants for the reduction of dietary mycotoxin exposure. One measure of effectiveness will be the analysis of the Bexar County participant's AFB1/FB1 metabolite levels in the blood and urine samples. Additionally, this clinical trial will determine the adherence to the dosing schedule of the participants; determine the prevalence of mycotoxin exposure in the screened population of residence of Bexar County, Texas; and compare side-effects and adverse events between ACCS100 and placebo in the participant population. These data will reveal the value of mineral enterosorbent strategies for the improvement of public health and for the well-being of humans at risk for dietary mycotoxin exposure and its consequences.

The proposed indication for ACCS100 is "for the reduction of dietary mycotoxin exposure in humans."

ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate (HSCAS), a substance generally recognized as safe (GRAS) by the FDA and has previously been shown to have no significant adverse effects when given as much as 4 grams per day to healthy study participants or immuno-compromised cancer patients.

Rationale

Our preliminary studies suggest that ACCS100 contains very low levels of trace metals and dioxins than are commonly found in smectite clays, and batch-to-batch QA/QC results for this material are more consistent. We anticipate that ACCS100 can be used as a primary intervention to bind both AFB1 and FB1 to decrease the external dose of toxins from the diet and in turn reduce the incidence of hepatic cancer and disease in vulnerable communitie
Sponsor: Texas Enterosorbents Incorporated

Current Primary Outcome: AFB1-lysine Adduct (pg/mg) Overtime [ Time Frame: 3 months on intervention (weeks 0-12); 1 month off intervention (week 16) ]

After randomization, participants provided serum samples at baseline, weeks 4, 12, and 16. Week 16 represents one month off treatment.


Original Primary Outcome: Reduction of dietary mycotoxin (Aflatoxin-AFB1 and Fumonisin-FB1) exposure in participants in Bexar County, Texas [ Time Frame: Two year study ]

We hypothesize that ingesting ACCS100 prior to each meal (total of 1.5 or 3 g/day) will reduce the participant's exposure to AFB1 and FB1 as indicated by blood and urine levels of AFB1/FB1 metabolites. The ultimate purpose of this project will be to reveal the value of mineral enterosorbent strategies to reduce exposure to dietary mycotoxin risk factors for disease.


Current Secondary Outcome:

Original Secondary Outcome: Compare side-effects and adverse events between ACCS100 and placebo in the participant population [ Time Frame: 2 Year study ]

The raw material from which ACCS100 is produced is generally recognized as safe (GRAS) by the FDA, is an approved food and feed additive, and is considered safe at up to 40 grams of a 2 kg/day diet. The maximum dose of ACCS100 for this study is 3.0 grams per day or less than one-tenth of the maximum level in food permitted by the FDA.


Information By: Texas Enterosorbents Incorporated

Dates:
Date Received: August 29, 2012
Date Started: September 2012
Date Completion:
Last Updated: March 20, 2016
Last Verified: March 2016