Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100"
Condition: Dietary Carcinogenesis
MeSH terms: Carcinogenesis
Intervention: ACCS100; Placebo
Intervention description: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article.; Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article.
Intervention MeSH terms: Calcium Carbonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mycotoxins; Aflatoxin; Fumonisin; Aflatoxicosis; Dietary; Cancer

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.
    

Eligibility criteria:

        Inclusion Criteria:

        3.1 Participant Inclusion Criteria 3.1.1 Detectable blood AFB1-albumin adduct levels (limit
        of detection=0.01 pmol/mg albumin) 3.1.2 18 -85 years 3.1.3 Ability to take oral capsules
        3.1.4 Negative urine pregnancy test for women of childbearing age 3.1.5 Must have the
        ability to understand and the willingness to provide a written informed consent to
        participate in the study

        Exclusion Criteria:

        3.2 Participant Exclusion Criteria 3.2.1 History of known allergy to silicates 3.2.2
        Pregnancy or lactation 3.2.3 History of significant neurological or psychiatric disorders
        that would impede giving consent, treatment, or follow up 3.2.4 Any serious systemic
        disorders incompatible with the study 3.2.5 History of chronic disease (ie heart disease,
        renal disease). A participant may have a diagnosis of and be managed for diabetes) Any
        recent diagnosis of cancer.

        3.2.6 Participation in any other clinical study where the participant is actively taking an
        investigational medication within the last 30 days

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