Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100" (RDMEACCS100)
Dietary Carcinogenesis
About this trial
This is an interventional prevention trial for Dietary Carcinogenesis focused on measuring Mycotoxins, Aflatoxin, Fumonisin, Aflatoxicosis, Dietary, Cancer
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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Sites / Locations
- University of Texas Health Science Center Cancer Therapy and Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
ACCS100 High Dose
ACCS100 Low Dose
Placebo
Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.
Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.
Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.