Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama
Condition: Toxic Effect of Other Corrosive Organic Compounds
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Because of industrial pollution, a large number of people in Anniston, Alabama, have elevated
      body burdens of the class of compounds known as polychlorinated biphenyls (PCBs). There is
      evidence that these compounds are associated with risks to health including diabetes. There
      is also evidence that the consumption of a non-absorbable dietary fat can reduce the level of
      compounds like PCBs. This clinical trial will test the hypothesis that a non-absorbable
      dietary fat can reduce the levels of PCBs in subjects in Anniston.
    

Detailed description: 
      A clinical trial will be conducted which will test the use of a safe and minimally invasive
      dietary intervention to enhance the removal of toxic polychlorinated biphenyls (PCBs) from
      individuals with elevated levels of these compounds. To conduct this study, participants will
      be recruited and enrolled in Anniston, Alabama, a community in which a significant portion of
      the local population has been exposed to PCBs as a result of contaminated commercial waste.
      Many of the residents of Anniston currently have markedly elevated blood and adipose tissue
      PCB levels. In addition, these individuals have a several-fold increased prevalence of type-2
      diabetes and are potentially at greater risk of other health disorders. .

      A method was developed for adding a small amount of non-absorbable fat to the diet for use as
      a therapeutic tool which hastens the elimination of persistent lipophilic compounds, such as
      PCBs, in a safe manner. The rationale is based on the fact that once PCBs and other
      organochlorine pollutants enter the body, they circulate among several organs including the
      small intestine. Under normal circumstances, these compounds are reabsorbed from the
      intestine and returned to the blood, and are thus prevented from being excreted in the feces.
      The addition of a small amount of non-absorbable lipid in the diet provides a matrix for
      physically retaining the pollutants within the intestinal lumen, which then allows the
      pollutants to be excreted along with the lipid. Although the excretion on any given day is
      relatively small, the cumulative excretion over the course of a year becomes clinically
      significant. The Anniston population provides an ideal population to assess this intervention
      in a meaningful way, and we have allied with a local community group to assist in the
      recruitment of subjects and to carry out the relatively simple dietary manipulations required
      for this study.

      A double-blind, placebo controlled study of a non-absorbable fat in subjects known to have
      elevated levels of PCBs will be conducted. The rate of change of the blood levels of PCBs in
      these subjects will be measured.
    

Intervention name(s): olestra
Intervention type(s): Drug
Intervention description(s): non-absorbable dietary fat
Other intervention name(s): Olean; non absorbable fat; fat substitute
Intervention MeSH terms: Sucrose polyester
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PCBs; Olestra