Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama

Cincinnati Children's Hospital Medical Center

Status and phase: Completed; Early Phase 1

Conditions: Toxic Effect of Other Corrosive Organic Compounds

Treatments: Drug: olestra

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01261338

8 UL1 TR00007 (Other Grant/Funding Number)

1R21ES019206-01 (U.S. NIH Grant/Contract)

10100801 1R21ES019206-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Elevated blood level of PCBs

Exclusion criteria

• Pregnancy
• Breast-feeding
• Weight-loss medication
• Gastrointestinal disease

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

28 participants in 2 patient groups, including a placebo group

olestra

Experimental group

Description:

Non-absorbable fat administered in the form of 24 potato crisps per day (12 each with mid-day and evening meal) providing approximately 15g/day of olestra.

Treatment:

Drug: olestra

Vegetable oil

Placebo Comparator group

Description:

Absorbable fat administered in the form of 12 potato crisps per day (6 each with mid-day and evening meal) in order to match the caloric intake provided by the crisps with Olestra.

Treatment:

Drug: olestra