Clinical trial NCT01261338: Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama
Official title: Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Toxic Effect of Other Corrosive Organic Compounds
Keywords: PCBs
Olestra
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
name: University of Cincinnati
First posted: 2010-12-16
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Elevated blood level of PCBs

Exclusion Criteria:

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

Primary outcomes:
measure: Percent Change From Baseline for Total PCB Levels
timeFrame: one year
measure: Rate of Change of Lipid Adjusted PCB Levels
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
facility: West Anniston Foundation
state: Alabama
Study officials:
affiliation: University of Cincinnati
name: Ronald J Jandacek, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jandacek RJ, Heubi JE, Buckley DD, Khoury JC, Turner WE, Sjodin A, Olson JR, Shelton C, Helms K, Bailey TD, Carter S, Tso P, Pavuk M. Reduction of the body burden of PCBs and DDE by dietary intervention in a randomized trial. J Nutr Biochem. 2014 Apr;25(4):483-8. doi: 10.1016/j.jnutbio.2014.01.002. Epub 2014 Jan 29.