Completed

NCT Number: NCT01261338

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

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.

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Key information

Conditions

Toxic Effect of Other Corrosive Organic Compounds

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

West Anniston Foundation

Anniston, Alabama, 36201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Elevated blood level of PCBs

Exclusion criteria

Pregnancy
Breast-feeding
Weight-loss medication
Gastrointestinal disease

Treatment and study plan

olestra

Drug

non-absorbable dietary fat

Other names: Olean, non absorbable fat, fat substitute

Primary outcomes

Percent Change From Baseline for Total PCB Levels

Time frame: one year

The outcome is the percent change in body burden of total PCB's measured over one year. Initially the percent of baseline is calculated as (value at one year / value at baseline) *100, then this is examined modeling over time as compared to the 100% at baseline.
Rate of Change of Lipid Adjusted PCB Levels

Time frame: One year

This is a measure of the change in body burden of PCBs

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

National Institute of Environmental Health Sciences (NIEHS)
University of Cincinnati

Registry information

Acronym: PCBs

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Dec 16, 2010
Registry last updated: Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.