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

September 11, 2020 updated by: Children's Hospital Medical Center, Cincinnati
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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Anniston, Alabama, United States, 36201
        • West Anniston Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elevated blood level of PCBs

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: olestra
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.
non-absorbable dietary fat
Other Names:
  • Olean
  • non absorbable fat
  • fat substitute
PLACEBO_COMPARATOR: Vegetable oil
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.
non-absorbable dietary fat
Other Names:
  • Olean
  • non absorbable fat
  • fat substitute

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year
Rate of Change of Lipid Adjusted PCB Levels
Time Frame: One year
This is a measure of the change in body burden of PCBs
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ronald J Jandacek, Ph.D., University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 15, 2010

First Posted (ESTIMATE)

December 16, 2010

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10100801 1R21ES019206-01
  • 1R21ES019206-01 (NIH)
  • 8 UL1 TR00007 (OTHER_GRANT: NCRR and NCATS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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