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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Ronald Jandacek, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01261338
First received: December 14, 2010
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

Because of industrial pollution, a large number of people in Annison, 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.


Condition Intervention
Body Burden of Potentially Toxic Lipophilic Compounds
 Drug: olestra

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama

Resource links provided by NLM:

MedlinePlus related topics: Dietary Fats
U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Rate of change of blood levels of PCBs. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: December 2010
Estimated Study Completion Date: October 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: olestra
Non-absorbable fat
 Drug: olestra
non-absorbable dietary fat

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elevated blood level of PCBs

Exclusion Criteria:

  • Pregnancy
  • Breast-feeding
  • Weight-loss medication
  • Gastrointestinal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261338

Locations
United States, Alabama
West Anniston Foundation
Anniston, Alabama, United States, 36201
Sponsors and Collaborators
Ronald Jandacek
National Institute of Environmental Health Sciences (NIEHS)
Investigators
Principal Investigator: Ronald J Jandacek, Ph.D. University of Cincinnati
  More Information

No publications provided

Responsible Party: Ronald Jandacek, Adjunct Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01261338     History of Changes
Other Study ID Numbers: 10100801 1R21ES019206-01, 1R21ES019206-01
Study First Received: December 14, 2010
Last Updated: October 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
PCBs
Olestra

Additional relevant MeSH terms:
Sucrose polyester
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013