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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by University of Cincinnati.
Recruitment status was:  Active, not recruiting
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
  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

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Lipid Regulating Agents

ClinicalTrials.gov processed this record on December 09, 2016