Toxic Effect of Other Corrosive Organic CompoundsEarly Phase 1PCBsNCT01261338
Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama
A Early Phase 1 study testing olestra in people with Toxic Effect of Other Corrosive Organic Compounds, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Toxic Effect of Other Corrosive Organic Compounds
- What is being tested?
- olestra
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Oct 2012
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elevated blood level of PCBs
Who cannot join
- Pregnancy
- Breast-feeding
- Weight-loss medication
- Gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- olestra
- Keywords
- PCBs, Olestra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olestraDrug
Also called Olean, non absorbable fat, fat substitute
non-absorbable dietary fat
| Study group | Role | What they receive |
|---|---|---|
| olestra | Experimental | 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. Receives: Drug: olestra |
| Vegetable oil | Placebo comparator | 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. Receives: Drug: olestra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline for Total PCB Levels
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.
Measured: one year
Rate of Change of Lipid Adjusted PCB Levels
This is a measure of the change in body burden of PCBs
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Toxic Effect of Other Corrosive Organic CompoundsStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Ronald J Jandacek, Ph.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261338
- Sponsor's protocol ID
- 10100801 1R21ES019206-01
- Other IDs
- 1R21ES019206-01, 8 UL1 TR00007
- Acronym
- PCBs
- Status last verified
- Dec 2016
- First submitted
- 14 Dec 2010
- Last updated
- 14 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24629911
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Reduce Body Burdens of PCBs in Residents of Anniston, Alabama
- ClinicalTrials.gov ID
- NCT01261338
- Acronym / sponsor ID
- PCBs / 10100801 1R21ES019206-01
- Keywords
- PCBs, Olestra
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), University of Cincinnati
- Study start
- Dec 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Posted 14 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olestra | Experimental | Drug: olestraNon-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. |
| Vegetable oil | Placebo comparator | Drug: olestraAbsorbable 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elevated blood level of PCBs
Key exclusion criteria (4 listed)
- Pregnancy
- Breast-feeding
- Weight-loss medication
- Gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olestraAlso: Olean, non absorbable fat, fat substitutenon-absorbable dietary fat | Drug | Vegetable oil, olestra |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24629911Jandacek 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald J Jandacek, Ph.D. principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing olestra in people with Toxic Effect of Other Corrosive Organic Compounds, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline for Total PCB Levels (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01261338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.