Toxic Effect of Other Corrosive Organic Compounds
Conditions
Keywords
PCBs, Olestra
Brief 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. 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.
Interventions
DRUGolestra
non-absorbable dietary fat
Sponsors
National Institute of Environmental Health Sciences (NIEHS)
University of Cincinnati
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Elevated blood level of PCBs
Exclusion criteria
* Pregnancy * Breast-feeding * Weight-loss medication * Gastrointestinal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline for Total PCB Levels | 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 | One year | This is a measure of the change in body burden of PCBs |
Countries
United States
Participant flow
Recruitment details
Twenty-eight participants were recruited prior to April 2011.
Pre-assignment details
Participants were randomized into groups of 14 each, to receive either olestra and vegetable oil.
Participants by arm
| Arm | Count |
|---|---|
| Olestra Non-absorbable fat
olestra : non-absorbable dietary fat | 14 |
| Vegetable Oil absorbable fat | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Vegetable Oil | Olestra | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 9 Participants | 20 Participants |
| Age, Continuous | 61.0 years STANDARD_DEVIATION 5.7 | 59.9 years STANDARD_DEVIATION 9.6 | 60.6 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment United States | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 14 | 9 / 14 |
| serious Total, serious adverse events | 2 / 14 | 2 / 14 |
Outcome results
Primary
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.
Time frame: one year
Population: Per protocol, based on elevated PCB levels
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olestra | Percent Change From Baseline for Total PCB Levels | 92 % of baseline total PCBs | Standard Error 3.4 |
| Vegetable Oil | Percent Change From Baseline for Total PCB Levels | 96 % of baseline total PCBs | Standard Error 4.3 |
Primary
Rate of Change of Lipid Adjusted PCB Levels
This is a measure of the change in body burden of PCBs
Time frame: One year
Population: All participants who completed the trial were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olestra | Rate of Change of Lipid Adjusted PCB Levels | -0.0829 ng/g lipid/year | Standard Error 0.0357 |
| Vegetable Oil | Rate of Change of Lipid Adjusted PCB Levels | -0.0413 ng/g lipid/year | Standard Error 0.0408 |