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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21ES019206-01 | U.S. NIH Grant/Contract | View source | |
| 8 UL1 TR00007 | Other Grant/Funding Number | NCRR and NCATS |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
| University of Cincinnati | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olestra | Drug | non-absorbable dietary fat |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one year |
| Rate of Change of Lipid Adjusted PCB Levels | This is a measure of the change in body burden of PCBs | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald J Jandacek, Ph.D. | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Anniston Foundation | Anniston | Alabama | 36201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24629911 | Result | 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. |
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Participants were randomized into groups of 14 each, to receive either olestra and vegetable oil.
Twenty-eight participants were recruited prior to April 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olestra | Non-absorbable fat olestra : non-absorbable dietary fat |
| FG001 | Vegetable Oil | absorbable fat |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Olestra | Non-absorbable fat olestra : non-absorbable dietary fat |
| BG001 | Vegetable Oil | absorbable fat |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol, based on elevated PCB levels | Posted | Mean | Standard Error | % of baseline total PCBs | one year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olestra | Non-absorbable fat olestra : non-absorbable dietary fat |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized for heart catheter | Cardiac disorders | Non-systematic Assessment | Participant had a previous history of heart disease. There as no relationship to the study treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald J. Jandacek, PhD, Principal Investigator | University of Cincinnati | 513-558-5492 | ronald.jandacek@uc.edu |
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| ID | Term |
|---|---|
| C013692 | sucrose polyester |
| D019358 | Fat Substitutes |
| ID | Term |
|---|---|
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Rate of Change of Lipid Adjusted PCB Levels | This is a measure of the change in body burden of PCBs | All participants who completed the trial were analyzed. | Posted | Mean | Standard Error | ng/g lipid/year | One year |
|
|
|
| 2 |
| 14 |
| 9 |
| 14 |
| EG001 | Vegetable Oil | absorbable fat | 2 | 14 | 9 | 14 |
|
| Bleeding Ulcers | Gastrointestinal disorders | Non-systematic Assessment | Admitted to hospital |
|
| Chest pain and palpitations | Cardiac disorders | Non-systematic Assessment | Admitted to hospital |
|
| Heart stent replacement | Cardiac disorders | Non-systematic Assessment |
|
| Cold | General disorders | Non-systematic Assessment |
|
| Rash on body | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Irregular heartbeat | Cardiac disorders | Non-systematic Assessment |
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| Pain in right hip | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Rash on left and right anticubital area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Infection in lining of rib cage | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Indigestion | Gastrointestinal disorders | Non-systematic Assessment |
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| Gout | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Sinus infection | Infections and infestations | Non-systematic Assessment |
|
| Yeast Infection | Infections and infestations | Non-systematic Assessment |
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| HGA1C elevated 6.4% | Endocrine disorders | Non-systematic Assessment |
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| Cough | General disorders | Non-systematic Assessment |
|
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| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |