跳至主要内容
临床试验/NCT01261338
NCT01261338已完成早期 1 期

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

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
28
试验地点
1
主要终点
Percent Change From Baseline for Total PCB Levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elevated blood level of PCBs

排除标准

  • Pregnancy
  • Breast-feeding
  • Weight-loss medication
  • Gastrointestinal disease

研究组 & 干预措施

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.

干预措施: olestra (Drug)

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.

干预措施: olestra (Drug)

结局指标

主要结局

Percent Change From Baseline for Total PCB Levels

时间窗: 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

时间窗: One year

This is a measure of the change in body burden of PCBs

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验