Use of a Weight Loss Aid in a Population Exposed to Polybrominated Biphenyls (PBB)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
This study will explore whether the use of orlistat results in weight loss that is accompanied by a reduction in the body burdens of polybrominated biphenyls (PBB) and other Persistent Organic Pollutants (POPs).
详细描述
Millions of people living in Michigan were exposed to brominated flame retardants (polybrominated biphenyls or PBB) as a result of the largest agricultural disaster in US history. Over the past six years, Emory researchers have tested nearly 900 Michigan residents and determined that 60% still had PBB in their bodies from that disaster. PBB is stored in body fat and the researchers at Emory have been asked by community members if weight loss might reduce their body burdens of PBB and other lipophilic chemicals. In an effort to understand how PBB and other persistent organic pollutants (POPs) are eliminated, the researchers are conducting a randomized trial of orlistat versus placebo.
Orlistat is an over-the-counter product approved by the FDA for weight loss and works by increasing excretion of fat into the stool. Since PBB is stored in body fat, the researchers hypothesize that orlistat may reduce the body burden of PBB and other POPs. This study is a randomized, placebo-controlled trial of orlistat (at the dose available over-the-counter) plus diet and exercise for 6 months in a population with elevated PBB levels. Participants will be healthy overweight adults and orlistat will be taken as directed for the approved indication (weight loss).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •current or recent (within the last five years) serum PBB level of ≥1ppb, or are a member of a sub-group likely to have high serum PBB (former chemical worker, family member of former chemical worker, lived on a farm with animals that were quarantined because of PBB exposure)
- •at least 18 years old
- •currently reside in Michigan
- •able to participate in examinations and laboratory tests (a lipid panel, liver function test, thyroid function and and creatinine levels) done at at a local health department or other medical health facility and to be able to engage in moderate physical activity (e.g. walking)
- •participants with undiagnosed abdominal pain or diarrhea, Crohn's disease, Ulcerative Colitis, Celiac Disease, treated diabetes or treated thyroid disorder, will only be eligible following consultation with their primary care provider
- •any participant using levothyroxine will be instructed to take their dosage 4 hours before or after Orlistat in order to maintain eligibility
排除标准
- •abnormal liver function
- •abnormal creatinine levels
- •abnormal thyroid levels (TSH)
- •have type 1 diabetes
- •have had an organ transplant
- •are pregnant or lactating
- •current use of weight-loss medications, oral steroids, Coumadin, warfarin or Cyclosporine
- •have a diagnosed problem absorbing food, or have an eating disorder
- •a history of bariatric surgery, pancreatitis, kidney stones, gall bladder disorder or a serious chronic disease (e.g. uncontrolled diabetes, congestive heart failure, chronic kidney disease)
- •allergies to any ingredients of the Orlistat over-the-counter (OTC) capsules
- •participants will become ineligible at any point during the study if they begin a medical regimen involving any of the above medications
研究组 & 干预措施
Orlistat Weight Loss Aid
Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin will also be recommended and monitored.
干预措施: Orlistat (Drug)
Orlistat Weight Loss Aid
Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin will also be recommended and monitored.
干预措施: Multivitamin (Dietary Supplement)
Placebo
Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin will also be recommended and monitored.
干预措施: Placebo capsule (Drug)
Placebo
Participants randomized to take a placebo to match orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin will also be recommended and monitored.
干预措施: Multivitamin (Dietary Supplement)
结局指标
主要结局
Weight
时间窗: Enrollment, Month 3, Month 6
Participant weight, in kilograms, was measured in light clothing without shoes on a regularly calibrated digital scale.
Body Mass Index (BMI)
时间窗: Enrollment, Month 3, Month 6
Body Mass Index is a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters and used as an indicator of obesity and underweight. Participants had their weight measured in light clothing without shoes on a regularly calibrated digital scale. Height is measured using a well-mounted stadiometer.
次要结局
- Serum Concentration of Polybrominated Diphenyl Ether (PBDE) 47(Enrollment, Month 3, Month 6)
- Serum Concentration of PCB 138(Enrollment, Month 3, Month 6)
- Serum Concentration of Polychlorinated Biphenyl (PCB) 118(Enrollment, Month 3, Month 6)
- Serum Concentration of PCB 153(Enrollment, Month 3, Month 6)
- Serum Concentration of Polybrominated Biphenyl (PBB) 153(Enrollment, Month 3, Month 6)
- Serum Concentration of Dichlorodiphenyldichloroethylene (DDE)(Enrollment, Month 3, Month 6)
- Serum Concentration of PCB 180(Enrollment, Month 3, Month 6)