Weight Loss Aid in an Exposed Population

Emory University

Status and phase: Completed; Phase 4

Conditions: Polybrominated Biphenyl Poisoning

Treatments: Dietary Supplement: Multivitamin; Drug: Placebo capsule; Drug: Orlistat

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03582722

IRB00099231

R01ES025775 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• BMI<25
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Orlistat Weight Loss Aid

Experimental group

Description:

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.

Treatment:

Drug: Orlistat

Dietary Supplement: Multivitamin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo capsule

Dietary Supplement: Multivitamin