Weight Loss Aid in an Exposed Population

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-14

Study Completion Date

2022-06-30

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Polybrominated Biphenyl Poisoning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Orlistat

Intervention Type DRUG

Participants will be instructed to take one 60mg capsule of orlistat with each meal containing fat, up to three capsules daily, for six months.

Multivitamin

Intervention Type DIETARY_SUPPLEMENT

A multivitamin will be provided to be taken once daily, at bedtime.

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.

Group Type PLACEBO_COMPARATOR

Placebo capsule

Intervention Type DRUG

Participants will be instructed to take one placebo capsule to match 60mg of orlistat with each meal containing fat, up to three capsules daily, for six months.

Multivitamin

Intervention Type DIETARY_SUPPLEMENT

A multivitamin will be provided to be taken once daily, at bedtime.

Interventions

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Orlistat

Participants will be instructed to take one 60mg capsule of orlistat with each meal containing fat, up to three capsules daily, for six months.

Intervention Type DRUG

Placebo capsule

Participants will be instructed to take one placebo capsule to match 60mg of orlistat with each meal containing fat, up to three capsules daily, for six months.

Intervention Type DRUG

Multivitamin

A multivitamin will be provided to be taken once daily, at bedtime.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Alli

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No