Phase 4
N=100
Weight Loss Aid in an Exposed Population
Polybrominated Biphenyl Poisoning
Bottom Line
View on ClinicalTrials.gov: NCT03582722 ↗Enrolled (actual)
100
Serious AEs
3.0%
Results posted
Apr 2024
Primary outcome: Primary: Weight — 91.3; 92.3; 88.6; 87.4 kilograms (kg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Orlistat (Drug); Placebo capsule (Drug); Multivitamin (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight |
91.3; 92.3; 88.6; 87.4; 90.4; 93.2 | — |
| PRIMARY Body Mass Index (BMI) |
32.3; 31.7; 31.5; 29.9; 31.6; 32.3 | — |
| SECONDARY Serum Concentration of Polybrominated Biphenyl (PBB) 153 |
0.454; 0.276; 0.355; 0.395; 0.481; 0.290 | — |
| SECONDARY Serum Concentration of Polybrominated Diphenyl Ether (PBDE) 47 |
0.032; 0.028; 0.034; 0.025; 0.029; 0.025 | — |
| SECONDARY Serum Concentration of Polychlorinated Biphenyl (PCB) 118 |
0.035; 0.026; 0.031; 0.024; 0.028; 0.025 | — |
| SECONDARY Serum Concentration of PCB 138 |
0.081; 0.064; 0.070; 0.066; 0.078; 0.064 | — |
| SECONDARY Serum Concentration of PCB 153 |
0.122; 0.096; 0.100; 0.105; 0.114; 0.105 | — |
| SECONDARY Serum Concentration of PCB 180 |
0.116; 0.108; 0.101; 0.114; 0.112; 0.121 | — |
| SECONDARY Serum Concentration of Dichlorodiphenyldichloroethylene (DDE) |
0.535; 0.490; 0.539; 0.490; 0.573; 0.498 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03582722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.