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Weight Loss Aid in an Exposed Population

NCT03582722 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-04-25

Study results available
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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).

Conditions

  • Polybrominated Biphenyl Poisoning

Interventions

DRUG

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.

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.

DIETARY_SUPPLEMENT

Multivitamin

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

Sponsors & Collaborators

  • Healthway Compounding Pharmacy

    collaborator INDUSTRY

  • Michigan Public Health Departments

    collaborator OTHER_GOV

  • National Institute of Environmental Health Sciences (NIEHS)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Michele Marcus, PhD, MPH · School of Public Health, Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-14
Primary Completion
2022-06-30
Completion
2022-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03582722 on ClinicalTrials.gov