Weight Loss Aid in an Exposed Population

NCT03582722 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB00099231R01ES025775
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Polybrominated Biphenyl Exposure; Gastrointestinal lipase inhibitor

Outcome Measures

Primary Outcomes (2)

• Weight

  Participant weight, in kilograms, was measured in light clothing without shoes on a regularly calibrated digital scale.

  Enrollment, Month 3, Month 6

• Body Mass Index (BMI)

  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.

  Enrollment, Month 3, Month 6

Secondary Outcomes (7)

• Serum Concentration of Polybrominated Biphenyl (PBB) 153

  Enrollment, Month 3, Month 6

• Serum Concentration of Polybrominated Diphenyl Ether (PBDE) 47

  Enrollment, Month 3, Month 6

• Serum Concentration of Polychlorinated Biphenyl (PCB) 118

  Enrollment, Month 3, Month 6

• Serum Concentration of PCB 138

  Enrollment, Month 3, Month 6

• Serum Concentration of PCB 153

  Enrollment, Month 3, Month 6

Study Arms (2)

Orlistat Weight Loss Aid

EXPERIMENTAL

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.

Drug: Orlistat; Dietary Supplement: Multivitamin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo capsule; Dietary Supplement: Multivitamin

Interventions

Orlistat 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.

Also known as: Alli

Orlistat Weight Loss Aid

Placebo capsule 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.

Placebo

Multivitamin DIETARY_SUPPLEMENT

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

Orlistat Weight Loss Aid; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Healthway Compounding Pharmacy: collaborator
• Michigan Public Health Departments: collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Michele Marcus

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Orlistat; Geritol

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals

Results Point of Contact

• Title: Michele Marcus, PhD, MPH
• Organization: Emory University

mmarcus@emory.edu

404-727-8010

Study Officials

• Michele Marcus, PhD, MPH

  School of Public Health, Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 11, 2018
• Study Start: September 14, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 25, 2024
• Results First Posted: April 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)