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Weight Loss Aid in an Exposed Population

Primary Purpose

Polybrominated Biphenyl Poisoning

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Orlistat

Placebo capsule

Multivitamin

About this trial

This is an interventional treatment trial for Polybrominated Biphenyl Poisoning focused on measuring Polybrominated Biphenyl Exposure, Gastrointestinal lipase inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Michele Marcus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Orlistat Weight Loss Aid

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in weight

Participants will have their weight measured in light clothing without shoes on a regularly calibrated digital scale.

Change in Body Mass Index

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 will have their weight measured in light clothing without shoes on a regularly calibrated digital scale. Height will be measured using a well-mounted stadiometer.

Secondary Outcome Measures

Change in dietary intake using Automated Self-administered 24-hour Recall score

Participants will be asked to recall their food and beverage intake during the previous 24-hour period using the most recent version of the Automated Self-Administered 24-hour (ASA24) Recall - an interactive web-based system sponsored by NCI - that prompts participants for food description details and automatically codes and calculates nutrient intakes. Details are described here: https://epi.grants.cancer.gov/hei/developing.html Using data collected from ASA24 recalls, two outcomes will be assessed: diet quality and percent of calories from fat. Diet quality will be assessed with the Healthy Eating Index (HEI-2015). This Index contains 13 components that sum to a maximum of 100 points (minimum 0 points; higher scores are better). Percent of calories from fat will be calculated by dividing the total calories from fat by the total calories consumed.These are continuous variables. We will determine if the percent calories from fat is reduced during the course of the trial.

Change in physical activity

Change in physical activity will be assessed using the Women's Health Initiative Physical Activity Questionnaire (WHI-PAQ) which assesses physical activity across several domains (leisure, domestic and yard, work and transportation-related activities) and when scored can provide metrics of total minutes/week spent in various categories of activity and can be transformed to metabolic equivalent (MET) values for overall activity. A physical activity summary variable will be created by combining frequency, duration and MET-estimated intensity: (Frequency of activity per week × Minutes per session × MET for that activity) / (60 min/hour)

Change in serum concentration of polybrominated biphenyl (PBB) 153

PBB is an organic bromine compound that is environmentally toxic and is classified as a persistent organic pollutant. PBB 153 concentration in serum is measured in parts per billion (ppb).

Change in serum concentration of polybrominated diphenyl ether (PBDE) 47

PBDE is an organic bromine compound that is environmentally toxic and is classified as a persistent organic pollutant. PBDE 47 concentration in serum is measured in ppb.

Change in serum concentration of polychlorinated biphenyl (PCB) 118

PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. PCB 118 concentration in serum is measured in ppb.

Change in serum concentration of PCB 138

PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. PCB 138 concentration in serum is measured in ppb.

Change in serum concentration of PCB 153

PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. PCB 153 concentration in serum is measured in ppb.

Change in serum concentration of PCB 180

PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. PCB 180 concentration in serum is measured in ppb.

Change in serum concentration of dichlorodiphenyltrichloroethane (DDT)

DDT is a pesticide that was banned in 1972. High levels of DDT can impact the nervous system, including causing tremors or seizures. DDT concentration in serum is measured in ppb.

Change in serum concentration of dichlorodiphenyldichloroethylene (DDE)

DDE is a chemical produced by the breakdown of DDT. High levels of DDE can impact lactation and increase the risk of preterm birth. DDE concentration in serum is measured in ppb.

Full Information

NCT ID

NCT03582722

First Posted

June 28, 2018

Last Updated

September 6, 2023

Sponsor

Emory University

Collaborators

Healthway Compounding Pharmacy in central Michigan, Michigan Public Health Departments, National Institute of Environmental Health Sciences (NIEHS)

1. Study Identification

Unique Protocol Identification Number

NCT03582722

Brief Title

Weight Loss Aid in an Exposed Population

Official Title

Use of a Weight Loss Aid in a Population Exposed to Polybrominated Biphenyls (PBB)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

September 14, 2018 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Healthway Compounding Pharmacy in central Michigan, Michigan Public Health Departments, National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polybrominated Biphenyl Poisoning

Keywords

Polybrominated Biphenyl Exposure, Gastrointestinal lipase inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Orlistat Weight Loss Aid

Arm Type

Experimental

Arm 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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Orlistat

Other Intervention Name(s)

Alli

Intervention Description

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

Intervention Name(s)

Placebo capsule

Intervention Description

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

Dietary Supplement

Intervention Name(s)

Multivitamin

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in weight

Description

Participants will have their weight measured in light clothing without shoes on a regularly calibrated digital scale.

Time Frame