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| ID | Type | Description | Link |
|---|---|---|---|
| R01ES025775 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Healthway Compounding Pharmacy | INDUSTRY |
| Michigan Public Health Departments | OTHER_GOV |
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 nanograms per milliliter (ng/mL). | Enrollment, Month 3, Month 6 |
| Serum Concentration of Polybrominated Diphenyl Ether (PBDE) 47 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele Marcus, PhD, MPH | School of Public Health, Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michele Marcus | Atlanta | Georgia | 30322 | United States |
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100 individuals gave consent to participate in the study and were randomized to a study arm. One participant who was randomized to the Orlistat arm did not begin taking the study medication and did not complete the first study visit.
Participants were recruited from the Michigan polybrominated biphenyls (PBB) Research Registry. Participant enrollment began September 14, 2018 and all follow-up assessments were completed by June 30, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 were also recommended and monitored. Placebo capsule: Participants were 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: A multivitamin was provided to be taken once daily, at bedtime. |
| FG001 | 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 were also recommended and monitored. Orlistat: Participants were instructed to take one 60mg capsule of orlistat with each meal containing fat, up to three capsules daily, for six months. Multivitamin: A multivitamin was provided to be taken once daily, at bedtime. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Baseline Analysis Population includes participants who completed both the Enrollment visit and the Month 3 visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 were also recommended and monitored. |
| BG001 | Orlistat Weight Loss Aid |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight | Participant weight, in kilograms, was measured in light clothing without shoes on a regularly calibrated digital scale. | This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-five participants were not able to attend the Month 3 study visit in person; 23 due to the Coronavirus 2019 (COVID-19) pandemic and an additional 2 due to other reasons. All of participants who were unable to have the in-person Month 3 visit provided a self-measured weight. Mean weights measured per protocol and self-measured are reported separately. | Posted | Mean | Standard Deviation | kilograms (kg) | Enrollment, Month 3, Month 6 |
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Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 6 Month study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 were also recommended and monitored. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart attack | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele Marcus, PhD, MPH | Emory University | 404-727-8010 | mmarcus@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2018 | Mar 24, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2018 | Mar 3, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000077403 | Orlistat |
| C067316 | Geritol |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| 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. |
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| Multivitamin | Dietary Supplement | A multivitamin will be provided to be taken once daily, at bedtime. |
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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 ng/mL. |
| Enrollment, Month 3, Month 6 |
| 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 ng/mL. | Enrollment, Month 3, Month 6 |
| 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 ng/mL | Enrollment, Month 3, Month 6 |
| 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 ng/mL. | Enrollment, Month 3, Month 6 |
| 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 ng/mL | Enrollment, Month 3, Month 6 |
| Serum Concentration of Dichlorodiphenyldichloroethylene (DDE) | DDE is a chemical produced by the breakdown of dichlorodiphenyltrichloroethane (DDT). High levels of DDE can impact lactation and increase the risk of preterm birth. DDE concentration in serum is measured in ng/mL. | Enrollment, Month 3, Month 6 |
Participants randomized to take orlistat at the over-the-counter dose for six months. Diet and exercise plus a daily multivitamin were also recommended and monitored.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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 were also recommended and monitored. |
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| Primary | 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. | This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-five participants were not able to attend the Month 3 study visit in person; 23 due to the COVID-19 pandemic and an additional 2 due to other reasons. All of participants who were unable to have the in-person Month 3 visit provided a self-measured weight. Mean BMI calculated using weight measured per protocol and self-measured are reported separately. | Posted | Mean | Standard Deviation | kg/m^2 | Enrollment, Month 3, Month 6 |
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| Secondary | 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 nanograms per milliliter (ng/mL). | This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician. | Posted | Median | Inter-Quartile Range | ng/mL | Enrollment, Month 3, Month 6 |
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| Secondary | 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 ng/mL. | This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician. | Posted | Median | Inter-Quartile Range | ng/mL | Enrollment, Month 3, Month 6 |
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| Secondary | 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 ng/mL. | This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician. | Posted | Median | Inter-Quartile Range | ng/mL | Enrollment, Month 3, Month 6 |
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| Secondary | 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 ng/mL | This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician. | Posted | Median | Inter-Quartile Range | ng/mL | Enrollment, Month 3, Month 6 |
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| Secondary | 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 ng/mL. | This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician. | Posted | Median | Inter-Quartile Range | ng/mL | Enrollment, Month 3, Month 6 |
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| Secondary | 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 ng/mL | This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician. | Posted | Median | Inter-Quartile Range | ng/mL | Enrollment, Month 3, Month 6 |
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| Secondary | Serum Concentration of Dichlorodiphenyldichloroethylene (DDE) | DDE is a chemical produced by the breakdown of dichlorodiphenyltrichloroethane (DDT). High levels of DDE can impact lactation and increase the risk of preterm birth. DDE concentration in serum is measured in ng/mL. | This analysis includes participants who attended both the Enrollment and Month 3 visits, and also those who completed the Month 6 visit. Twenty-three participants were not able to attend the Month 3 study visit in person due to the COVID-19 pandemic and did not have blood drawn at this time point. An additional 2 participants did not attend the Month 3 visit in person and one had blood collected and shipped to the study lab by their physician. | Posted | Median | Inter-Quartile Range | ng/mL | Enrollment, Month 3, Month 6 |
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| 0 |
| 49 |
| 3 |
| 49 |
| 28 |
| 49 |
| EG001 | 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 were also recommended and monitored. | 0 | 51 | 0 | 51 | 41 | 51 |
| Hospitalization due to allergic reaction to an antibiotic | General disorders | Non-systematic Assessment |
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| Abdominal pain; masses on ovary, liver, and kidney; endometriosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Dizziness | General disorders | Non-systematic Assessment |
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| Diarrhea and frequent or oily bowel movements | Gastrointestinal disorders | Non-systematic Assessment |
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| Stomach ache or gassy | Gastrointestinal disorders | Non-systematic Assessment |
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| Cold/flu/respiratory symptoms | Infections and infestations | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | Non-systematic Assessment |
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| Falls | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Month 3 - BMI calculated with weight measured by study staff |
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