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Trial record 33 of 69 for:    ORLISTAT

Weight Loss Aid in an Exposed Population

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ClinicalTrials.gov Identifier: NCT03582722
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborators:
Healthway Compounding Pharmacy in central Michigan
Michigan Public Health Departments
Information provided by (Responsible Party):
Michele Marcus, Emory University

Brief Summary:
The study will explore whether if 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).

Condition or disease Intervention/treatment Phase
Polybrominated Biphenyl Poisoning Drug: Orlistat Drug: Placebo capsule Phase 1 Phase 2

Detailed Description:
Orlistat is an over-the-counter weight-loss aid that preferentially reduces body fat compared to diet and exercise alone. PBB is a Persistent Organic Pollutant (POP), characterized by a very long half-life and storage in adipose (fat) tissue.The study will explore whether if 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of a Weight Loss Aid in a Population Exposed to Polybrominated Biphenyls (PBB)
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat

Arm Intervention/treatment
Experimental: Weight loss aid
One-month supply of orlistat capsules (60mg) to be taken up to 3x daily with meals containing fat, daily multivitamins, and instructions for dietary modification and exercise for six months.
Drug: Orlistat
One-month supply of orlistat capsules (60mg) to be taken up to 3x daily with meals containing fat, daily multivitamins, and instructions for dietary modification and exercise for six months.
Other Name: Alli

Placebo Comparator: Placebo
One-month supply of placebo capsules to be taken up to 3x daily with meals containing fat, daily multivitamins, and instructions for dietary modification and exercise for six months.
Drug: Placebo capsule
One-month supply of placebo capsules to be taken up to 3x daily with meals containing fat, daily multivitamins, and instructions for dietary modification and exercise for six months.




Primary Outcome Measures :
  1. Change in weight [ Time Frame: Screening, 3 and 6 months follow up visits ]
    Participants will have their weight measured in light clothing without shoes on a regularly calibrated digital scale.

  2. Change in Body Mass Index [ Time Frame: Screening, 3 and 6 months follow up visits ]
    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 :
  1. Change in dietary intake using Automated Self-administered 24-hour Recall score [ Time Frame: Screening, 3 and 6 months follow up visits ]
    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.

  2. Change in physical activity [ Time Frame: Screening, 3 and 6 months follow up visits ]

    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 MET (metabolic equivalent) values for overall activity.

    METs will be calculated as outlined in Appendix 2 of this reference: Meyer AM, Evenson KR, Morimoto L, Siscovick D, White E: Test-retest reliability of the Women's Health Initiative physical activity questionnaire. Med Sci Sports Exerc 2009;41:530-538.

    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)


  3. Change in serum concentration of PBB (polybrominated biphenyl) 153 [ Time Frame: Screening, 3 and 6 months follow up visits ]
    PBB is an organic bromine compound that is environmentally toxic and is classified as a persistent organic pollutant. Blood samples will be collected, processed and stored. All three samples from a given individual will be analyzed in the same batch to minimize measurement error.

  4. Change in serum concentration of PBDE (Polybrominated diphenyl ether) 47 [ Time Frame: Screening, 3 and 6 months follow up visits ]
    PBDE is an organic bromine compound that is environmentally toxic and is classified as a persistent organic pollutant. Blood samples will be collected, processed and stored. All three samples from a given individual will be analyzed in the same batch to minimize measurement error.

  5. Change in serum concentration of PCB (polychlorinated biphenyl) 118 [ Time Frame: Screening, 3 and 6 months follow up visits ]
    PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. Blood samples will be collected, processed and stored. All three samples from a given individual will be analyzed in the same batch to minimize measurement error.

  6. Change in serum concentration of PCB (polychlorinated biphenyl) 138 [ Time Frame: Screening, 3 and 6 months follow up visits ]
    PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. Blood samples will be collected,

  7. Change in serum concentration of PCB (polychlorinated biphenyl) 153 [ Time Frame: Screening, 3 and 6 months follow up visits ]
    PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. Blood samples will be collected,

  8. Change in serum concentration of PCB (polychlorinated biphenyl) 180 [ Time Frame: Screening, 3 and 6 months follow up visits ]
    PCB is an organic chlorine compound that is environmentally toxic and is classified as a persistent organic pollutant. Blood samples will be collected,

  9. Change in serum concentration of DDT/DDE (Dichlorodiphenyldichloroethylene/Dichlorodiphenyltrichloroethane) [ Time Frame: Screening, 3 and 6 months follow up visits ]
    DDE is a chemical compound formed by dehydrohalogenation from DDT. Blood samples will be collected, processed and stored. All three samples from a given individual will be analyzed in the same batch to minimize measurement error.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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; serious chronic disease (e.g. uncontrolled diabetes, congestive heart failure, chronic kidney disease);
  • allergies to any ingredients of the Orlistat OTC capsules( Ingredients of Orlistat include the active ingredient, Orlistat, and the inactive ingredients, FD&C Blue No. 2, edible ink, gelatin, iron oxide, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, and titanium dioxide);
  • participants will become ineligible at any point during the study if they begin a medical regimen involving any of the above medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582722


Contacts
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Contact: Michele Marcus, PhD/MPH 404-727-8010 mmarcus@emory.edu
Contact: kristen marks, MPH

Locations
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United States, Georgia
Michele Marcus Recruiting
Atlanta, Georgia, United States, 30322
Contact: Michele Marcus, PhD/MPH    404-727-8010    mmarcus@emory.edu   
Sponsors and Collaborators
Emory University
Healthway Compounding Pharmacy in central Michigan
Michigan Public Health Departments
Investigators
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Principal Investigator: Michele Marcus, PhD/MPH School Of Public Health, Emory University

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Responsible Party: Michele Marcus, Professor, Emory University
ClinicalTrials.gov Identifier: NCT03582722     History of Changes
Other Study ID Numbers: IRB00099231
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michele Marcus, Emory University:
Polybrominated Biphenyl Exposure
Gastrointestinal lipase inhibitor
Additional relevant MeSH terms:
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Orlistat
Weight Loss
Poisoning
Body Weight Changes
Body Weight
Signs and Symptoms
Chemically-Induced Disorders
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents