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Trial record 78 of 1734 for:    Recruiting, Not yet recruiting, Available Studies | Autoimmunity

Personal Lifestyle Engine (PLX) - Personal Lifestyle Medicine Center (PLMC)

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ClinicalTrials.gov Identifier: NCT04007939
Recruitment Status : Recruiting
First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Personalized Lifestyle Medicine Center
Information provided by (Responsible Party):
Metagenics, Inc.

Brief Summary:

It has been suggested that the best medicine should include four principles (4P) - Medicine should be personalized, predictive, preventative and participatory. Technology has provided the tools to collect data in ways not previously possible. Individuals can now collect information on their genome (including their genetic predisposition to tolerate medications and to respond to healthy lifestyle programs) that will modify their lifestyle and therapeutic choices. Beyond spot checks of vital signs and weight, individuals can now collect information on body composition, continuous monitoring of heart rate, blood pressure, and even blood sugar. Data on food consumption at a caloric, macronutrient and even micronutrient level can be collected. Standard medical histories and detailed physical examination findings and laboratory biomarkers can be correlated with this data.

Collections of individual patient data will need to be managed through computer programs and smart phone applications that provide direct feedback about the influence of lifestyle on health, wellness and biomarkers. To this end, Metagenics is designing and is launching a smart phone application, Personal Lifestyle Engine (PLX), for individual use by patients and their healthcare providers. The statistical analysis of these data is the primary objective of this study.


Condition or disease
Health, Subjective Gastrointestinal Dysfunction Cardiovascular Risk Factor Autoimmune Diseases Dental Diseases Hormone Disturbance Neurocognitive Dysfunction

Detailed Description:

Technology has led to a significant revisioning and modification of the models of medicine in practice today. It has been suggested that the best medicine should include four principles - Medicine should be personalized, predictive, preventative and participatory. This 4P medicine will thus be patient centered with a focus on the person who has the disease and not the disease the person has. It will be predictive as it identifies the preclinical trend/decline towards illness sooner than onset of symptoms that herald the loss of function and health. It will be preventative as the information gathered should offer opportunities to modify these trajectories towards illness and finally it will be participatory as individuals will be intimately involved in the gathering of data to identify trends and in the application of lifestyle measures to improve the quality of their life.

Technology has provided the tools to collect data in ways not previously possible. Individuals can now collect information on their genome (including their genetic predisposition to tolerate medications and to respond to healthy lifestyle programs) that will modify their lifestyle and therapeutic choices. Beyond spot checks of vital signs and weight, individuals can now collect information on body composition, continuous monitoring of heart rate, blood pressure, and even blood sugar. Data on food consumption at a caloric, macronutrient and even micronutrient level can be collected. Standard medical histories and detailed physical examination findings and laboratory biomarkers can be correlated with this data.

As has been noted in the Nathan Price et al. article, "A wellness study of 108 individuals using personal, dense, dynamic data clouds" (PMID: 28714965), a significant challenge to the effective use of these complex sets of individual patient data is how to define the boundaries between disease, average health and optimal wellbeing. To meet this challenge, compiling and analyzing collections of de-identified, detailed patient histories, questionnaires regarding symptoms and general condition, and associated objective findings (genomic data, vital signs, and physical exam and laboratory biomarkers) will theoretically identify these boundaries and will facilitate the deliverance of 4P Medicine. Comprehensive data collections on each subject evaluated in aggregate provides a diversity of uniqueness markers that can be statistically probed to identify patterns that predict wellbeing and perhaps individual response to lifestyle interventions.

An additional challenge for both the patient and their health care provider in 2018 and beyond is how to manage this data in an effective manner. Collections of individual patient data will need to be managed through computer programs and smart phone applications that provide direct feedback about the influence of lifestyle on health, wellness and biomarkers. To this end, Metagenics is designing and is launching a smart phone application, PLX, for individual use by patients and their healthcare providers. After and while a statistical analysis of this data set has been/is being completed, the data set will also be used in an initial beta test of the PLX operating system. The PLX application will not be used to conduct the statistical analysis which is the primary objective of this study."


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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Personal Lifestyle Engine (PLX) is an Employee Wellness Platform and App Used at the Personal Lifestyle Medicine Center (PLMC). This Study Examines Correlations Between Lifestyle Factors, Genomic Data, Physical Exam Finding and Biomarkers
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort
Employee population
Subject comprised of employees of Metagenics but later will be expanded to those recruited from practitioner practices



Primary Outcome Measures :
  1. Height [ Time Frame: Baseline ]
    measured in meter (m)

  2. Weight [ Time Frame: Baseline ]
    measured in kilogram (kg)

  3. Body Mass index (BMI) [ Time Frame: Baseline ]
    BMI is measured in (weight in kilogram (kg)/ height in meter (m)^2) outcome in double digits.

  4. Waist Circumference (WC) [ Time Frame: Baseline ]
    measured in centimeters (cm)

  5. Hip Circumference (HC) [ Time Frame: Baseline ]
    measured in cm

  6. Waist-to-Hip Ratio (WHR) [ Time Frame: Baseline ]
    WHR is numerical (0.00) and is and indicator for major health risk.

  7. Glucose [ Time Frame: Baseline ]
    Fasting glucose levels measured in blood in milligram/deciLiter (mg/dL)

  8. Total Cholesterol [ Time Frame: Baseline ]
    Fasting total cholesterol level is measured in serum in mg/dL

  9. Anti-Nuclear Antibodies (ANA) [ Time Frame: Baseline ]
    ANA is measured as a titer by serum dilution detects autoimmune disease.

  10. 25-hydroxy (OH) Vitamin D3 [ Time Frame: Baseline ]
    25-OH vitamin D3 is measured in blood in nanogram/milliLiter (ng/mL) and detects deficiencies.

  11. High sensitivity C-Reactive Protein (Hs-CRP) [ Time Frame: Baseline ]
    Hs-CRP is measured in blood in mg/L detects inflammation.

  12. Homocysteine [ Time Frame: Baseline ]
    Homocysteine is measured in serum in micromol/Liter (µmol/L)

  13. Omega-3 Fatty Acids [ Time Frame: Baseline ]
    Omega-3 fatty acids: Eicosapentaenoic (EPA), Docosahexaenoic (DHA), and Docosapentaenoic (DPA) levels are measured in % weight.

  14. Beck Depression Inventory (BDI) [ Time Frame: Baseline ]
    BDI is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Rating system: 1-10: These ups and downs are considered normal; 11-16: Mild mood disturbance; 17-20: Borderline clinical depression; 21-30: Severe depression; over 40: Extreme depression

  15. Beck Anxiety Inventory (BAI) [ Time Frame: Baseline ]

    BAI is a multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults.The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs[4] are:

    0-7: minimal anxiety 8-15: mild anxiety 16-25: moderate anxiety 26-63: severe anxiety


  16. Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Test [ Time Frame: Baseline ]
    PROMIS Sleep Disturbance Test is a self-scored test to identify sleep disturbance. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. The T-scores are interpreted as follows: Less than 55 = None to slight 55.0—59.9 = Mild 60.0—69.9 = Moderate 70 and over = Severe

  17. Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Test [ Time Frame: Baseline ]
    PROMIS Anxiety test is a 7-item questionnaire that assesses the pure domain of anxiety in individuals age 18 and older. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. The T-scores are interpreted as follows: Less than 55 = None to slight 55.0—59.9 = Mild 60.0—69.9 = Moderate 70 and over = Severe

  18. Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form (SF) [ Time Frame: Baseline ]
    PROMIS Depression SF is an 8-item questionnaire that assesses the pure domain of depression in individuals age 18 and older. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.The T-scores are interpreted as follows: Less than 55 = None to slight 55.0—59.9 = Mild 60.0—69.9 = Moderate 70 and over = Severe

  19. Genomics [ Time Frame: Baseline ]
    DNA polymorphism measured using 23&Me

  20. Stool [ Time Frame: Baseline ]
    Stool analysis measured by a stool analysis kit from American Gut



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Employee health program inclusive of all gender and non-binary descriptions
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited first from Metagenics employees but expand to family members of employees and from the general population. It is expected that subjects will be recruited from the private practices of both Study Investigators and associated clinical staff.
Criteria

Inclusion Criteria:

  • Male or Female
  • Ages 18-80, inclusive
  • Willing to give written informed consent to participate in the study

Exclusion Criteria:

  • A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic, or hematologic disease.
  • Known infection with human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B or C.
  • Inability to comply with study and/or follow-up visits.
  • Any concurrent condition (including clinically significant abnormalities in medical history, physical examination or laboratory evaluations) which, in the opinion of the Principle Investigator (PI), would preclude safe participation in this study or interfere with compliance.
  • Any sound medical, psychiatric and/or social reason which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance.

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): NCT04007939


Contacts
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Contact: Joseph Lamb, MD 253-853-7233 josephlamb@plmc.com
Contact: Lincoln Bouillon, MS, MBA 253-853-7260 lincolnbouillon@metagenics.com

Locations
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United States, Washington
Personalized Lifestyle Medicine Center Recruiting
Gig Harbor, Washington, United States, 98332
Contact: Lincoln Bouillon, MS, MBA    253-853-7260    lincolnbouillon@metagenics.com   
Contact: Kim Koch, CMA    253-853-7291    kimkoch@metagenics.com   
Sub-Investigator: Michael Stone, MD         
Sub-Investigator: Deanna Minich, PhD         
Sponsors and Collaborators
Metagenics, Inc.
Personalized Lifestyle Medicine Center
Investigators
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Principal Investigator: Joseph Lamb, MD Personalized Lifestyle Medicine Center

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Responsible Party: Metagenics, Inc.
ClinicalTrials.gov Identifier: NCT04007939     History of Changes
Other Study ID Numbers: PLX-PLMC
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Metagenics, Inc.:
wellness
personalized medicine
functional medicine
4P medicine
employee wellness program
functional capacity
smart phone application
Additional relevant MeSH terms:
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Autoimmune Diseases
Cognitive Dysfunction
Stomatognathic Diseases
Endocrine System Diseases
Immune System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders