Clinical trial NCT04007939: Personal Lifestyle Engine (PLX) - Personal Lifestyle Medicine Center (PLMC)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health, Subjective
Gastrointestinal Dysfunction
Cardiovascular Risk Factor
Autoimmune Diseases
Dental Diseases
Hormone Disturbance
Neurocognitive Dysfunction
Keywords: wellness
personalized medicine
functional medicine
4P medicine
employee wellness program
functional capacity
smart phone application
Lead sponsor: Metagenics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: MetaProteomics LLC
First posted: 2019-07-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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."

Eligibility 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.

Primary outcomes:
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Body Mass index (BMI)
timeFrame: Baseline
measure: Waist Circumference (WC)
timeFrame: Baseline
measure: Hip Circumference (HC)
timeFrame: Baseline
measure: Waist-to-Hip Ratio (WHR)
timeFrame: Baseline
measure: Glucose
timeFrame: Baseline
measure: Total Cholesterol
timeFrame: Baseline
measure: Anti-Nuclear Antibodies (ANA)
timeFrame: Baseline
measure: 25-hydroxy (OH) Vitamin D3
timeFrame: Baseline
measure: High sensitivity C-Reactive Protein (Hs-CRP)
timeFrame: Baseline
measure: Homocysteine
timeFrame: Baseline
measure: Omega-3 Fatty Acids
timeFrame: Baseline
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Test
timeFrame: Baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Test
timeFrame: Baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form (SF)
timeFrame: Baseline
measure: Genomics
timeFrame: Baseline
measure: Stool
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gig Harbor
country: United States
facility: Personalized Lifestyle Medicine Center
state: Washington
Study officials:
affiliation: Personalized Lifestyle Medicine Center
name: Joseph Lamb, MD
role: PRINCIPAL_INVESTIGATOR
References: