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

NCT04007939 | Completed DMC

• 1 other identifier: PLX-PLMC
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (20)

• Height

  measured in meter (m)

  Baseline

• Weight

  measured in kilogram (kg)

  Baseline

• Body Mass index (BMI)

  BMI is measured in (weight in kilogram (kg)/ height in meter (m)\^2) outcome in double digits.

  Baseline

• Waist Circumference (WC)

  measured in centimeters (cm)

  Baseline

• Hip Circumference (HC)

  measured in cm

  Baseline

• Waist-to-Hip Ratio (WHR)

  WHR is numerical (0.00) and is and indicator for major health risk.

  Baseline

• Glucose

  Fasting glucose levels measured in blood in milligram/deciLiter (mg/dL)

  Baseline

• Total Cholesterol

  Fasting total cholesterol level is measured in serum in mg/dL

  Baseline

• Anti-Nuclear Antibodies (ANA)

  ANA is measured as a titer by serum dilution detects autoimmune disease.

  Baseline

• 25-hydroxy (OH) Vitamin D3

  25-OH vitamin D3 is measured in blood in nanogram/milliLiter (ng/mL) and detects deficiencies.

  Baseline

• High sensitivity C-Reactive Protein (Hs-CRP)

  Hs-CRP is measured in blood in mg/L detects inflammation.

  Baseline

• Homocysteine

  Homocysteine is measured in serum in micromol/Liter (µmol/L)

  Baseline

• Omega-3 Fatty Acids

  Omega-3 fatty acids: Eicosapentaenoic (EPA), Docosahexaenoic (DHA), and Docosapentaenoic (DPA) levels are measured in % weight.

  Baseline

• Beck Depression Inventory (BDI)

  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

  Baseline

• Beck Anxiety Inventory (BAI)

  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

  Baseline

• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Test

  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

  Baseline

• Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Test

  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

  Baseline

• Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form (SF)

  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

  Baseline

• Genomics

  DNA polymorphism measured using 23\&Me

  Baseline

• Stool

  Stool analysis measured by a stool analysis kit from American Gut

  Baseline

Study Arms (1)

Employee population

Subject comprised of employees of Metagenics but later will be expanded to those recruited from practitioner practices

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Employee health program inclusive of all gender and non-binary descriptions
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Metagenics, Inc.: lead
• MetaProteomics LLC: collaborator

Study Sites (1)

Personalized Lifestyle Medicine Center

Gig Harbor, Washington, 98332, United States

Location

MeSH Terms

Conditions

Autoimmune Diseases; Stomatognathic Diseases; Endocrine System Diseases; Cognition Disorders

Condition Hierarchy (Ancestors)

Immune System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Joseph Lamb, MD

  Personalized Lifestyle Medicine Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2019
• First Posted: July 5, 2019
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)