Personalized Lifestyle Intervention for Improving Functional Health Outcomes Using N-of-1 Tent-Umbrella-Bucket Design
Condition: Health, Subjective; Gastrointestinal Dysfunction; Cardiovascular Risk Factor; Autoimmune Diseases; Dental Diseases; Hormone Disturbance; Neurocognitive Dysfunction
MeSH terms: Stomatognathic Diseases; Endocrine System Diseases; Autoimmune Diseases; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The LIFE-HOUSE research project is designed to evaluate the impact of a personalized
      lifestyle intervention program on functional capacity as an approach to quantitating health,
      and its relationship to well understood disease risk determinants.

      LIFE-HOUSE will utilize an innovative Tent-Umbrella-Bucket design.

      Participants will gather under the Tent of an all-inclusive 'N of 1' Case Series providing a
      shelter of Functional Medicine interventions against the storm of chronic disease. Under this
      Tent are a collection of Umbrellas where participants with similar clinical challenges are
      evaluated as clinically defined groups with loose guidelines for the planned interventions.
      Finally, participants standing under these Umbrellas may step into specific Buckets that
      gather individuals with nearly identical clinical presentations into more formally described
      prescriptive randomized arms for intervention.

      Individuals will be offered the opportunity to participate in all Umbrellas and Buckets for
      which they qualify. They may accept or reject participation in any Umbrella or Bucket and yet
      remain eligible for participation in the overall Tent.
    

Detailed description: 
      It has been suggested that the best medicine should value four principles (4P) - medicine
      should be personalized, predictive, preventative and participatory. This 4P Medicine will
      thus be personalized and 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 pre-clinical
      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 their lives.

      There is a significant unmet need to identify the value of a personalized lifestyle
      intervention program for improving functional health outcomes. Whereas disease is well
      understood from traditional pathology-based indices, health is less easily defined.
      Historically, healthy has been the default term that is applied to an individual who is not
      recognized as having a disease. This definition of health as the absence of disease has
      resulted in the delivery of health and wellness as often lying outside the purview of
      medicine.

      An evolving definition of health, however, is to recognize that it is related to the
      functional capacity of the individual. Functional capacity can be categorized in four
      assessment areas: physiological, physical, cognitive and emotional. All four of these
      subcategories are quantifiable by both qualitative and quantitative metrics. The effects on
      health of a multi-modal personalized lifestyle medicine intervention program can best be
      evaluated by using functional determinants.

      Functional Medicine is an integrative medicine philosophy that uniquely incorporates 4P
      Medicine with a focus on function and dysfunction and the necessity to consider the
      physiological events that determine the balance between the two. The LIFE-HOUSE research
      project is designed to evaluate the impact of a personalized lifestyle intervention program
      on functional capacity as an approach to quantitating health, and its relationship to well
      understood disease risk determinants.

      Individuals will be offered the opportunity to participate in all Umbrellas and Buckets for
      which they qualify. They may accept or reject participation in any Umbrella or Bucket and yet
      remain eligible for participation in the overall Tent. Due to the structure of the uniquely
      defined yet overlapping system of Umbrellas and Buckets, a specific Subject may participate
      consecutively and/or sequentially in a series of Umbrella and Buckets as applicable and their
      data may be included in multiple Umbrella and Bucket analyses.
    

Intervention name(s): Supplements and/or medical foods; Behavioral change support program; Food plan
Intervention type(s): Dietary Supplement; Behavioral; Other
Intervention description(s): Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients); Program to implement lifestyle and behavioral change according to individuals' need.; Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: wellness; n-of-1 trial; detoxification; personalized medicine; functional medicine; 4P medicine; lifestyle medicine; homocysteine; dietary supplement; medical food; behavioral change; lifestyle modification; employee wellness program; functional capacity; food plan