Personalized Lifestyle Intervention for Improving Functional Health Outcomes Using N-of-1 Tent-Umbrella-Bucket Design

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.

Conditions

• Health, Subjective
• Gastrointestinal Dysfunction
• Cardiovascular Risk Factor
• Autoimmune Diseases
• Dental Diseases
• Hormone Disturbance
• Neurocognitive Dysfunction

Interventions

DIETARY_SUPPLEMENT

Supplements and/or medical foods

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)

BEHAVIORAL

Behavioral change support program

Program to implement lifestyle and behavioral change according to individuals' need.

OTHER

Food plan

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)

Sponsors & Collaborators

• Tufts Medical Center

  collaborator OTHER

• MetaProteomics LLC

  collaborator INDUSTRY

• Metagenics, Inc.

  lead INDUSTRY

Principal Investigators

• Joseph Lamb, MD · Personalized Lifestyle Medicine Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-09-01

Primary Completion

2019-12-31

Completion

2022-12-31

Countries

• United States

Study Locations