NCT04005456: LIFE-HOUSE

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

Completed NA Last updated 30 October 2023

What this trial tests

NA trial testing Supplements and/or medical foods in Health, Subjective in 400 participants. Completed in 31 December 2022.

Timeline

1 September 2018

Primary endpoint
31 December 2019

31 December 2022

Quick facts

Lead sponsor	Metagenics, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	400
Start date	1 September 2018
Primary completion	31 December 2019
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Supplements and/or medical foods
• Behavioral change support program
• Food plan

Conditions studied

• Health, Subjective — all drugs for Health, Subjective →
• Gastrointestinal Dysfunction — all drugs for Gastrointestinal Dysfunction →
• Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →
• Autoimmune Diseases — all drugs for Autoimmune Diseases →

Sponsor

Metagenics, Inc.

Who can join

Adults 18 to 80, any sex, with Health, Subjective or Gastrointestinal Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Perspective: Application of N-of-1 Methods in Personalized Nutrition Research.
   Potter T, Vieira R, de Roos B. · · 2021 · cited 27× · PMID 33460438 · DOI 10.1093/advances/nmaa173
2. Personalized Lifestyle Intervention and Functional Evaluation Health Outcomes SurvEy: Presentation of the LIFEHOUSE Study Using N-of-One Tent-Umbrella-Bucket Design.
   Lamb JJ, Stone M, D'Adamo CR, Volkov A, et al · · 2022 · cited 10× · PMID 35055430 · DOI 10.3390/jpm12010115
3. Pro-resolving lipid mediators in diseases: exploring the molecular basis and clinical implication.
   Li C, Wang Z, Yang Y, Jiang Q, et al · · 2026 · PMID 41486400 · DOI 10.1186/s43556-025-00400-5
4. LIFEHOUSE's Functional Nutrition Examination (Physical Exam, Anthropometrics, and Selected Biomarkers) Informs Personalized Wellness Interventions.
   Stone M, Lukaczer D, D'Adamo CR, Dotson N, et al · · 2023 · PMID 37108980 · DOI 10.3390/jpm13040594