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NCT04005456 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Metagenics.

Completed
Registry status
NA
Development phase
400
Enrollment target

NCT04005456: Completed NA study, sponsored by Metagenics.

NCT04005456 is a NA study that has completed, run by Metagenics. The registered enrollment target is 400 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04005456, a NA study, has completed, sponsored by Metagenics.

COMPLETED
Registry status
NA
Development phase
400 participants
Enrollment target

Study 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.

Primary Outcome

The MOS SF-36 is an indicator of overall health status. It has an eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability.

Interventions

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

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2018-09-01
Est. Completion 2022-12-31
Phase NA
Metagenics

7 total trials

What the finished NCT04005456 record still lists

NCT04005456 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 3 interventions - of which Supplements and/or medical foods is the first listed.

NCT04005456 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04005456 about?

NCT04005456 is a clinical study titled "Personalized Lifestyle Intervention for Improving Functional Health Outcomes Using N-of-1 Tent-Umbrella-Bucket Design". 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-Bu...

What is the current status of trial NCT04005456?

This trial is currently completed. It is a NA study. The enrollment target is 400 participants. The study started on 2018-09-01. Estimated completion is 2022-12-31.

What interventions are being tested in trial NCT04005456?

The interventions under investigation include: Supplements and/or medical foods (DIETARY_SUPPLEMENT), Behavioral change support program (BEHAVIORAL), Food plan (OTHER).

Who is sponsoring clinical trial NCT04005456?

This trial is sponsored by Metagenics, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04005456's enrollment target sits among peer trials

400 246th of 2000 higher than 1,734 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04005456, the US trial registry maintained by the National Library of Medicine. NCT04005456 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.