MVNI / IRB FAST

A proposed human-performance feasibility program.

A planning-stage effort to determine whether a scientifically defensible, medically governed study can be built—not a public invitation to experiment.

THE QUESTION

Can a narrow, testable protocol produce credible information about nutrition, lean tissue, cognition, and performance?

The defensible protocol, endpoints, duration, safety plan, analysis, and regulatory classification must be established with qualified scientific and institutional owners. Founder preference does not substitute for independent review.

Terminology matters.

This may ultimately be classified as a single-participant prospective feasibility study rather than a classical N-of-1 trial. The investigator and biostatistician will decide.

CURRENT GATE

Pre-intervention de-risking and institutional acquisition.

  1. Clinical feasibility
    Obtain qualified medical review and a referral pathway.
  2. Scientific ownership
    Secure an investigator, biostatistical input, and an institutional home.
  3. Protocol redesign
    Define endpoints, measurements, stopping criteria, refeeding, and analysis.
  4. Independent review
    Complete institutional regulatory and ethics determinations.
  5. Activation
    Begin only after all approvals, contracts, systems, and clinical owners are in place.

FOR INVESTIGATORS

The ask is a feasibility critique—not an endorsement.

We are seeking a qualified investigator or institutional referral willing to assess whether a defensible version belongs in an academic or clinical research environment.