Clinical trial Recruiting at 1 site Interventional Ages 18 to 64

Ketogenic versus Carnivore (Lion) diets for inflammatory bowel disease and rheumatoid arthritis

Official title: Effectiveness and Efficacy of a Ketogenic or Carnivore (Lion) Diet for Quality Life and Symptom Burden in Individuals With Symptomatic Inflammatory Bowel Disease or Rheumatoid Arthritis: A Randomized Controlled Clinical Trial

Run by Fuller Research Foundation · NCT07524244 · Data updated 2026-11-12

This trial will test whether a ketogenic diet or a carnivore (lion) diet can reduce symptoms, improve quality of life, and lower inflammation in adults with IBD or rheumatoid arthritis.

More Rheumatoid Arthritis (RA) trials

Quick facts

Study typeInterventional
Ages18 Years to 64 Years
SexAll
Enrollment160 (estimated)
SponsorFuller Research Foundation
Academic / other
Locations1 site (Charlottesville, Virginia)
StatusRecruiting
StartedFebruary 17, 2026
Main results expectedSeptember 2027
Study endsSeptember 2027
Registry record updatedOctober 5, 2026
Trial IDNCT07524244 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with a medically verifiable diagnosis of Crohn's disease, ulcerative colitis, or rheumatoid arthritis who live in the continental U.S. and are willing and able to follow the prescribed dietary protocols are ideal candidates.

Probably not a fit

People with recent strictures or fistula (for IBD), recent malignancy or organ failure, pregnancy or breastfeeding, those on insulin or other prescription diabetes medications, or those unable to adhere to the run-in or dietary requirements are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial assigns adults with medically verifiable IBD (Crohn's or ulcerative colitis) or rheumatoid arthritis to a ketogenic diet, a carnivore (lion) diet, or a wait-list control. After a 3-week run-in, participants follow their assigned diet for 24 weeks with remote support, at-home ketone and glucose monitoring, and a digital body composition scale. Questionnaires and periodic laboratory tests will track quality of life, disease-specific symptoms, nutritional status, cardiometabolic markers, and inflammatory/immune biomarkers. The study also documents safety, adverse events, and feasibility given the limited prospective data on carnivore diets.

Why it matters

Potential benefit: If successful, these dietary approaches could reduce symptom burden and improve quality of life and objective inflammation measures, offering additional non-drug options for people with IBD or RA.

How similar studies have gone: Small studies and case series suggest ketogenic diets may help metabolic and inflammatory markers, but prospectively collected data on carnivore diets for autoimmune conditions are very limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosed with medically verifiable IBD or medically verifiable RA
* Current personal residence in the continental U.S.
* Willingness and ability to follow dietary protocols

Exclusion Criteria:

* Inability to provide consent
* Individuals with Type 1 or Type II Diabetes on prescription medications including insulin
* Outside of the age or BMI criteria
* No medically definitive or verifiable diagnosis of IBD or RA
* History of strictures or fistula (IBD)
* History of blood transfusion in the previous 6 months
* Pregnancy
* 6 months Postpartum
* Breastfeeding
* On other medications outside of FDA approved medications
* Current initiation of disease modifying or biologic medication within the past 2 months
* Unable to complete, for any reason, the initial 3-week run-in period prior to the beginning of the formal study intervention
* Non-English Speaking
* Organ failure of any kind including heart, liver and kidney failure or disease
* History of malignancy within the last year prior to enrollment
* Red meat allergy, alpha-gal allergy

Where it's running

  • Resilient Roots: Functional Medicine
    Charlottesville, Virginia, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.