Ketogenic versus Carnivore (Lion) diets for inflammatory bowel disease and rheumatoid arthritis
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
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Fuller Research Foundation Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT07524244 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Charlottesville, Virginia
- Resilient Roots: Functional Medicine — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Robert D Abbott, MD — Resilient Roots: Functional Medicine
- Study coordinator: Robert D Abbott, MD
- Email: info@resilientrootsfxevomed.com
- Phone: 4342183425
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.