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RECRUITING Not applicable ClinicalTrials.gov

Ketogenic and Carnivore (Lion) Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis

Sponsor: Fuller Research Foundation • ClinicalTrials.gov ID: NCT07524244

Registry updated: 2026-10-05
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Description

This study is a randomized controlled clinical trial evaluating whether two therapeutic dietary approaches - a ketogenic diet and a carnivore (lion) diet - can improve quality of life, reduce symptoms, and influence measures of disease activity in adults with inflammatory bowel disease \[ulcerative colitis and Crohn's disease\] (IBD) or rheumatoid arthritis (RA). Participants will be randomized into one of three groups: 1) Ketogenic Diet, 2) Carnivore (Lion) Diet or 3) Wait-List Control. Participants randomized to a dietary group (ketogenic diet or carnivore diet) will be provided guidance on their specific dietary therapy and answer questions about their symptoms and quality of life at different intervals over a 24 week period. Participants will also complete laboratory testing at different intervals to assess for changes in nutritional status, cardiometabolic health and markers of immune activation and inflammation. Participants initially placed on the wait-list group will be asked similar questions about their symptoms and quality of life and complete the same laboratory testing as participants in a dietary group. Participants on the wait list will then be compared to participants following a specific dietary pattern to assess for any differences between the 2 groups. After 12 weeks, participants on the wait list will be randomized to a dietary group (ketogenic diet or carnivore diet) and followed in a similar fashion for an additional 12 week period.

Interventions

  • Ketogenic diet (Behavioral)
    The ketogenic diet is a high fat, moderate protein, and very low carbohydrate nutritional approach designed to shift the body's primary energy source from glucose to ketones, compounds produced in the liver from fat metabolism. This state of nutritional ketosis typically occurs when carbohydrate intake is restricted to 20-50 grams per day, though the exact threshold varies based on individual factors such as muscle mass, insulin sensitivity, and physical activity. Participants will receive nutritional guidance for the ketogenic diet in a virtual setting via both synchronous and asynchronous engagement including group telehealth sessions, dietary education guides/food lists, quantitative sample meals plans and ongoing messaging capacity with the clinical team for the duration of the dietary intervention.
  • Carnivore (Lion) Diet (Behavioral)
    The carnivore (lion) diet is a more restrictive form of a ketogenic diet that is intended as an elimination dietary protocol composed exclusively of ruminant meats (beef, lamb, bison, venison, goat, moose, elk), salt, and water. A broader carnivore diet includes more animal foods such as additional meats, fish, eggs, and some dairy. It excludes, however, all plant foods including vegetables, fruits, grains, legumes, nuts, seeds, or plant-derived oils. Participants will receive nutritional guidance for the carnivore (lion) and the broader carnivore diet in a virtual setting via both synchronous and asynchronous engagement including group telehealth sessions, dietary education guides/food lists, quantitative sample meals plans and ongoing messaging capacity with the clinical team for the duration of the dietary intervention.

Eligibility 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

Conditions

Rheumatoid Arthritis (RA) Crohn's Disease (CD) Ulcerative Colitis (UC)

Locations

  • Resilient Roots: Functional Medicine — Charlottesville, Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record