RecruitingNot ApplicableNCT07524244

Ketogenic and 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


Sponsor

Fuller Research Foundation

Enrollment

160 participants

Start Date

Feb 17, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria3

  • 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 Criteria16

  • 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
  • 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

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Interventions

BEHAVIORALKetogenic diet

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.

BEHAVIORALCarnivore (Lion) Diet

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.


Locations(1)

Resilient Roots: Functional Medicine

Charlottesville, Virginia, United States

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NCT07524244


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