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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Fuller Research Foundation
Study ID
NCT07524244
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Feb 17, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ketogenic Diet 24 Weeks
    Participants with IBD or RA randomized initially to receive dietary counseling regarding the ketogenic diet for up to 24 weeks
  • Experimental: Carnivore (Lion) Diet 24 Weeks
    Participants with IBD or RA randomized initially to receive dietary counseling regarding the carnivore (lion) diet for up to 24 weeks
  • No Intervention: Wait List 12 Weeks
    Participants with IBD or RA randomized initially to a 12 week waitlist who will continue their baseline dietary pattern WITHOUT specific dietary guidance/intervention
  • Experimental: Carnivore (Lion) Diet for 12 weeks AFTER Wait-List
    Participants with IBD or RA randomized initially to the wait-list for 12 weeks who are then randomized to receive dietary counseling regarding the carnivore (lion) diet for a subsequent 12 weeks
  • Experimental: Ketogenic Diet for 12 Weeks AFTER Wait-List
    Participants with IBD or RA randomized initially to the wait-list for 12 weeks who are then randomized to receive dietary counseling regarding the carnivore (lion) diet for a subsequent 12 weeks
  • Experimental: Voluntary Crossover - Ketogenic Diet to Carnivore (Lion) Diet AFTER 12 weeks
    Participants with IBD or RA randomized initially to the ketogenic diet for 12 weeks who voluntarily choose to crossover to the carnivore (lion) diet intervention for the final 12 weeks
  • Experimental: Voluntary Crossover - Carnivore (Lion) Diet to Ketogenic Diet AFTER 12 weeks
    Participants with IBD or RA randomized initially to the carnivore (lion) diet for 12 weeks who voluntarily choose to crossover to the ketogenic diet intervention for the final 12 weeks

Primary Outcome Measure

Change in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36) [ Time Frame: From baseline to 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Resilient Roots: Functional MedicineCharlottesvilleVirginia22901
Robert D Abbott, MD
[email protected]
4342183425
Emily Palmer, CNS
[email protected]
4342183425
Robert D Abbott, MD (PRINCIPAL_INVESTIGATOR)

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