Recruiting

Ketogenic & Carnivore

Sponsor:

Fuller Research Foundation

Code:

NCT07524244

Conditions

Rheumatoid Arthritis (RA)

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Ketogenic diet

Carnivore (Lion) Diet

Study Details

Brief 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.

Conditions

Rheumatoid Arthritis (RA)

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Study ID

NCT07524244

Start date

Feb 17, 2026

Status verified date

Apr, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Ketogenic 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.

Carnivore (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.

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 ]
  • Change in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36) [ Time Frame: From baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Robert D Abbott, MD

4342183425info@resilientrootsfxevomed.com

Emily Palmer, MS, CNS

emily@resilientrootsfxevomed.com

Locations

Resilient Roots: Functional Medicine

Recruiting

Charlottesville, Virginia, United States, 22901

Contacts

Robert D Abbott, MD

4342183425info@resilientrootsfxevomed.com

Emily Palmer, CNS

4342183425info@resilientrootsfxevomed.com

Principal Investigator:

Robert D Abbott, MD

More Information

Sponsor

Fuller Research Foundation

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • ketogenic diet
  • carnivore diet
  • rheumatoid arthritis
  • inflammatory bowel disease
  • ulcerative colitis
  • crohn's disease
  • autoimmunity
  • randomized controlled trial
  • dietary intervention
  • lion diet
  • nutritional therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fuller Research Foundation on 2026-04-16.