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

NCT07524244 | Recruiting

• 1 other identifier: BB2506RA-104
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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); Ulcerative Colitis (UC); Crohn's Disease (CD)

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

Outcome Measures

Primary Outcomes (2)

• Change in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36)

  The SF-36 consists of 8 subscales including: physical functioning, role limitations due to physical health (physical role functioning), role limitations due to emotional problems (emotional role functioning), vitality, mental health, social role functioning, bodily pain and general health. Scores for each subscale will be on a 0-100 scale with higher scores generally reflecting better health or less functional impairment for that respective subscale.

  From baseline to 24 weeks

• Change in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36)

  The SF-36 consists of 8 subscales including: physical functioning, role limitations due to physical health (physical role functioning), role limitations due to emotional problems (emotional role functioning), vitality, mental health, social role functioning, bodily pain and general health. Scores for each subscale will be on a 0-100 scale with higher scores generally reflecting better health or less functional impairment for that respective subscale.

  From baseline to 12 weeks

Secondary Outcomes (7)

• Change in Rheumatoid Arthritis Disease Activity Index-5 Questionnaire (RADAI-5)

  From baseline to 12 and 24 weeks

• Change in Routine Assessment of Patient Index Data (RAPID-3)

  From baseline to 12 and 24 weeks

• Change in Inflammatory Bowel Disease Symptom Inventory - Short Form (IBDSI-SF)

  From baseline to 12 and 24 weeks

• Change in fecal calprotectin

  From baseline to 12 and 24 weeks

• Change in immune and inflammatory serology

  From baseline to 12 and 24 weeks

Other Outcomes (4)

• Change in body composition (weight and BMI)

  From baseline to the end of the study intervention at 24 weeks

• Change in body composition (skeletal muscle mass)

  From baseline to the end of the study intervention at 24 weeks

• Change in body composition (body fat percentage)

  From baseline to the end of the study intervention at 24 weeks

Study Arms (7)

Ketogenic Diet 24 Weeks

EXPERIMENTAL

Participants with IBD or RA randomized initially to receive dietary counseling regarding the ketogenic diet for up to 24 weeks

Behavioral: Ketogenic diet

Carnivore (Lion) Diet 24 Weeks

EXPERIMENTAL

Participants with IBD or RA randomized initially to receive dietary counseling regarding the carnivore (lion) diet for up to 24 weeks

Behavioral: Carnivore (Lion) Diet

Wait List 12 Weeks

NO INTERVENTION

Participants with IBD or RA randomized initially to a 12 week waitlist who will continue their baseline dietary pattern WITHOUT specific dietary guidance/intervention

Carnivore (Lion) Diet for 12 weeks AFTER Wait-List

EXPERIMENTAL

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

Behavioral: Carnivore (Lion) Diet

Ketogenic Diet for 12 Weeks AFTER Wait-List

EXPERIMENTAL

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

Behavioral: Ketogenic diet

Voluntary Crossover - Ketogenic Diet to Carnivore (Lion) Diet AFTER 12 weeks

EXPERIMENTAL

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

Behavioral: Ketogenic diet; Behavioral: Carnivore (Lion) Diet

Voluntary Crossover - Carnivore (Lion) Diet to Ketogenic Diet AFTER 12 weeks

EXPERIMENTAL

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

Behavioral: Ketogenic diet; Behavioral: Carnivore (Lion) Diet

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.

Ketogenic Diet 24 Weeks; Ketogenic Diet for 12 Weeks AFTER Wait-List; Voluntary Crossover - Carnivore (Lion) Diet to Ketogenic Diet AFTER 12 weeks; Voluntary Crossover - Ketogenic Diet to Carnivore (Lion) Diet AFTER 12 weeks

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.

Carnivore (Lion) Diet 24 Weeks; Carnivore (Lion) Diet for 12 weeks AFTER Wait-List; Voluntary Crossover - Carnivore (Lion) Diet to Ketogenic Diet AFTER 12 weeks; Voluntary Crossover - Ketogenic Diet to Carnivore (Lion) Diet AFTER 12 weeks

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with medically verifiable IBD or medically verifiable RA
• Current personal residence in the continental U.S.
• Willingness and ability to follow dietary protocols

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuller Research Foundation: lead
• Resilient Roots: Functional Medicine: collaborator

Study Sites (1)

Resilient Roots: Functional Medicine

Charlottesville, Virginia, 22901, United States

RECRUITING

Related Links

• Detailed Study Description

MeSH Terms

Conditions

Arthritis, Rheumatoid; Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases; Autoimmune Diseases

Interventions

Diet, Ketogenic; Diet

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Robert D Abbott, MD

  Resilient Roots: Functional Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert D Abbott, MD

CONTACT

4342183425; info@resilientrootsfxevomed.com

Emily Palmer, MS, CNS

CONTACT

emily@resilientrootsfxevomed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are 2 planned randomizations. The first randomization will create 3 arms (ketogenic diet, carnivore \[lion\] diet and a wait-list control). The second randomization occurring after 12 weeks will apply ONLY to participants in the wait-list control group and will create 2 additional, but interventionally similar arms (wait-list -\> ketogenic diet and wait-list -\> carnivore \[lion\] diet). The final 2, additional arms are hypothetical, but distinct study arms that will be created at 12 weeks and voluntarily (no randomization) from participants of either the original ketogenic diet or carnivore \[lion\] diet intervention arms. Participants at 12 weeks can voluntarily elect to cross-over to the other dietary arm for the final 12 weeks of the study intervention (ketogenic diet -\> carnivore \[lion\] diet) or carnivore \[lion\] diet -\> ketogenic diet).

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 13, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)