NCT07524244Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 28 Mar 2026
- Start date
- 17 Feb 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Fuller Research Foundation
- NCT number
- NCT07524244
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 17 Feb 2026 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of blood transfusion in the previous 6 months
- On other medications outside of FDA approved medications
- Unable to complete, for any reason, the initial 3-week run-in period prior to the beginning of the formal study intervention
Other illness
- Individuals with Type 1 or Type II Diabetes on prescription medications including insulin
- History of strictures or fistula (IBD)
- Current initiation of disease modifying or biologic medication within the past 2 months
- 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
Age
- Outside of the age or BMI criteria
Other
- Inability to provide consent
- No medically definitive or verifiable diagnosis of IBD or RA
- Pregnancy
- 6 months Postpartum
- Breastfeeding
- Non-English Speaking
Who the study is looking for
- Diagnosed with medically verifiable IBD or medically verifiable RA
- Current personal residence in the continental U.S.
- Willingness and ability to follow dietary protocols
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Resilient Roots: Functional Medicine Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.