EICHORCondition: Rheumatoid Arthritis (RA) · Crohn's Disease (CD) · Ulcerative Colitis (UC) · Sponsor: Fuller Research Foundation
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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.
This description comes directly from the study's public registry record.
Robert D Abbott, MD · 4342183425 · info@resilientrootsfxevomed.com
Emily Palmer, MS, CNS · emily@resilientrootsfxevomed.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Resilient Roots: Functional Medicine | Charlottesville, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07524244