Actively Recruiting
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
Led by Fuller Research Foundation · Updated on 2026-04-16
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fuller Research Foundation
Lead Sponsor
R
Resilient Roots: Functional Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether two specific diets — the ketogenic diet and the carnivore (lion) diet — can improve quality of life, reduce symptoms, and affect disease activity in adults with inflammatory bowel disease (including ulcerative colitis and Crohn's disease) or rheumatoid arthritis. This randomized controlled clinical trial aims to assess how these dietary approaches influence health and inflammation over time in these patients. Participants will be randomly assigned to one of three groups: the ketogenic diet group, the carnivore (lion) diet group, or a wait-list control group. Those in the dietary groups will receive virtual guidance, educational materials, structured meal plans, and ongoing support from medical and nutrition providers through telehealth sessions over a 24-week period divided into two 12-week phases. The wait-list group will continue their usual diet for 12 weeks and then be randomized to one of the dietary interventions. Participants may also choose to switch diets after the first 12 weeks with clinical team approval. Throughout the study, participants will complete questionnaires about quality of life, symptoms, and diet adherence. They will also perform at-home blood ketone and glucose monitoring, and undergo laboratory tests to evaluate nutritional status, cardiometabolic health, immune activity, and inflammation. Assessments occur at baseline, midpoint (12 weeks), and study completion (24 weeks). Total participation lasts about 27 weeks, including a 3-week run-in period before starting the diet interventions.
CONDITIONS
Brief Title
Ketogenic and Carnivore (Lion) Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with medically verifiable inflammatory bowel disease or rheumatoid arthritis
- Current personal residence in the continental United States
- Willingness and ability to follow dietary protocols
You will not qualify if you...
- Unable to provide consent
- Diagnosis of type 1 or type 2 diabetes treated with prescription medications including insulin
- Outside of the age or BMI criteria
- No medically definitive or verifiable diagnosis of inflammatory bowel disease or rheumatoid arthritis
- History of strictures or fistula in inflammatory bowel disease
- History of blood transfusion in the previous 6 months
- Pregnancy
- Within 6 months postpartum
- Breastfeeding
- Use of medications outside of FDA approved medications
- Initiation of disease modifying or biologic medication within the past 2 months
- Unable to complete the initial 3-week run-in period
- Non-English speaking
- Organ failure including heart, liver, or kidney failure or disease
- History of malignancy within the last year
- Allergy to red meat or alpha-gal allergy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants complete a 3-week baseline run-in period including questionnaires, laboratory testing, and baseline monitoring of blood ketones and blood glucose at home.
Baseline assessments and at-home monitoring
Duration - 24 weeks total divided into 2 phases of 12 weeks each
Participants follow either the ketogenic diet or the carnivore (lion) diet with nutritional guidance, group telehealth sessions, and ongoing virtual support from medical and nutrition providers. Participants complete questionnaires, dietary journals, and at-home blood monitoring throughout the intervention. Participants initially on a wait-list undergo a 12-week wait period before starting dietary intervention.
Group telehealth sessions and virtual monitoring throughout; questionnaires and testing at baseline, 12 weeks, and 24 weeks
Trial Site Locations
Total: 1 location
1
Resilient Roots: Functional Medicine
Charlottesville, Virginia, United States, 22901
Actively Recruiting
Research Team
R
Robert D Abbott, MD
E
Emily Palmer, MS, CNS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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