Overview
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.
Description
The primary goal of this study is to determine whether ketogenic or carnivore dietary therapy improves, health-related quality of life, disease specific symptom burden or objective inflammatory markers in patients with a history of IBD or RA.
Given the limited prospective data on carnivore (lion) diet approaches for addressing autoimmune conditions, the study aims to assess feasibility of implementation as well as overall safety including the documentation of common adverse events, changes to nutritional status or changes to cardiometabolic status including blood lipids.
Total participation time is approximately 27 weeks including a 3-week baseline run-in and a 24-week dietary intervention period divided into 2, 12-week phases.
Randomization and 3 week run-in period
Participants will be randomized in a 2-2-2 schema, stratified by disease state (IBD or RA), to the carnivore (lion) diet, ketogenic diet, or placed on a wait-list. Participants will receive an at-home blood ketone and blood glucose monitoring device and a digital body composition scale. Participants will discontinue any supplements started within one month of study enrollment.
Participants will then complete questionnaires and laboratory testing across several areas to include:
Baseline quality-of-life, psychometric, and disease-specific symptom questionnaires Baseline body composition assessment and a historical food frequency questionnaire Baseline qualitative and quantitative analysis of self reported dietary intake Baseline at-home finger-stick blood ketone and blood glucose monitoring Baseline fasted blood collection and at-home stool collection
Initial dietary intervention and support
Participants randomized into a dietary intervention group will receive educational materials, including recommended foods and structured meal plans, with ongoing virtual access to medical and nutrition providers. Participants will join scheduled group telehealth sessions tailored to their dietary intervention to review study procedures, ask questions, and receive support within a community of fellow participants. Participants will receive ongoing telehealth monitoring from the medical and nutritional staff.
Participants will complete certain study questionnaires around dietary adherence, progress and satisfaction at different intervals throughout the study. Participants will also also complete qualitative and quantitative dietary journals alongside at home blood ketone and blood glucose at various intervals throughout the study.
Midpoint questionnaires and testing
After the first 12 weeks of their specified dietary intervention, participants will complete questionnaires and testing similar to their baseline to assess for any initial changes. Participants initially placed on the wait-list will be asked similar questions about their symptoms and quality of life and complete the same laboratory testing as participants in a dietary group for the purposes of comparison at 12 weeks.
Following the completion of their midpoint testing, participants on the wait list will be randomized to a dietary group (ketogenic diet or carnivore diet) and complete the same initial 12 week dietary program as those originally randomized to a dietary group. Individuals in the original dietary groups will continue for an additional 12 weeks in their specified dietary interventions OR voluntarily elect to "cross-over" into the other dietary intervention arm with the approval of the clinical team. Participants in either dietary intervention group will continue to receive ongoing support, education and virtual access to the medical and nutritional team.
Final Questionnaires and Testing
After 24 weeks (2, 12 week dietary phases), all study participants will repeat baseline study questionnaires and laboratory testing for the sake of comparison of key outcome measures at 24 weeks.
Eligibility
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
