NCT07524244 · Fuller Research Foundation
Ketogenic and Carnivore (Lion) Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis
What this study is about
This study is a randomly assigned 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).
View original scientific description
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.
Interventions
BEHAVIORAL
Ketogenic diet
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.
BEHAVIORAL
Carnivore (Lion) Diet
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.
Primary outcome measures
Change in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36)
Time frame: From baseline to 24 weeks
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.
Change in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36)
Time frame: From baseline to 12 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Charlottesville, Virginia
Collaborators
Resilient Roots: Functional Medicine
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations