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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 64 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will complete certain study questionnaires around dietary adherence, progress and satisfaction at different 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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ketogenic and carnivore (lion) diets can improve daily life, symptoms, and signs of disease. It is for adults with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or rheumatoid arthritis, a disease that causes joint swelling. People are assigned by chance to a diet group or a waiting group during the 24-week study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of inflammatory bowel disease (IBD) or rheumatoid arthritis (RA).
  • Live in the continental United States.
  • Be willing and able to follow the study diet rules.

Who can't join

  • Cannot give consent, do not speak English, or cannot finish the 3-week preparation period before the study.
  • Do not meet the age or body mass index (BMI, a measure based on height and weight) rules, or do not have a confirmed IBD or RA diagnosis. The age and BMI limits are not listed.
  • Have type 1 or type 2 diabetes treated with prescription medicines, including insulin.
  • Have had narrowed bowel sections or abnormal tunnels from the bowel (fistulas), or received a blood transfusion in the past 6 months.
  • Are pregnant, within 6 months after giving birth, or breastfeeding.
  • Take medicines that are not FDA-approved, or started disease-modifying or biologic medicines to control the disease within the past 2 months.
  • Have organ failure, including heart, liver, or kidney failure or disease, or have had cancer within the past year.
  • Have a red meat allergy or alpha-gal allergy, which can cause reactions to red meat.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

VA