160 Participants NeededMy employer runs this trial

Ketogenic and Carnivore Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis

RD
EP
Overseen ByEmily Palmer, MS, CNS
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Fuller Research Foundation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether two specific diets—the ketogenic diet and the carnivore (lion) diet—can alleviate symptoms and improve well-being for individuals with inflammatory bowel disease (IBD) or rheumatoid arthritis (RA). Participants will be divided into groups to follow one of these diets or remain on a wait-list before starting a diet. The trial aims to determine if these diets can enhance quality of life and reduce disease activity. Individuals diagnosed with IBD or RA and residing in the continental U.S. may be suitable candidates for this trial. As an unphased trial, it provides a unique opportunity for participants to explore innovative dietary approaches to managing their conditions.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have started new disease-modifying or biologic medications in the past 2 months. It's best to discuss your specific medications with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both ketogenic and carnivore diets might benefit individuals with inflammatory bowel disease (IBD) and rheumatoid arthritis (RA). In one report, 10 patients with IBD experienced improvement after trying these diets. However, concerns exist, particularly with the ketogenic diet. One study found it might worsen colitis (colon inflammation) by affecting gut bacteria and the immune system.

For the carnivore diet, results are mixed. Some studies suggest it might reduce inflammation and improve symptoms for certain individuals. However, experts caution against trying it without medical guidance due to its restrictive nature and potential long-term effects on gut health.

In summary, while these diets might assist some individuals, potential risks exist, especially for those with specific conditions. Consulting healthcare professionals before starting these diets is crucial to ensure they are safe and suitable for individual health needs.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the ketogenic and carnivore (lion) diets for inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) because these diets offer unique, non-pharmaceutical approaches to managing these conditions. Unlike standard treatments, which often involve medications like immunosuppressants and anti-inflammatory drugs, these diets focus on altering food intake to potentially reduce inflammation naturally. The ketogenic diet emphasizes high fat, moderate protein, and low carbohydrate intake, which may help modulate metabolic pathways linked to inflammation. The carnivore diet, on the other hand, focuses on consuming only animal-based foods, which might simplify digestion and reduce inflammatory triggers. These dietary interventions offer a fresh perspective by potentially minimizing side effects commonly associated with conventional medications.

What evidence suggests that this trial's dietary treatments could be effective for IBD and RA?

Research has shown that the ketogenic diet, one of the diets studied in this trial, might help reduce inflammation, benefiting conditions like inflammatory bowel disease (IBD) and rheumatoid arthritis (RA). Studies have found that this diet can lower certain inflammation markers linked to these conditions. The carnivore diet, another diet under investigation, also shows promise. Some reports suggest it might aid in weight loss and improve inflammation-related symptoms. Additionally, a series of patient cases with IBD showed improvement while following a mostly carnivore-ketogenic diet. These findings suggest that both diets could positively affect IBD and RA symptoms.12345

Who Is on the Research Team?

RD

Robert D Abbott, MD

Principal Investigator

Resilient Roots: Functional Medicine

Are You a Good Fit for This Trial?

This trial is for adults in the continental U.S. with a confirmed diagnosis of inflammatory bowel disease (Crohn's or ulcerative colitis) or rheumatoid arthritis, who can follow specific diets. People can't join if they're pregnant, breastfeeding, have certain allergies (like to red meat), recent cancer, organ failure, diabetes on medication, or other serious health issues.

Inclusion Criteria

Current personal residence in the continental U.S.
Willingness and ability to follow dietary protocols
I have a confirmed diagnosis of IBD or RA.

Exclusion Criteria

I have received a blood transfusion in the past 6 months.
Pregnancy
Outside of the age or BMI criteria
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

Baseline Run-in

Participants undergo baseline assessments including quality-of-life questionnaires, body composition analysis, and dietary intake evaluation

3 weeks
1 visit (in-person), ongoing at-home monitoring

Initial Dietary Intervention

Participants receive dietary counseling and follow a ketogenic or carnivore diet with ongoing virtual support and monitoring

12 weeks
Virtual visits and at-home monitoring

Midpoint Assessment

Participants complete midpoint questionnaires and testing to assess changes in symptoms and quality of life

1 week
1 visit (in-person or virtual)

Continued Dietary Intervention or Crossover

Participants continue their dietary intervention or crossover to the other diet with continued support

12 weeks
Virtual visits and at-home monitoring

Final Assessment

Participants repeat baseline assessments to compare key outcome measures at the end of the study

1 week
1 visit (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Carnivore (Lion) Diet
  • Ketogenic diet

Trial Overview

The study compares two special diets—a ketogenic diet and a carnivore (lion) diet—to see if they help improve symptoms and quality of life in people with IBD or RA. Participants are randomly assigned to one of these diets or a wait-list control group over about 24 weeks.

How Is the Trial Designed?

7

Treatment groups

Experimental Treatment

Active Control

Group I: Voluntary Crossover - Ketogenic Diet to Carnivore (Lion) Diet AFTER 12 weeksExperimental Treatment2 Interventions
Group II: Voluntary Crossover - Carnivore (Lion) Diet to Ketogenic Diet AFTER 12 weeksExperimental Treatment2 Interventions
Group III: Ketogenic Diet for 12 Weeks AFTER Wait-ListExperimental Treatment1 Intervention
Group IV: Ketogenic Diet 24 WeeksExperimental Treatment1 Intervention
Group V: Carnivore (Lion) Diet for 12 weeks AFTER Wait-ListExperimental Treatment1 Intervention
Group VI: Carnivore (Lion) Diet 24 WeeksExperimental Treatment1 Intervention
Group VII: Wait List 12 WeeksActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fuller Research Foundation

Lead Sponsor

Resilient Roots: Functional Medicine

Collaborator

Citations

Ketogenic and Carnivore (Lion) Diets for Inflammatory ...

The primary goal of this study is to determine whether ketogenic or carnivore dietary therapy improves, health-related quality of life, disease ...

Lion Diet Study

The primary goal of this study is to determine whether ketogenic or carnivore dietary therapy improves: Health-related quality of life; Disease specific symptom ...

Carnivore Diet: A Scoping Review of the Current Evidence ...

Individual publications reported positive effects of the CD, such as weight reduction, increased satiety, and potential improvements in inflammatory or ...

Ketogenic and Carnivore (Lion) Diets for Inflammatory ...

The primary goal of this study is to determine whether ketogenic or carnivore dietary therapy improves, health-related quality of life, disease ...

Case report: Carnivore–ketogenic diet for the treatment of ...

We report on 10 cases of IBD responsive to ketogenic, mostly carnivore, diets. Clinical presentations were diverse, including six cases of UC ...