Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
NCT07524244

Ketogenic and Carnivore (Lion) Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis

Led by Fuller Research Foundation · Updated on 2026-04-16

160

Participants Needed

1

Research Sites

80 weeks

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

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.

CONDITIONS

Official Title

Ketogenic and Carnivore (Lion) Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with medically verifiable inflammatory bowel disease or rheumatoid arthritis
  • Living in the continental United States
  • Willing and able to follow the dietary protocols
Not Eligible

You will not qualify if you...

  • Unable to provide consent
  • Diagnosis of Type 1 or Type II Diabetes treated with prescription medications including insulin
  • Outside the age range of 18 to 64 years or outside BMI criteria
  • No medically definitive diagnosis of inflammatory bowel disease or rheumatoid arthritis
  • History of strictures or fistula related to inflammatory bowel disease
  • Blood transfusion within the previous 6 months
  • Pregnant, breastfeeding, or within 6 months postpartum
  • Using medications outside of FDA-approved treatments
  • Started 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 cancer within the last year
  • Allergy to red meat or alpha-gal allergy

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Resilient Roots: Functional Medicine

Charlottesville, Virginia, United States, 22901

Actively Recruiting

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Research Team

R

Robert D Abbott, MD

CONTACT

E

Emily Palmer, MS, CNS

CONTACT

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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