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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• Diagnosed with medically verifiable IBD or medically verifiable RA

• Current personal residence in the continental U.S.

• Willingness and ability to follow dietary protocols

Locations
United States
Virginia
Resilient Roots: Functional Medicine
RECRUITING
Charlottesville
Contact Information
Primary
Robert D Abbott, MD
info@resilientrootsfxevomed.com
4342183425
Backup
Emily Palmer, MS, CNS
emily@resilientrootsfxevomed.com
Time Frame
Start Date: 2026-02-17
Estimated Completion Date: 2027-09
Participants
Target number of participants: 160
Treatments
Experimental: Ketogenic Diet 24 Weeks
Participants with IBD or RA randomized initially to receive dietary counseling regarding the ketogenic diet for up to 24 weeks
Experimental: Carnivore (Lion) Diet 24 Weeks
Participants with IBD or RA randomized initially to receive dietary counseling regarding the carnivore (lion) diet for up to 24 weeks
No_intervention: Wait List 12 Weeks
Participants with IBD or RA randomized initially to a 12 week waitlist who will continue their baseline dietary pattern WITHOUT specific dietary guidance/intervention
Experimental: Carnivore (Lion) Diet for 12 weeks AFTER Wait-List
Participants with IBD or RA randomized initially to the wait-list for 12 weeks who are then randomized to receive dietary counseling regarding the carnivore (lion) diet for a subsequent 12 weeks
Experimental: Ketogenic Diet for 12 Weeks AFTER Wait-List
Participants with IBD or RA randomized initially to the wait-list for 12 weeks who are then randomized to receive dietary counseling regarding the carnivore (lion) diet for a subsequent 12 weeks
Experimental: Voluntary Crossover - Ketogenic Diet to Carnivore (Lion) Diet AFTER 12 weeks
Participants with IBD or RA randomized initially to the ketogenic diet for 12 weeks who voluntarily choose to crossover to the carnivore (lion) diet intervention for the final 12 weeks
Experimental: Voluntary Crossover - Carnivore (Lion) Diet to Ketogenic Diet AFTER 12 weeks
Participants with IBD or RA randomized initially to the carnivore (lion) diet for 12 weeks who voluntarily choose to crossover to the ketogenic diet intervention for the final 12 weeks
Sponsors
Leads: Fuller Research Foundation
Collaborators: Resilient Roots: Functional Medicine

This content was sourced from clinicaltrials.gov

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