No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 64
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
160 (estimated)
Sponsor
Fuller Research Foundation · Other
Who this trial is looking for
This trial is looking for adults with inflammatory bowel disease or rheumatoid arthritis. Participants will follow either a ketogenic diet or a carnivore diet for 24 weeks, reporting on their symptoms and quality of life throughout the study.
Are You a Good Fit for This Trial?
Rules you outOrgan failureHistory of malignancy in the past yearRed meat allergyAlpha-gal allergy
You may be able to join if
I have been diagnosed with inflammatory bowel disease or rheumatoid arthritis
I live in the continental U.S.
I am willing to follow specific dietary instructions
You may not be able to join if
I cannot provide consent
I have Type 1 or Type 2 diabetes and take insulin or other medications
I do not meet the age or BMI requirements
I do not have a clear diagnosis of inflammatory bowel disease or rheumatoid arthritis
I have a history of strictures or fistula related to IBD
I have received a blood transfusion in the past 6 months
I am pregnant
I am breastfeeding or have given birth in the last 6 months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 i…
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.
Trial Locations
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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 p…
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
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