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New treatment option for Rheumatoid Arthritis (RA)
Official title Ketogenic and Carnivore (Lion) Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT07524244
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Diagnosed with medically verifiable IBD or medically verifiable RA
- Current personal residence in the continental U.S.
- Willingness and ability to follow dietary protocols
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.