Crohn'sUCRecruiting
Ketogenic and Carnivore (Lion) Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis
Not applicable · Testing Ketogenic diet and Carnivore (Lion) Diet · 1 site · Fuller Research Foundation
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Ketogenic diet (a behavioral program) and Carnivore (Lion) Diet (a behavioral program) as a possible treatment. Condition(s) listed: Rheumatoid Arthritis (RA), Crohn's Disease (CD) and Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 64
- Any sex
Some of the main requirements, copied from the record:
- Diagnosed with medically verifiable IBD or medically verifiable RA
- Current personal residence in the continental U.S.
- Willingness and ability to follow dietary protocols
There are also 16 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 160 participants are expected to take part.
- The study has 7 groups.
- Start date: 2026-02-17.
- Main results expected around 2027-09 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Ketogenic Diet 24 Weeks (listed as: experimental group)
- Carnivore (Lion) Diet 24 Weeks (listed as: experimental group)
- Wait List 12 Weeks (listed as: no-intervention group)
- Carnivore (Lion) Diet for 12 weeks AFTER Wait-List (listed as: experimental group)
- Ketogenic Diet for 12 Weeks AFTER Wait-List (listed as: experimental group)
- Voluntary Crossover - Ketogenic Diet to Carnivore (Lion) Diet AFTER 12 weeks (listed as: experimental group)
Main thing being measured
- Change in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36) (From baseline to 12 weeks)
In the researchers’ words
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…
Words you might see
- Randomized: participants are put into groups by chance, like a coin flip.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
- Fistula: an abnormal tunnel between two parts of the body, which can happen in Crohn's disease.
- Stricture: a narrowing (of the bowel or of a bile duct).
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Rheumatoid Arthritis (RA); Crohn's Disease (CD); Ulcerative Colitis (UC) |
| Lead sponsor | Fuller Research Foundation |
| Collaborators | Resilient Roots: Functional Medicine |
| Enrollment | 160 (estimated) |
| Start date | 2026-02-17 |
| Primary completion (est.) | 2027-09 |
| First posted | 2026-04-13 |
| Last updated | 2026-10-05 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07524244 |
Interventions
- Ketogenic diet (Behavioral)
The ketogenic diet is a high fat, moderate protein, and very low carbohydrate nutritional approach designed to shift the body's primary energy source from glucose to ketones, compounds produced in the liver from fat metabolism. This state of nutritional ketosis typically occurs when carbohydrate intake is restricted to 20-50 grams per day, though the exact threshold varies based on individual fact… - Carnivore (Lion) Diet (Behavioral)
The carnivore (lion) diet is a more restrictive form of a ketogenic diet that is intended as an elimination dietary protocol composed exclusively of ruminant meats (beef, lamb, bison, venison, goat, moose, elk), salt, and water. A broader carnivore diet includes more animal foods such as additional meats, fish, eggs, and some dairy. It excludes, however, all plant foods including vegetables, fruit…
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Resilient Roots: Functional Medicine | Charlottesville, Virginia | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.