Lion Diet Study Research Page

Study 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

Study Introduction

The intention of our collaborative research team is simple – help improve the lives of our study participants and add critical initial knowledge to the paucity of peer reviewed research currently available for animal based eating patterns (carnivore and lion diets) in the treatment of chronic disease. We are a private group independent of industry and corporate influence and we strive to be both efficient and transparent with the study procedures. Upon initiation of the study proper, we will provide specific updates about the utilization of study funds, enrollment of study participants and progression of the participants through the study program. While we have an initial target of ~160 study participants for the full statistical analysis (based on projected drop-out and completion rates), we look forward to sharing study observations as able with the initial study cohort. In the commentary below you will find additional details about the study design and procedures. While not exhaustive, we hope the information below provides an accessible, but rigorous look at our efforts for the first randomized controlled trial assessing the effects of a carnivore (lion) diet on any chronic disease state.

Thank you to all who have donated to the study so far and we appreciate everyone’s support of this collective effort!

Study Overview

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 (IBD) or rheumatoid arthritis (RA).

Participants, stratified by disease, will be randomized to one of three groups:

Ketogenic Diet
Carnivore (Lion) Diet
Wait-List Control (transitioning to a diet arm after 12 weeks)

Total participation time is approximately 27 weeks including a 3-week baseline run-in and a 24-week dietary intervention period divided into 2, 12-week phases.

We are aiming for 160 total enrolled participants to be included in the final statistical analysis (estimating drop outs). Study participants will complete the formal study in cohorts to reach this total goal.

Purpose of the Study

The primary goal of this study is to determine whether ketogenic or carnivore dietary therapy improves:

Health-related quality of life
Disease specific symptom burden
Objective inflammatory markers

Given the limited prospective data on carnivore (lion) diet approaches for addressing autoimmune conditions, the study aims to assess feasibility of implementation as well as overall safety including the documentation of common adverse events, changes to nutritional status or changes to cardiometabolic status including blood lipids.

The study will also evaluate differences between dietary approaches and explore whether sustained nutritional ketosis correlates with clinical outcomes.

Conditions Being Studied

Inflammatory Bowel Disease (Crohn’s Disease and Ulcerative Colitis)
Rheumatoid Arthritis

Both are chronic autoimmune and inflammatory diseases associated with significant symptom burden and quality of life impact. Current therapeutics are often limited to expensive, “biologic” immune modulating medication with significant adverse effect potential and, at times, limited financial coverage and availability.

Contacts and Locations

The study is being conducted in a virtual capacity with participants across the US.

The primary clinical location for the principal investigator is:

Resilient Roots: Functional Medicine

355 Rio Rd W, Suite 206

Charlottesville VA, 22901

Participation Criteria

General Eligibility

Adults ages 18–64 (at time of enrollment)
Medically confirmed IBD or RA (provide the medical team with confirmation of diagnosis)
BMI corresponding to normal weight, overweight and class I obesity
Residence in the continental United States
Willingness to follow structured dietary protocol for 12-24 weeks

Selected Exclusion Factors

Pregnancy or breastfeeding
Recent biologic or disease-modifying therapy initiation
Certain major medical conditions or organ failure
Insulin-treated diabetes
Red meat allergy (alpha-gal syndrome)
Microscopic colitis (lymphocytic or collagenous colitis)

Study Plan

3 “Studies” in 1 Trial

This study is designed as a single prospective intervention that combines three complementary research approaches into one cohesive clinical trial. By integrating multiple study elements, we are able to evaluate short-term effectiveness, long-term sustainability, and real world individual response all within the same participant population.

Randomized Controlled Comparison (Phase I – Weeks 0–12)

Participants will be randomly assigned to one of three groups: Lion Diet, Ketogenic Diet, or Wait-List Control. This phase allows us to directly compare short-term symptom improvement, quality of life outcomes, and disease activity markers between active dietary interventions and a control group.

Long-Term Durability Comparison (Phase II – Weeks 12–24)

Participants who begin one of the active dietary interventions can continue their assigned diet through week 24. Individuals will also be able to voluntarily crossover to the other dietary intervention at the start of Phase II should they have inadequate treatment response or persistent adverse side effects from Phase I. This phase evaluates sustainability, adherence, and longer-term metabolic and immune effects, while allowing direct comparison between the two dietary strategies over time.

Delayed-Start Self-Controlled Cohort

Participants initially assigned to the wait-list group will begin an active dietary intervention after week 12. This allows us to evaluate within-person changes before and after starting the diet, providing an additional layer of evidence and helping ensure all participants have access to an active intervention. This can also be considered as a “nested” crossover subgroup within the larger study.

Why This Study Design Matters

This integrated design allows us to:

Maintain the scientific rigor of a randomized controlled trial
Evaluate long-term real world sustainability of dietary interventions
Measure individual response patterns using delayed-start comparisons
Improve participant access and ethical balance by offering active interventions to all participants
Include a rigorous control group that can be used to extrapolate expected clinical status at 24 weeks

By combining these approaches into a single study, we can generate more clinically meaningful data in an efficient manner while maintaining high research standards.

Dietary Interventions

Ketogenic Diet
High fat, moderate protein, very low carbohydrate dietary pattern designed to promote nutritional ketosis.

Carnivore (Lion) Diet
Elimination diet consisting primarily of ruminant meats, salt, and water, designed to minimize dietary immune triggers.
Participants will receive structured education, telehealth support, and clinical monitoring throughout the study. Diet groups will be able to participate in monthly group zooms for education and ongoing clinical support.

Outcomes Measured

Primary Outcome

Health-related quality of life measured using the SF-36 survey.

The survey has 8 core subscales encompassing physical, social and emotional elements of quality of life.

Secondary Outcomes

Disease Specific Symptoms (participant questionnaires)

RADAI-5 and RAPID-3 (RA participants)
IBDSI-SF (IBD participants)

Inflammatory Lab Markers

hs-CRP
ESR
White blood cell and immune cell differentials
Fecal calprotectin (IBD participants)

Safety and Feasibility Analysis

Micronutrient status
Cardiometabolic status
Metabolic markers including at home blood ketones and blood glucose
Treatment adherence and preference
Body composition (at home scale)

Exploratory Outcomes

Gut microbiome composition, stool chemistries
Neurocognitive (IQ testing) and personality assessments

Study Procedures

Participants complete:

Randomization and run-in period

Participants will be randomized in a 2-2-2 schema, stratified by disease state (IBD or RA), to the Carnivore (Lion) Diet, Ketogenic Diet, or Wait-List group.
Participants will receive an at-home blood ketone and glucose monitoring kit (Keto-Mojo) and a digital body composition scale.
Participants will discontinue any supplements started within one month of study enrollment.

Baseline questionnaires and assessments

Baseline quality-of-life, psychometric, and disease-specific symptom questionnaires
Baseline body composition assessment and historical food frequency
Baseline qualitative and quantitative analysis of self reported dietary intake

Baseline laboratory testing

Baseline at-home finger-stick blood ketone and glucose monitoring
Baseline fasted blood collection and at-home stool collection

Dietary intervention and support

Participants will receive educational materials, including recommended foods and structured meal plans, with ongoing access to nutrition providers.
Participants will join scheduled group telehealth sessions tailored to their dietary intervention to review study procedures, ask questions, and receive support within a community of fellow participants.
Participants will receive ongoing telehealth monitoring from the medical and nutritional staff

Follow up

Ongoing quality-of-life, psychometric, and disease-specific symptom questionnaires at specified time points
Ongoing dietary adherence and health progress questionnaires
Ongoing qualitative and quantitative analysis of self reported dietary intake
Ongoing biometrics and laboratory testing at specified time points

Lab Testing

Body Composition Scale (at home) – Omron HBF-514C

Blood Glucose and Blood Ketone Testing (at home) – Keto Mojo

Stool Testing – Gi Effects Stool Testing with H. Pylori and Zonulin Add ons

Quest Lab Serology

Metabolic and Liver Function

Comprehensive Metabolic Panel (CMP)
Gamma Glutamyl Transferase (GGT)
Lactate Dehydrogenase (LDH)
Creatine Kinase (CK), Total
Uric Acid

Nutrient Status

Iron, TIBC, and Ferritin Panel
Magnesium
Zinc
Copper
Ceruloplasmin
Vitamin B12 (Cobalamin)
Folate, Serum
Vitamin D, 25-Hydroxy, Total
Vitamin C
Homocysteine
Thiamine (B1)
Iodine

Thyroid Function

TSH
Free T4
Free T3

Blood Sugar

Hemoglobin A1C
Insulin
C-Peptide

Lipids

Lipid Panel, Standard
Apolipoprotein B
Lipoprotein A

Immune and Inflammatory Markers

Immunoglobulins Panel (IgA, IgG, IgM)
IgE
Rheumatoid Arthritis Diagnostic Panel (RF, anti-CCP)
CBC with differential and platelets
hs-CRP
ESR

Key Study Risks (taken from the approved Informed Consent)

Overall Risks

There is a risk that participants will find some discomfort in changing their diets as recommended by the study team. Discomfort may include temporary constipation, fatigue, nausea, food aversions, brain fog and headaches due to diet changes. However, there will be no intentional caloric deficits.

Ketogenic diets including a carnivore (lion) diet have been associated with lower blood pressure (hypotension), low blood sugar (hypoglycemia), raising uric acid levels which could cause a gout flare in at risk individuals, kidney stones, and changes to lipid profiles including increases in total cholesterol, LDL-C and apoB (the number of certain cholesterol carrying particles). Certain forms of lower protein and calorically restricted ketogenic diets have been associated with bone mineral density changes. In addition, the intake of processed red meat has been associated in some epidemiologic (observing populations over time) studies with small increases in colorectal cancer risk. In light of this association, the study team will focus primarily on the INCLUSION of UNPROCESSED meat consumption and will discourage regular consumption of PROCESSSED meats.

In making dietary eliminations, there is a risk of removing food providing certain key nutrients resulting in nutritional deficiencies or reducing total caloric intake resulting in weight loss. As such, the nutritional and medical teams are providing specific guidance and oversight during the dietary eliminations and will be monitoring nutritional status via key laboratory measures as participants provide self-monitoring of any undesired changes in body composition. Participants, including, and primarily, women of childbearing age will be allowed to take an approved folate containing supplement for the duration of the study.

There may be some risks to study participants that the study team does not know about yet, and we hope to better identify such risks to educate the broader public as part of this controlled study.

Procedural Risks

Blood collection for laboratory analysis may result in pain, swelling or bruising at the collection site, nerve irritation, skin irritation, and dizziness or fainting. While severe reactions are rare, there is a small risk of infection, abnormal clotting or abnormal bleeding.

Blood collection by finger stick for the blood glucose and blood ketone readings can result in local irritation, swelling and in rare cases infection. Virtual education regarding proper technique for at home finger stick collection will be provided by the study team to minimize such risks

The study questionnaires ask personal questions that are sensitive in nature and may make you feel uncomfortable.

Statistical Plan

A LOT can be said about statistics and our goal with this study is to present the data in a clinically relevant manner. Here are some essential concepts to know about the study’s statistical plan.

The MOST important takeaway is we plan to conduct multiple statistical analyses that take into account ALL the people who start and where they end up as well as selected subgroups of participants who actually complete the full study protocol as intended (actually followed the dietary protocol to some reasonable degree). Dropouts and incomplete data are unfortunately common and par for the course in any clinical trial, and especially so for more rigorous dietary interventions such as what we are attempting. We want to get a realistic idea of how difficult it may be to implement these diets and if one dietary pattern appears clinically (not just statistically) more helpful.

Said more technically, we plan to conduct statistical evaluations that examine both the effectiveness (intention-to-treat) and efficacy (per-protocol) of the dietary interventions as it pertains to our primary outcome measure – health related quality of life (SF-36).

The SF-36 consists of 8 subscales including: physical functioning, role limitations due to physical health (physical role functioning), role limitations due to emotional problems (emotional role functioning), vitality, mental health, social role functioning, bodily pain and general health. Scores for each subscale will be on a 0-100 scale with higher scores generally reflecting better health or less functional impairment for that respective subdomain.

Effectiveness (Intention-to-Treat Analysis)

Effectiveness will be assessed using an intention-to-treat (ITT) analysis, which includes all participants who were enrolled in the study, regardless of their level of adherence or study completion status (ex. withdrawal status or voluntary cross-over). This approach evaluates how the dietary guidance performs under real-world conditions, taking into account the challenges of implementation, participant variability, and attrition. The ITT analysis will be used to examine the primary outcome measure, providing an estimate of the intervention’s practical impact when applied in a general population. This method maintains the advantages of randomization and supports external validity by reflecting a more realistic scenario of how the intervention might perform in standard practice.

Efficacy (Per Protocol Analysis)

Efficacy will be assessed by evaluating the intervention’s performance under ideal conditions, specifically among participants who adhered to the dietary guidance protocol AND for whom we have completed study data – (ex. questionnaires, lab tests, etc). This analytic approach allows for an evaluation of the intervention’s potential effect when implemented as designed and followed as intended. Additional per protocol analyses may be conducted based on more unique findings or occurrences in the study (ex. strongest dietary adherence, medication status, change in medical status, etc).

Study Sponsor, Funding and Independence

The principal investigator is Rob Abbott, MD. The study sponsor is Fuller Research Foundation.

Participants will provide a $200 partially refundable fee to participate. Participants can receive a $100 refund for completing the complete study procedures.

Current crowd funding efforts seek to cover the largest study cost that is laboratory assessments.

No pharmaceutical, food industry, or corporate sponsorship is involved.

The principal investigator and supporting medical and nutritional staff are not affiliated with any commercial entities that would benefit directly from the study’s outcomes.

Study Record and Oversight

The study protocol has been reviewed and approved by BeyondBound IRB. Initial approval was obtained on June 24th, 2025 and any subsequent amendments will be sent to the IRB noted above.

Contact and Address

1980 Festival Plaza Dr. Suite 300, Las Vegas NV 89135
info@beyondbound.org
646-217-0403