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Ketogenic and Carnivore (Lion) Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis

ConditionsRheumatoid Arthritis (RA)Crohn's Disease (CD)Ulcerative Colitis (UC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorFuller Research Foundation

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with medically verifiable IBD or medically verifiable RA

Current personal residence in the continental U.S.

Willingness and ability to follow dietary protocols

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 factors such as muscle mass, insulin sensitivity, and physical activity. Participants will receive nutritional guidance for the ketogenic diet in a virtual setting via both synchronous and asynchronous engagement including group telehealth sessions, dietary education guides/food lists, quantitative sample meals plans and ongoing messaging capacity with the clinical team for the duration of the dietary intervention.

  • 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, fruits, grains, legumes, nuts, seeds, or plant-derived oils. Participants will receive nutritional guidance for the carnivore (lion) and the broader carnivore diet in a virtual setting via both synchronous and asynchronous engagement including group telehealth sessions, dietary education guides/food lists, quantitative sample meals plans and ongoing messaging capacity with the clinical team for the duration of the dietary intervention.

Treatment groups

160 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Ketogenic Diet 24 WeeksExperimental treatment 1 intervention
Group B: Carnivore (Lion) Diet 24 WeeksExperimental treatment 1 intervention
Group C: Wait List 12 WeeksNo intervention 0 interventions
Group D: Carnivore (Lion) Diet for 12 weeks AFTER Wait-ListExperimental treatment 1 intervention
Group E: Ketogenic Diet for 12 Weeks AFTER Wait-ListExperimental treatment 1 intervention
Group F: Voluntary Crossover - Ketogenic Diet to Carnivore (Lion) Diet AFTER 12 weeksExperimental treatment 2 interventions
Group G: Voluntary Crossover - Carnivore (Lion) Diet to Ketogenic Diet AFTER 12 weeksExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in health-related quality of life measured using the 36-Item Short Form Health Survey (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 subscale.

Time frame
From baseline to 12 weeks

Secondary outcomes

1

Change in health-related quality of life measured using the 36-Item Short Form Health Survey (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 subscale.

Time frame
From baseline to 24 weeks
2

Change in Rheumatoid Arthritis Disease Activity Index-5 Questionnaire (RADAI-5)

RADAI-5 is a 5-item questionnaire designed to assess rheumatoid arthritis symptomatic activity. Scores for each item are on a 0-10 scale. Higher scores indicate worse outcome/symptoms. \*\*RA only\*\*

Time frame
From baseline to 12 and 24 weeks
3

Change in Routine Assessment of Patient Index Data (RAPID-3)

RAPID-3 is a questionnaire used to monitor rheumatoid arthritis symptoms and disease activity by measuring a participant's functional status, pain, and overall perception of health. Scores range from 0-30; higher scores indicate worse outcome." \*\*RA only\*\*

Time frame
From baseline to 12 and 24 weeks
4

Change in Inflammatory Bowel Disease Symptom Inventory - Short Form (IBDSI-SF)

The IBDSI-SF measures the frequency and severity of IBD related symptoms as well as their interference with overall functioning and daily activities. We are using a version with 23 questions that excludes the bowel complications subscale - questions 24 and 25 related to fistulas given this as an exclusion criteria. 22 of the 23 questions are scored on a 0-4 scale with higher scores reflecting worse outcome/symptoms. 1 question is rated on a 0-2 scale with a higher score reflecting a worse outcome/symptom. Total scores range from 0-90, higher scores indicating worse outcomes. \*\*IBD only\*\*

Time frame
From baseline to 12 and 24 weeks

Other outcomes

1

Change in body composition (weight and BMI)

Body composition will be assessed periodically via bioelectrical impedance analysis using a provided Omron HBF-514C Body Composition Monitor. The scale will directly measure body weight and this will be self reported by participants in pounds (lbs) or kilograms (kg) depending on scale setting.. These self reported measurements of weight will be aggregated with a baseline self report of height in inches to calculate associated BMI (kg/m\^2).

Time frame
From baseline to the end of the study intervention at 24 weeks
2

Change in body composition (skeletal muscle mass)

Body composition will be assessed periodically via bioelectrical impedance analysis using a provided Omron HBF-514C Body Composition Monitor. The scale will provide a direct measurement of skeletal muscle mass measured in kilograms (kg).

Time frame
From baseline to the end of the study intervention at 24 weeks
3

Change in body composition (body fat percentage)

Body composition will be assessed periodically via bioelectrical impedance analysis using a provided Omron HBF-514C Body Composition Monitor. The scale will provide a direct measurement of skeletal muscle mass measure in kilograms as well as body weight in kilograms. The scale will provide a calculation of body fat percentage based on these measurements).

Time frame
From baseline to the end of the study intervention at 24 weeks
4

Change in body composition (visceral fat estimation)

Body composition will be assessed periodically via bioelectrical impedance analysis using a provided Omron HBF-514C Body Composition Monitor. The scale will provide a estimated measurement of visceral fat. This measurement is reported as a unitless proprietary index (range 1-30); higher scores indicate greater visceral adiposity.

Time frame
From baseline to the end of the study intervention at 24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fuller Research Foundation

Lead sponsor

Resilient Roots: Functional Medicine

Collaborator

Source ClinicalTrials.gov
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