Ketogenic Diet in Rheumatoid Arthritis (RA)

Study Overview
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Brief Summary
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This is a 6-week ketogenic diet (KD) intervention where participants with rheumatoid arthritis (RA) will follow a KD plan, supervised and monitored by a dietician. Participants will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home blood ketone/glucose monitors, along with diet records. Participants will fill out health related questionnaires and undergo assessments of body composition, RA disease activity. This study also includes blood draws and fat biopsy of the abdominal region.

Official Title
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Ketogenic Diet Intervention in Patients With Rheumatoid Arthritis (RA): a Pilot Study

Conditions
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Rheumatoid Arthritis, Inflammation, Obesity, Ketogenic Dieting, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Ketogenic diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of RA according to the ACR/EULAR 2010 criteria for RA. On stable doses of DMARDs and/ or biological agents (≥ 2 months prior to study enrollment) Exclusion Criteria: Chronic inflammatory/ autoimmune disease other than RA (e.g. gout, inflammatory bowel disease such as Crohn's disease or ulcerative colitis, lupus, myositis, etc.) Prednisone or other glucocorticoid use in the last 4 weeks (exception: intra-articular glucocorticoid injections) Insulin use Hospitalization in the 30 days prior to study enrollment Acute or uncontrolled disease (e.g. cirrhosis, COPD, CKD) Malignancy Chronic infection (HIV, hep B/C, etc.) Heavy drinking On a ketogenic diet or exogenous ketone supplement (lses than 3 months prior to study enrollment) Recent weight loss (>5% in the last 2 months)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic diet plan<br>Subjects will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home whole capillary blood ketone/glucose monitors, along with diet records. We will assess adherence based on days in ketosis following these parameters: (BHB ≥ 0.5mM). Adherence will be defined as > 80% of days in ketosis. | Behavioral: Ketogenic diet<br>* Ketogenic diet counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hsCRP | Systemic marker of inflammation | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAS28-CRP | RA disease activity measure | 6 weeks |