Ketogenic Diet in Rheumatoid Arthritis (RA) (KETORA)

University of Oklahoma (OU)

Status: Invitation-only

Conditions: Inflammation; Ketogenic Dieting; Obesity; Metabolic Syndrome; Rheumatoid Arthritis

Treatments: Behavioral: Ketogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05799768

2020H0090

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Ketogenic diet plan

Experimental group

Description:

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.

Treatment:

Behavioral: Ketogenic diet