Ketogenic Diet in Rheumatoid Arthritis (RA)

Last updated: February 5, 2024
Sponsor: University of Oklahoma
Overall Status: Active - Enrolling

Phase

N/A

Condition

Rheumatoid Arthritis

Inflammation

Dermatomyositis (Connective Tissue Disease)

Treatment

Ketogenic diet

Clinical Study ID

NCT05799768
2020H0090
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 studyenrollment)

Exclusion

Exclusion Criteria:

  • Chronic inflammatory/ autoimmune disease other than RA (e.g. gout, inflammatory boweldisease such as Crohn's disease or ulcerative colitis, lupus, myositis, etc.)
  • Prednisone or other glucocorticoid use in the last 4 weeks (exception: intra-articularglucocorticoid 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 studyenrollment)
  • Recent weight loss (>5% in the last 2 months)

Study Design

Total Participants: 6
Treatment Group(s): 1
Primary Treatment: Ketogenic diet
Phase:
Study Start date:
April 20, 2023
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oklahoma University Health Sciences Center

    Oklahoma City, Oklahoma 73003
    United States

    Site Not Available

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