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Enrolling by Invitation

NCT Number: NCT05799768

Ketogenic Diet in Rheumatoid Arthritis (RA)

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Body Weight Connective Tissue Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Inflammation Insulin Resistance Joint Diseases Ketogenic Dieting Metabolic Diseases Metabolic Syndrome Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73003, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ketogenic diet

Behavioral

Ketogenic diet counseling

Primary outcomes

  1. hsCRP

    Time frame: 6 weeks

    Systemic marker of inflammation

Secondary outcomes

  1. DAS28-CRP

    Time frame: 6 weeks

    RA disease activity measure

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Rheumatology Research Foundation

Registry information

Official study title

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

Acronym: KETORA

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Apr 5, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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