Ketogenic Diet in Rheumatoid Arthritis (RA)

NCT ID: NCT05799768

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2029-12-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Ketogenic diet plan

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.

Group Type: EXPERIMENTAL

Ketogenic diet

Intervention Type: BEHAVIORAL

Ketogenic diet counseling

Interventions

Ketogenic diet

Ketogenic diet counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rheumatology Research Foundation

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

2020H0090

Identifier Type: -

Identifier Source: org_study_id